Emerging Treatment Options for Venous Ulceration in Today`s

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Supplement to
Emerging Treatment
Options for Venous
Ulceration in Today’s
Wound Care Practice
This supplement was published as an online article with Ostomy Wound Management
and subject to the OWM peer-review process. It was not subject to the WOUNDS
peer-review process and is provided as a courtesy to WOUNDS subscribers.
Supported by Covidien
Emerging Treatment Options for Venous Ulceration in
Today’s Wound Care Practice
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clinical outcomes will be reviewed. The newest
treatment options, including minimally invasive therapy will be described. The current literature will be
reviewed. A new algorithm for treatment that integrates the endovascular treatment of venous insufficiency into the current standard care for venous
leg ulceration will be proposed. Method. A literature
review was performed to review all current treatments for venous ulceration. Treatments that have
Level I evidence (with a grade of recommendation
of A or B) to support their use for venous leg ulceration were selected for incorporation into a new
treatment algorithm. The level-of-evidence and
strength-of-recommendation scheme used in the algorithm is based upon the system used by the
Wound Healing Society in its chronic wounds clinical
practice guidelines. Conclusion. It is intended that
this new algorithm and approach to treatment will
improve the immediate care of venous leg ulcer patients, reduce recurrence rates, increase patient satisfaction, and potentially expedite initial wound
healing in the outpatient wound clinic setting.
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Abstract: Lower-extremity ulcers represent the
largest group of ulcers presenting to an outpatient
wound care clinic and, of those, ulcers due to venous insufficiency and venous hypertension make
up the largest subgroup of these ulcers. Interventions for chronic venous ulcers have evolved to painless, minimally invasive, office-based procedures
performed under local anesthesia. Recent advances
in the endovascular management of lower-extremity
superficial venous insufficiency have the potential to
significantly enhance initial and long-term management of these patients, as minimally invasive procedures provide faster recoveries and fewer procedural
risks. Early intervention for venous insufficiency has
been shown to significantly decrease long-term
ulcer recurrence rates, and may increase healing of
venous ulcers as well. Purpose. The purpose of this
review and algorithm is to enhance understanding
of venous ulceration and its underlying causes. Venous anatomy and pathophysiology will be reviewed. The etiology of chronic venous ulceration
will be examined. Current practice guidelines and
Ostomy Wound Management 2010;56(online suppl):E1-E10.
guideline
endovascular treatments
algorithm
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MESH key words:
venous insufficiency
venous ulcer
treatment
Table of Contents
3 Venous Ulcers of the Legs — Treatable and
Preventable
Robert L. Kistner, MD
Clinical Professor of Surgery
University of Hawaii
John A. Burns School of Medicine
Honolulu, HI
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5 Review and Benefits of Non-invasive
Diagnostic Ultrasound and Thermal Ablation
Randy Shafritz, MD, FACS
Director, University Vein Center
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, NJ
Karl R. Stark, MD, FACS
Clinical Associate Professor of Surgery
University of Missouri School of Medicine
Kansas City, MO
8 A New Algorithm for the Evaluation and
Treatment of Venous Leg Ulcer Patients in
the Outpatient Wound Care Clinic
Robert A. Warriner III, MD, FACA, FCCP FCCWS,
ABPM/UHM
Chief Medical Officer
Diversified Clinical Services
Jacksonville, FL
Founding and Emeritus Medical Director
Southeast Texas Center for Wound Care
and Hyperbaric Medicine
Conroe Regional Medical Center
Conroe, TX
Supported by Covidien.
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EMERGING TREATMENT OPTIONS FOR VENOUS ULCERATION IN TODAY’S WOUND CARE PRACTICE
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Venous Ulcers of the Legs — Treatable and Preventable
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Robert L. Kistner, MD
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here is great opportunity to fundamentally improve treatment results in venous leg ulceration. Leg ulcers are one of the largest
single groups of ulcers treated in wound care centers in the
United States, making up as much as 80% of leg ulcer series.1
Presently accepted statistics indicate that venous ulcers require an
average of 24 weeks to heal; approximately 15% never heal; and
recurrence is found once or multiple times in 15%–71% of cases.2,3
In reported populations of venous ulcers, 15%–71% are found to
be recurrent lesions.4 The cost of treatment for venous ulcers in the
United States is estimated to be $1–$5 billion annually.1
In a venous ulcer, the extremity must have reflux in the superficial
or deep veins or in sites of obstruction in the venous outflow sufficient
to be a cause of ulceration in the observed site. These findings require
an objective imaging test, usually a non-invasive venous duplex scan.
There are “pure” venous ulcers, in which the only identifiable
cause for ulceration is found in the venous system; and “mixed”
venous ulcers, in which other factors exist that are capable of creating a leg ulcer in addition to the venous abnormality. Examples
of such other causes include arterial insufficiency, lymphatic insufficiency, obesity, rheumatologic autoimmune disorders, and a long
list of other unusual disorders.
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nous duplex ultrasound examination that is
available worldwide. In 1994, a new classification
of chronic venous disease was developed and
subsequently refined.5 This has become the
dominant international standard. The CEAP
(clinical, etiologic, anatomic, and pathophysiologic) classification covers the four key aspects
of the chronic venous condition.
Since then, published studies have become
better standardized to report these critical aspects
of the clinical cases, allowing for correlation of
clinical states with anatomic distribution of sites
of reflux and obstruction, segment by segment
throughout the lower-extremity venous tree. It
is now possible to safely and affordably observe
the reflux and obstructive changes in the veins
that underlie the appearance of venous ulcers.
At the same time, minimally invasive outpatient techniques have emerged to correct underlying venous defects and provide protection
against recurrence once an ulcer is healed.
Armed with accurate anatomic data for sites of
reflux and obstruction, the surgeon or treating
interventionalist can focus treatment on these critical sites.
Thermal ablation has further improved minimally invasive
treatments 6 of the saphenous and perforator veins. Offlabel
use of liquid and foam sclerotherapy allows for more precise
delivery to sites in the perforator and saphenous veins, in addition to conventional use in the peripheral varices.
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TREATMENT OPTIONS HAVE ADVANCED
An attitude that venous ulcers are not curable and are destined to recur in the majority of instances developed when
the diagnosis of a venous cause for an ulcer was based on soft
clinical impressions without objective substantiation. Further,
treatment was directed at simple closure of the skin wound
without correction of the underlying venous abnormality.
The cogent reasons for these attitudes have been changed
during the past three decades with the advent of improved
diagnosis using objective ultrasound imaging and the introduction of minimally invasive treatment techniques and
highly focused interventions.
The key to these advances in managing venous ulcers has
been the emergence of accurate, affordable, noninvasive ultrasound diagnosis of lower-extremity veins. Leg vein imaging
by ultrasound emerged as the dominant diagnostic test in the
1980s and was refined for another decade into the present ve-
CAUSES AND CLINICO-PATHOLOGIC
COURSES OF ULCER FORMATION
The two important causes of venous ulceration are primary
degenerative disease and post-thrombotic disease. One-half
to two-thirds of venous ulcers are due to slowly progressive
primary reflux disease that begins as varicose veins.
Over decades, a pure venous reflux problem with asymptomatic varicose veins progresses to a stage of variable discomfort,
often with swelling, followed by a more advanced stage in
which skin changes emerge and lead to ulceration. The skin
changes often begin with brownish pigmentation, which proS uppl e me nt to Wounds
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OPPORTUNITIES FOR DECREASING
THE OCCURRENCE OF ULCERATION
The concept of life-long development of primary venous
insufficiency leading to the late appearance of venous ulceration is important.This knowledge allows the primary physician to observe the status of the patient over a longitudinal
time span and refer the patient for definitive diagnostic studies
as the early varicose veins progress from aching pain and leg
heaviness, to swelling, to skin changes.
Along this path, a definitive venous scan should be done,
along with arterial evaluation with ankle/brachial ratios, to establish the validity of using compression wraps when the patient reaches later stages of the process. Ideally, the patient
would be treated for axial superficial reflux when symptoms
warrant treatment or when skin changes develop, before the
first ulcer appears.When the disease has progressed to the first
ulcer, immediate referral to the wound care or venous specialist is warranted to check the venous and arterial circulations,
and to institute effective removal of axial venous reflux in the
subcutaneous and perforator veins.This should be done at the
same time that conventional pressure therapy is used to heal
the ulcer. Failure to correct the axial reflux results in markedly
higher ulcer recurrence rates7–9 and should be avoided.
Combined obstructed and reflux disease due to scarring of
the deep veins are likely in post-thrombotic ulceration. Often,
there is superficial vein reflux due to associated primary disease. Managing these cases involves using effective compression with support stockings or garments and selective
anticoagulation to prevent recurrent thromboses. Superficial
reflux should be eliminated when the deep veins are found
adequate to maintain venous return — a determination that
can be evaluated with plethysmographic and volume outflow
studies in the vascular laboratory.
earlier this determination can be made, the better for the
long-term outlook. Delay in diagnosis may result in
chronic scarring of the distal leg tissues, creating an extremity in which the distal tissues are too fibrotic to sustain a healthy state.
2. Early application of compression should be performed to
correct swelling and progressive scarring and to initiate the
healing process by improving the venous microcirculation.
3. Aggressive correction of axial reflux in the superficial and
perforator veins of the affected leg should be performed.
The use of the newer minimally invasive techniques of
thermal ablation and selective sclerotherapy facilitates patient acceptance and outpatient ambulatory treatment.
4. Surveillance of the leg for new recurrent or progressive
venous disease should be ongoing for the indefinite future.This can be done by the venous specialist or the informed primary physician.
5. The medical profession should change its attitude fundamentally to view chronic venous disease as a chronic
degenerative malady that can be managed effectively to
minimize the occurrence of both initial and recurrent
ulcers.The primary physician needs to be engaged in the
care of this disease entity.
6. Specialist attitudes must change to view venous leg ulcers
as diagnosable and treatable, with recognized patterns of
reflux and obstruction that can be successfully managed
to minimize occurrence and recurrence of lower leg ulcers in the majority of cases.
7. Leg ulcer patients should be referred to wound care
centers or venous specialists for definitive diagnosis and
treatment early — ie, before the tissues of the lower leg
become irreversibly scarred from prolonged swelling
and venous hypertension. ■
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gresses into dermal and subcutaneous thickening and scarring,
and later results in tissue breakdown with ulcer formation.The
risk of this conversion increases as patients reach 60–70 years.
The other one-third to one-half of venous ulcers develop
after deep vein thrombosis (DVT) and are prone to advance
more rapidly to the ulcer stage in periods from 6 months to
several years after the DVT event. These cases also have
brownish discoloration of the skin — the so-called postphlebitic appearance of pigmented, thickened, swollen legs.
The clinical appearance of ulcers from primary venous reflux
disease and post-thrombotic deep vein changes are similar
enough that diagnosis of the ulcer’s cause requires an imaging
examination by duplex scan in every case.
SPECIFIC STEPS TO EFFECTIVE
MANAGEMENT OF VENOUS ULCERATION
In the author’s practice, the prescription for effective treatment of venous leg ulcers and prevention of the first or the
recurrent ulcer has several key elements:
1. Early, accurate diagnosis of the venous defect and stratification into pure and mixed venous ulcers is crucial.The
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References
1.Valencia IC, Falabella A, Kirsner RS, Eaglstein WH. Chronic venous
insufficiency and venous leg ulceration. J Am Acad Dermatol.
2001;44(3):401–421.
2. Kurz N, Kahn SR, Abenhaim L, et al., eds.VEINES Task Force Report:
The management of chronic venous disorders of the leg (CVDL): an evidence-based report of an international task force. McGill University. Sir
Mortimer B. Davis-Jewish General Hospital. Summary reports in: Angiology. 1997;48(1):59–66; and Int Angiol. 1999;18(2):83–102.
3. Heit JA.Venous thromboembolism epidemiology: implications for prevention and management. Semin Thromb Hemost. 2002;28(suppl 2):3–13.
4. Coleridge-Smith PD. In: Negus D, Coleridge-Smith PD, Bergan JJ, eds. Leg
ulcers. Diagnosis and Management. London, UK: Hodder Arnold; 2005: 12.
5. Eklof B, Rutherford RB, Bergan JJ, et al. Revison of the CEAP classification for
chronic venous disorders: Consensus statement. J Vasc Surg. 2004;40(6):1248–1252.
6. Merchant RF, DePalma RG, Kabnick LS. Endovascular obliteration of
saphenous reflux: a multicenter study. J Vasc Surg. 2002;35(6):1292–1294.
7. Barwell JR, Davies CE, Deacon J, et al. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR
study): randomised controlled trial. Lancet. 2004;363(9424):1854–1859.
8. vanGent W, Wijnand B, van Praag, et al. Conservative versus surgical treatment of venous leg ulcers: a prospective, randomized, multicenter trial. J Vasc Surg. 2006;44(3):563–571.
9. Gohel MS, Barwell JR, Taylor M, et al. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): Randomised controlled trial. BMJ.
2007;335(7610):83.
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Review and Benefits of Non-Invasive
Diagnostic Ultrasound and Thermal Ablation
Randy Shafritz, MD, FACS
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Karl R. Stark, MD, FACS
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reatment of chronic venous leg ulcers has long centered on
graduated compression therapy. Although this therapy is a
major component of wound healing, it fails to prevent recurrences. Poor long-term adherence and suboptimal results with compression alone, even in the most adherent patients, has driven the
search for a better option.1
State-of-the-art surgical treatment for all forms of venous disease —
from spider veins to venous ulceration — increasingly depends on an
accurate anatomic and physiologic assessment of both the superficial
and deep venous systems of the lower extremities. This can be accomplished with a comprehensive venous duplex scan of the lower extremity
venous system. When performed correctly by an experienced vascular
technician, this highly sensitive and specific noninvasive test is extremely
accurate for diagnosing venous disease of the lower extremities.
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ulceration. The information gained from the
evaluation is necessary to direct specific surgical treatment.
The evaluation is a complete mapping of
the deep and superficial venous systems, from
the inguinal ligament to the foot. There are
three systems of veins in the lower extremities: deep, superficial, and perforating. The
anatomy and physiology of each of the three
venous systems is completely evaluated. The
great saphenous, small saphenous, intersaphenous, accessory saphenous, and all incompetent perforating veins are sized and the
diameters are recorded. The absence and/or
closure of a great saphenous vein or small
saphenous vein from a previous surgical proPATIENT ASSESSMENT
cedure is noted. Areas of acute or chronic thrombosis,
Patients with CEAP Classification V or VI disease (ad- scarring or thickening, tortuosity, and reflux (incompevanced grades of venous insufficiency) often have both tence) are marked. If incompetent perforating veins are
superficial as well as deep system venous pathology.2 In found, their location and size are noted on the worksheet.
general, the most advanced venous hypertension is asso- The location and vein of origin of all varicose clusters
ciated with patients who have dual system involvement, are noted as well. The deep venous system is evaluated
concomitant venous thrombosis, or perforator incompe- for thrombosis, scarring, and reflux. When performed by
tence. It is the venous hypertension that causes the sub- an experienced technician, a detailed map of the venous
sequent chronic inflammation and eventual ulceration.
system is obtained with all relevant pathology marked.
A recent clinical trial has clearly showed underlying re- See Figure 1 for an example of a complete duplex scan
flux to be associated with the skin changes of chronic ve- from a vascular lab.
nous insufficiency.3 Results such as these have driven
The study must include an evaluation of the area in and
treatment toward intervention for the underlying reflux. around the ulcer bed, as frequently incompetent perfoSuccessful treatment of the reflux of the venous system rating veins are adjacent to or underneath the ulcer bed.
leads to decrease in the venous pressure of the leg, com- This requires that all compression wraps or Unna boots
monly described as the ambulatory venous pressure. A de- and local/topical ulcer dressings be removed at the time
crease in the ambulatory venous pressure is associated with of the scan. It is these authors’ practice to routinely perlocal improvement in the microcirculation of the skin and form duplex evaluations on ulcer patients the same day,
subcutaneous tissues, decreased pain, and decreased edema just before a patient’s second visit to the wound care cenin patients with chronic venous disease. 4–6
ter. This results in uninterrupted wound care and provides
the wound care center physician with the venous patholTHE VENOUS DUPLEX SCAN
ogy early in the treatment course, allowing for early reA comprehensive venous duplex scan of the lower ex- ferral to a vein specialist.
tremities should be performed for all patients with adThe test is performed with the patient is both supine
vanced venous disease, including patients with venous and standing positions. B-mode ultrasound imaging, color
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flow imaging, and Doppler spectral waveform analysis are
used to evaluate the venous system. The reverse Trendelenberg or standing position is an absolute requirement
for accurate diagnosis of reflux and incompetence of the
superficial and perforating systems.
The tests should be performed by a registered vascular
technologist (RVT) who has had additional specialty training in venous disease or who currently works with a vascular interventionalist who regularly treats venous disease.
It is best to establish a relationship with a venous specialist
and the vascular lab to provide patients with optimal care.
Duplex scan findings can sometimes be quite surprising,
given the patients history of previous surgeries or previous
venous problems. Nothing should be presumed about the
current venous pathology when evaluating a patient. For example, patients who have a history of great saphenous vein
(GSV) stripping have not always had their GSVs stripped.
Venous disease is progressive, just like arterial disease. 7–9
Pathology found and treated earlier in life does not guarantee
long-term absence of further venous pathology. In fact, recurrent ulceration frequently is accompanied by new venous
pathology, such as the development of new varicosities, new
locations of reflux, or new incompetent perforating veins.7–11
Based on the authors’ extensive experience, all patients
with a venous ulceration should be evaluated with a
comprehensive duplex scan upon initial presentation,
yearly thereafter, and upon any ulcer recurrence in the
future. All correctable venous pathology should be
treated immediately.
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EMERGING TREATMENT OPTIONS FOR VENOUS ULCERATION IN TODAY’S WOUND CARE PRACTICE
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Figure 1. Vascular lab venous report.
After a complete duplex scan performed by an experienced
technician, a detailed map of the venous system is obtained
with all relevant pathology marked.
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MINIMALLY INVASIVE TREATMENT
FOR VENOUS REFLUX
Minimally invasive procedures to treat valvular reflux
disease have changed treatment approaches to patients
with venous ulceration. Surgical treatment of reflux disease is now performed by almost all vein specialists under
local anesthesia in an office setting. Treatment is directed
at ablating, sclerosing, or closing incompetent veins in the
superficial or perforator systems responsible for the venous hypertension that delays ulcer healing.
Because these procedures are easy to perform, they can
be offered early in the treatment course of patients with
ulceration. The most common treatments are sclerosing,
thermal ablation via laser or radiofrequency energy, and
local surgical excision. (Radiofrequency thermal ablation
is the only one of these FDA-approved specifically for
treatment of incompetent perforator veins; laser ablation
is an offlabel use.) These procedures are performed under
ultrasound guidance with tumescent and topical anesthesia used for analgesia.
Expertise in the use of ultrasound and interpretation
of duplex images is essential for completion of these procedures. Once mastered, these procedures provide patients with minimally invasive, painless, incisionless,
office-based treatment for venous reflux disease.
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Endovenous ablation has revolutionized the care of patients with valvular reflux disease and venous ulceration,
and is becoming the standard of care. There is almost no
role for vein stripping procedures in modern venous
practice. The goal of treatment is to eliminate all sources
of venous hypertension caused by valvular reflux in the
superficial and perforator systems in the effected leg. Endovenous ablation is used routinely to treat incompetence
of the GSV, small saphenous vein (SSV), accessory saphenous vein (ASV), and perforating veins (PV). Once the
diagnosis is made, surgical treatment is outlined for each
patient and these procedures are routinely performed as
early as possible during the course of treatment.
The procedures do not interfere with the care of the
ulcer bed; in these authors’ opinions, they should be performed prior to ulcer healing, even if this requires treatment of an incompetent perforating vein under or
adjacent to an open ulceration. Ablations of PVs can be
safely performed through an open ulceration without
worry of infection or bacteremia.
IN-OFFICE TECHNIQUE
Patients are given topical anesthesia in the form of 2%
lidocaine cream and valium 5 mg before the procedure.
Lidocaine cream is placed on the area of the leg to be
EMERGING TREATMENT OPTIONS FOR VENOUS ULCERATION IN TODAY’S WOUND CARE PRACTICE
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clearly show the benefit of early intervention for superficial
and perforator venous reflux in patients with venous leg ulcers.15–18 The treatment approach has evolved to the current
practice of early treatment of superficial venous reflux disease in patients with venous ulceration. Not only does it enhance wound closure, but it helps prevent recurrence.
Cosmetic results are excellent; patient satisfaction is high.
With today’s treatment strategy, reducing the number of patients with chronic venous leg ulcers is a realistic goal. ■
References
1. Cullum N, Nelson E, Fletcher A, Sheldon T. Compression for venous
leg ulcers (review). Cochrane Database Syst Rev. 2001;(2):CD000265.
2. Eklof B, Rutherford R, Bergan J, et al. Revision of the CEAP classification for chronic venous disorders: Consensus statement. J Vasc
Surg. 2004;40(12):1248–1252
3. Labropoulos N, Kokkosis AA, Spentzouris G, Gasparis AP, Tassiopoulos AK. The distribution and significance of varicosities in the
saphenous trunks. J Vasc Surg. 2010;51(1):96–103.
4. Nicolaides AN, Hussein MK, Szendro G, et al. The relation of venous ulceration with ambulatory venous pressure measurements. J Vasc
Surg. 1993;17(2):414–419.
5. Welkie JF, Comerota AJ, Katz ML, et al. Hemodynamic deterioration in chronic venous disease. J Vasc Surg. 1992;16(5):733–740.
6. Nicolaides AN, Zukoski A, Lewis R, et al. Venous pressure measuremenets in venous problems. In: Bergan J, Yao J, eds. Surgery of the
Veins. Orlando, FL: Grune and Startton; 1985: 111–118.
7. Labropoulos N. The role of the distribution and anatomic extent of
reflux in the development of signs and symptoms in chronic venous
insufficiency. J Vasc Surgery. 1996;23(3):504–510.
8. van Rij AM, Hill G, Gray C, et. al. A prospective study of the fate
of venous leg perforators after varicose vein surgery. J Vasc Surgery.
2005;42(6):1156–1162.
9. van Rij AM, Jones GT, Hill GB, et. al. Neovascularization and recurrent varicose veins: more histologic and ultrasound evidence. J Vasc
Surgery. 2004;40(2):296–302.
10. Kostas T, Ioannou CV, Touloupakis E, et al. Recurrent varicose
veins after surgery: a new appraisal of a common and complex problem in vascular surgery. Eur J Vasc Endovasc Surg. 2004;27(3):275–282.
11. Labropoulos N, Leon L, Kwon S, et al. Study of the venous reflux
progression. J Vasc Surg. 2005;41(2):291–295.
12. Barwell JR, Davies CE, Deacon J, et al: Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR
study): randomised controlled trial. Lancet. 2004;363(9424):1854–1859.
13. Gohel MS, Barwell JR, Taylor M, et al. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial. BMJ.
2007;335(7610);83. Epub 2007 Jun 1.
14. vanGent W, Wijnand B, van Praag, et al. Conservative versus surgical treatment of venous leg ulcers: A prospective, randomized, multicenter trial. J Vasc Surg. 2006;44(3):563–571.
15. Nicolaides AN, Allegra C, Bergan J, et al. Management of chronic
venous disorders of the lower limbs: guidelines according to scientific
evidence. Int Angiol. 2008;27(1):1–59.
16. Poblete H, Elias S.Venous ulcers: new options in treatment: minimally
invasive vein surgery. J Amer Col Cert Wound Specialist. 2009;1(1):12–19.
17. Shafritz R, Lamb-Susca L, Graham AM. Comprehensive management for venous stasis ulcers. Surg Technol Int. 2008;17:72–76.
18. Khilnani NM, Grassi CJ, Kundu S, et al; Cardiovascular Interventional Radiological Society of Europe, American College of Phlebology, and Society of Interventional Radiology Standards of Practice
Committees. Multi-society consensus quality improvement guidelines
for the treatment of lower-extremity superficial venous insufficiency
with endovenous thermal ablation from the society of interventional
radiology, cardiovascular interventional radiological society of Europe,
American college of phlebology, and Canadian interventional radiology association. J Vasc Interv Radiol. 2010;21(1):14–31.
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treated 1 hour before the procedure. The procedure is
started with the placement of the patient in reverse Trendelenberg position on a Midmark or similar table.
Ultrasound imaging then is performed to identify the
location of the vein or veins to be ablated. Ultrasound imaging can be performed by the physician doing the procedure, but most commonly is performed by a technician.
The leg then is prepped with povidone-iodine. Additional
lidocaine or ethyl chloride spray then is used on the skin
at the entry point chosen for the start of the procedure.
With the patient in a reverse Trendelenberg position, an
ultrasound-guided venapuncture with a micropuncture
needle is performed on the vein to be ablated. A wire is
placed into the vein, followed by a sheath. A catheter or
laser fiber then is placed through the sheath and the tip of
the catheter is placed 2 cm distal to the saphenofemoral
junction, which is identified with ultrasound imaging.
Tumescent anesthesia then is delivered around the vein
being ablated under ultrasound guidance to provide additional analgesia and to compress the vein around the treatment catheter. The tumescent anesthesia used is a mixture
of 500 cc saline with 60 cc of 1:100,000 epinephrine and
5 cc of sodium bicarbonate solution. The patient then is
placed into a reverse Trendelenberg position, and the vein
then is treated with laser or radiofrequency energy.
Upon completion of the procedure, ultrasound and duplex imaging are performed to confirm closure of the vein
and to ensure that a deep venous thrombosis had not occurred at the saphenofemoral junction. Multiple veins can
be ablated in a single session if necessary, including PVs.
The entire procedure takes 30 minutes for a GSV, 20 minutes for a SSV, and 10 minutes for each perforator vein.
Post-procedure, topical silver dressings are applied to the
ulcer bed, and either elastic or inelastic compression is
reapplied as dictated by the wound care team. Alternately,
the patients can go immediately to the wound care center
for application of an appropriate compression dressing.
There are no incisions to heal; there is no post-procedure
pain. Skin puncture sites usually close within 48 hours. The
patient should continue the same level of activity as outlined by the wound care center. A follow-up ultrasound is
required in 48–72 hours to ensure adequate closure of the
vein and absence of a deep venous thrombosis.
Routine follow-up is required at the wound care center
until complete healing of the ulcer has occurred. An ultrasound is routinely performed at 6 months to evaluate the venous system. Ulcer healing may be expedited by performing
these procedures early in the treatment course, but the literature seems to suggest that the major advantage of these surgical procedures is the prevention of ulcer recurrence. 12–14
EARLY INTERVENTION IS KEY
Goals for intervention for venous disease are to improve
symptoms of chronic venous insufficiency, expedite wound
healing, and prevent recurrent ulceration. Multiple studies
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A New Algorithm for the Evaluation and Treatment
of Venous Leg Ulcer Patients in the Outpatient
Wound Care Clinic
CA
Robert A. Warriner III, MD, FACA, FCCP FCCWS, ABPM/UHM
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ower-extremity ulcers represent the single largest group of ulcers
presenting to outpatient wound care clinics for evaluation and
treatment, accounting for 70%–90% of all ulcers in some series.
In the United States, it is reported that 1.69% of the population 65
years and older are affected with 600,000 ulcers annually. Typical
cost of treatment are approximately $9,600 per episode, with high
recurrence rates common.1
Given the extremely high social and economic cost of venous leg
ulcers, it is incumbent on clinicians caring for these patients to have
a consistent approach to evaluation and treatment that takes into
account the most current evidence-based recommendations from
the literature.2–5 This article provides an algorithm for an evidencebased (level I evidence, grade of recommendation A or B) approach
to venous leg ulcer management, integrating definitive treatment
of the underlying venous disease into the typical outpatient approach to ulcer treatment (see Table 1).6–8
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CLINICAL PRESENTATION AND
DIFFERENTIAL DIAGNOSIS
The clinical presentation of venous leg ulceration can be
recurrent or long-standing. A history of previous deep vein
thrombosis (DVT) may or may not be present. Patient-reported symptoms include dull pain, heaviness, tiredness, restlessness, a feeling of tightness in the skin, and mild to
moderate edema. Symptoms often improve with elevation of
the legs, unless concomitant arterial disease is also present.
Physical findings include edema, hyper- or hypopigmentation, lipodermatosclerosis, weeping of the skin, and ulceration. The venous leg ulcer is irregularly shaped but with
well-defined borders and located in the supramalleolar area
(“gaiter” distribution), although they can be medial, lateral,
or posterior. The ulcer bed is often exudative, and bacterial
and fungal overgrowth on the wound and surrounding skin
surface is common.
The specific characteristics of the ulcer should be defined. An uncomplicated venous leg ulcer should not have
an eschar or exposed bone or tendon. Physical examination of the lower extremities should be performed with
the patient standing and supine, looking for evidence of
telangiectasias, superficial vein distention, and visible and
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Figure 1. Typical venous leg ulcer.
The specific characteristics of the ulcer should be
defined. An uncomplicated venous leg ulcer
should not have an eschar or exposed bone or
tendon. Upon physical examination, evidence of
telangiectasias, superficial vein distention, and visible and palpable varicosities should be explored.
palpable varicosities. A palpable thrill or a bruit over a
varicosity suggests the presence of an underlying ateriovenous fistula.
Color duplex ultrasound scanning utilizing an appropriate protocol visualizing the superficial and deep venous system with selective scanning of perforating veins
should be performed to 1) confirm the presence of deep
or superficial venous valvular incompetence and 2) identify incompetent perforators especially in the area adjacent to or beneath the ulcerations. In some cases, other
venous diagnostic studies (air plethysmography, CT or
MRI, contrast venography, or intravascular ultrasound)
may be warranted. 9
It must be remembered that superficial and deep venous
insufficiency leading to venous hypertension and ulceration can co-exist with other conditions that can produce
ulceration or affect healing, including peripheral arterial
disease (estimated to occur in 10%–25% of patients). At
minimum, an examination of peripheral pulses and an
ankle-brachial index (ABI) should be performed. Any abnormality should prompt further arterial assessment by
segmental pressure measurement and pulse volume recording. ABI <1.0 suggests some degree of underlying arterial
EMERGING TREATMENT OPTIONS FOR VENOUS ULCERATION IN TODAY’S WOUND CARE PRACTICE
Level of Evidence
• Level I: meta-analysis of multiple randomized clinical trials (RCTs)
or at least two RCTs supporting the intervention of the guideline
• Level II: less than Level I, but at least one RCT and at least significant clinical series or expert opinion papers with literature reviews
supporting the intervention
• Level III: suggestive data of proof of principle, but lacking sufficient
evidence such as meta-analysis, RCT, or multiple clinical series
Venous insufficiency
and hypertension
Arterial insufficiency
Cutaneous infections
Malignancy (primary)
Malignancy (secondary)
Malagnancy (manifestation
of distant malignancy)
Malignancy (acquired)
Drug reactions (especially
beta-lactams, penicillin,
sulfa drugs, nonsteroidal
anti-inflammatory drugs,
chemotherapeutic agents)
Inflammatory
Strength of Recommendation
Based on Robson and Barbul,6 Robson et al.,7 and Hopf et al.8
Ischemic ulcer
Bacterial, viral, fungal, protozoan
Squamous cell, basal cell carcinoma
Non-Hodgkin’s lymphoma,
T-cell lymphoma, metastatic
Myeloma, Waldenstrom’s
macroglobulinemia
Marjolin’s ulcer
Hematologic
Cyroglobulinemia,
cyrofibrinogenemia
Atrophe blanche
Connective tissue disease, systemic
lupus erythematosus, rheumatoid
arthritis, large and small vessel vasculitis, inflammatory bowel disease
Sickle cell, hypercoagulable states
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• Level A: strongly recommended/likely to be of benefit
• Level B: recommended
• Level C: recommended but not essential
• Level D: NOT recommended
Venous leg ulcer
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The level of evidence and strength of recommendation scheme
used in the algorithm is based upon the system used by the Wound
Healing Society in its chronic wounds clinical practice guidelines and
follows below.
Table 2. Differential Diagnosis of Lower-Extremity Ulcers*
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Table 1. Levels of Evidence and Grades of Reccomendation
TREATMENT OPTIONS
Treatment options fall broadly under three categories: compression, local wound care, and advanced technologies.A detailed
discussion of each of the interventions that may be of benefit in
the treatment of venous leg ulcers is beyond the scope of this article. However, the following have been demonstrated to be of
benefit in the effective treatment of venous leg ulcers:
1. compression,
2. debridement,
3. management of microbial burden,
4. moist ulcer care,
5. bioengineered skin substitutes and skin grafting, and
6. systemic agents.
Compression therapy is the core intervention in venous leg
ulcer treatment. Compression bandaging systems can be either short-stretch (typically multilayer or the traditional
Unna’s boot), producing high working pressures and best utilized in ambulatory patients; or long-stretch (typically single
layer or highly elastic), producing higher resting pressure and
best utilized in non-ambulatory patients. Although there is
substantial evidence for the effectiveness of compression over
no compression, within the categories of short-stretch and
long-stretch, there is little evidence supporting one intervention over another.16 Compression typically should provide
30–40 mm Hg at the ankle, although compression pressure
should be reduced in the setting of peripheral arterial disease
(ABI < 0.8–0.7, use reduced compression pressure; < 0.7,
compression relatively contraindicated).
In a recent review of the impact of debridement on venous
leg ulcer healing,17 ulcer surface area reduction was greater in
visits after debridement. Attention should be paid to removal
of all necrotic tissue, densely adherent slough and exudate, and
reshaping of the ulcer margins, eliminating epibole or margination of ulcer edge keratinocytes. Local ulcer care should
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disease. Guidelines for compression with an abnormal ABI
are provided below.
An atypical ulcer presentation or evidence of a contributory concomitant etiology on patient history should
prompt additional diagnostic studies. Additionally, any
lower-extremity ulcer presumed to be of venous etiology
that fails to make sufficient progress toward healing in the
first 4–6 weeks of therapy should prompt further directed
evaluation to determine if another primary or contributing
etiology is present.
Table 2 lists the differential diagnosis of lower-extremity
ulcers excluding diabetic foot ulcers. A full discussion of
the evaluation of each of these disorders is beyond the
scope of this article, but recent reviews have outlined diagnostic approaches including physical assessment, ulcer
biopsy, and ancillary studies when vasculitis or vasculopathic etiologies are suspected.10,11
*excluding diabetic foot ulcers
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EXPECTED HEALING OUTCOMES
Reported healing rates of venous leg ulcers treated with
compression therapy alone vary greatly; 49% of the venous
ulcers treated with compression therapy alone in the control
arm of a randomized clinical trial for a bioengineered skin
substitute healed in 24 weeks.12
Negative predictors for venous leg ulcer healing have
been identified in a large retrospective analysis and include
ulcer size ≥ 10 cm2, duration ≥ 12 months, history of venous ligation or venous stripping, history of hip or knee
replacement surgery, ABI of < 0.80, and the presence of
fibrin on more than 50% of the wound surface for 24-week
healing. 13,14 Data also suggest that a venous leg ulcer that
fails to decrease in size by 30% of its initial size over the
first 4 weeks of treatment has a 68% probability of failing
to heal within 24 weeks.15
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7UHDWHWLRORJ\
LGHQWLILHGE\
FRPSOHWHG
HYDOXDWLRQ
(malignancy, inflammatory,
infectious, etc.)
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•12 months, hx multiple
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IRUXOFHUKHDOLQJ
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YES
8OFHUKHDOHG"
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&RQVLGHU
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1. VLU: ulcer size •10cm2
2. 8OFHUGXUDWLRQ•12 months
3. Presence of PAD
4. Greater than 50% of ulcer
consisting of fibrous
connective tissue
1HJDWLYHSURJQRVWLF
LQGLFDWRUVSUHVHQW
&RQVLGHU
V\VWHPLF
DJHQWV
2SWLPL]HXOFHUEHG
1. Moisture balance, exudate
management
2. Protection of surrounding skin
3. Microbial balance
4. Address associated
inflammatory, vasculitic, microthrombitic processes
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resolve epibole, any
wound bed necrosis or
adherent slough or
exudate
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$FWLYHPRELOHSDWLHQWuse
multi-layer (elastic long-stretch,
inelastic short-stretch)
compression bandage or
stockings
,PPRELOHIL[HGDQNOHSDWLHQW
use multi-layer elastic longstretch compression bandage
&RPSUHVVLRQ
$OJRULWKPIRU9HQRXV/HJ8OFHU0DQDJHPHQW
,QFOXGLQJ0DQDJHPHQWRI8QGHUO\LQJ9HQRXV'LVHDVH
1. Treatment of venous insufficiency:
Saphenous reflux (± deep system reflux)...endovenous
ablation ± phlebectomy
Perforator incompetence...percutaneous ablation of perforators
Deep system reflux alone...consider valve transplant
2. Systemic agents with Level 1 Grade A/B evidence include pentoxifylline and diosminhesperidin (flavinoid)
5HIHUIRUIXUWKHU
DVVHVVPHQWDQGWUHDWPHQW
RIDUWHULDOGLVHDVH
(return to algorithm as
indicated)
Abnormal
1. Pulse examination
2. Ankle:brachial pressure index
(ABI)
3. Toe pressure, skin perfusion
pressure (SPP), transcutaneous
PO2 if indicated
$VVHVVIRUDUWHULDOGLVHDVH
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9HQRXV
'LVHDVH
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1. Venous duplex ultrasound of
superficial and deep venous systems,
directed perforator evaluation
2. Other tests as indicated (air
plehtysmography, CT, MRI, venous
angiogram
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3DWLHQWZLWKORZHU
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EMERGING TREATMENT OPTIONS FOR VENOUS ULCERATION IN TODAY’S WOUND CARE PRACTICE
Figure 2. Algorithm.
EMERGING TREATMENT OPTIONS FOR VENOUS ULCERATION IN TODAY’S WOUND CARE PRACTICE
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References
1. Sen CK, Gordillo GM, Roy S, et al. Human skin wounds: A major and
snowballing threat to public health and the economy. Wound Rep Reg.
2009;17(6):763–771.
2. Robson MC, Cooper DM, Aslam R, et al. Guidelines for the treatment
of venous ulcers. Wound Rep Reg. 2006;14(6):649–662.
3. DePalma RG. 49. A treatment algorithm for venous ulcer: current
guidelines. In: Gloviczki P, ed. Handbook of Venous Disorderes, 3rd ed,
Guidelines of the American Venous Forum. London: Edward Arnold Ltc.,
2009: pp 545–552.
4. O’Donnell TF. 41. Local treatment of venous ulcers. In: Gloviczki P, ed.
Handbook of Venous Disorderes, 3rd ed, Guidelines of the American Venous
Forum. London: Edward Arnold Ltc.; 2009: 457–471.
5. Moneta GL, Partsch H. 30. Compression therapy for venous ulceration,
In: Gloviczki P, ed. Handbook of Venous Disorders, 3rd ed, Guidelines of the
American Venous Forum. London, UK: Edward Arnold Ltc.; 2009: 328–358.
6. Robson MC, Barbul A. Guidelines for best care of chronic wounds.
Wound Rep Regen. 2006;14(6):647–648.
7. Robson MC, Cooper DM, Aslam R, et al. Guidelines for the treatment
of venous ulcers. Wound Rep Regen. 2006;14(6):649–662.
8. Hopf HW, Ueno C, Aslam R, et al. Guidelines for the treatment of arterial insufficiency ulcers. Wound Rep Regen. 2006;14(6):693–710.
9. McClafferty RB, Lambert AD. 29. Diagnostic algorithm for telangiectasias, varicose veins and venous ulcers: current guidelines. In: Gloviczki P,
ed. Handbook of Venous Disorderes, 3rd ed, Guidelines of the American Venous
Forum. London, UK: Edward Arnold Ltc.; 2009: 342–347.
10. Panuncialman J, Falanga V. Basic approach to inflammatory ulcers. Dermatologic Ther. 2006;19(6):365–376.
11. Russell JP, Gibson, LE. Primary cutaneous small vessel vasculitis: approach to diagnosis and treatment. International J Dermatol. 2006;45(1):3–13.
12. Falanga V, Margolis D, Alvarez O, et al. Rapid healing of venous ulcers
and lack of clinical rejection with an allogeneic cultured human skin
equivalent. Arch Dermatol 1998; 134:293–300.
13. Margolis DJ, Allen-Taylor L, Hoffstad O, Berlin JA. The accuracy of venous leg ulcer prognostic models in a wound care system. Wound Rep
Regen. 2004;12(2):163–168.
14. Margolis DG, Berlin JA, Strom BL. Risk factors associated with the
failure of a venous leg ulcer to heal. Arch Dermatol. 1999;135(8):920–926.
15. Kantor J, Margolis DJ. A multicenter study of percentage change in venous leg ulcer area as a prognostic index of healing at 24 weeks. Br J Dermatol. 2000;142(5):960–964.
16. O’Meara S, Tierney J, Cullum N, et al. Four layer bandage compared
with short stretch bandage for venous leg ulcers: systematic review and
meta-analysis of randomized controlled trials with data from individual patients. Br Med J. 2009;338:b1344.
17. Cardinal M, Eisenbud DE, Armstrong DG, et al. Serial surgical debridement: A retrospective study on clinical outcomes in chronic lower extremity wounds. Wound Rep Reg. 2009;17(3):306–311.
18. Sibbald RG, Orsted H, Schultz GS, et al. Preparing the wound bed
2003: focus on infection and inflammation. Ostomy Wound Manage.
2003;49(11):24–51
19. Falanga V, Margolis D, Alvarez O, et al. Rapid healing of venous ulcers
and lack of clinical rejection with an allogeneic cultured human skin equivalent. Human Skin Equivalent Investigators Group. Arch Dermatol.
1998;134(3):293–300.
20. Jull A, Waters J, Arroll B. Pentoxifylline for treating venous leg ulcers.
The Cochrane Database of Systematic Reviews. Issue 1. The Cochrane
Collaboration: John Wiley & Sons Ltd.; 2002.
21. Coleridge-Smith P, Lok C, Ramelet AA.Venous leg ulcer: a metaanalysis of adjunctive therapy with micronized purified flavonoid fraction.
Eur J Vasc Endovasc Surg. 2005;30(2):198–208.
22. Khilnani NM, Grassi CJ, Kundu S, et al. Multi-society consensus
quality improvement guidelines for the treatment of lower-extremity
superficial venous insufficiency with endovenous thermal ablation from
the society of interventional radiology, cardiovascular interventional radiological society of Europe, American college of phlebology, and
Canadian interventional radiology association. J Vasc Interv Radiol.
2010;21(1):14–31.
23. Gloviczki P, Yao J (eds.). Handbook of venous disorders: Guidelines of the
American Venous Forum, 3rd Edition. New York, NY: Oxford University Press
USA; 2009.
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maintain an appropriately moist ulcer base while removing
excess exudate from the ulcer and protecting the surrounding
skin from maceration.The product chosen also should reduce
pain during application and at removal. There is no evidence
that clearly favors one topical ulcer care product over another,
provided these conditions are met. Since venous leg ulcers are
frequently colonized with multiple bacterial species and fungal
organisms, careful cleansing at each dressing change and the
use of a short course of a topical antimicrobial wound dressing
also may be beneficial.18 When there is clinical evidence of
cellulitis, systemic antibiotic therapy should be administered.
Facilitation of re-epithelialization once edema and exudate
control have been achieved and microbial balance obtained may
be achieved by the application of a bioengineered skin substitute19 or by split-thickness skin grafting.These interventions may
be of greatest value relative to cost in the ulcer presenting with
the negative prognostic indicators previously described present
at the time of initial evaluation, or when a positive predictor
healing rate is not observed during the first 4–6 weeks of appropriate compression therapy and local wound care.
Finally, two systemic agents, pentoxifylline20 and diosminhesperidin, a micronized purified flavonoid fraction,21 have
been shown in randomized controlled clinical trials to accelerate ulcer healing and should be considered as adjunctive
therapy, particularly in the patient identified as having a high
risk for initial ulcer healing failure or ulcer recurrence.
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INTEGRATING VENOUS DISEASE MANAGEMENT
FOR TREATMENT, PREVENTION
Recent reviews of multiple RCTs discussed elsewhere in this
supplement have demonstrated the value of endovascular treatment of the underlying venous pathophysiology in both reducing
ulcer recurrence rates and possibly accelerating ulcer healing rates
in circumstances where subulcer perforator ablation can be
achieved.These advances in the management of superficial venous
insufficiency, when applied in concert with optimal local treatment of the venous leg ulcer, can change the paradigm for both
resolution of recalcitrant ulcers and reduction in recurrence rates.
The recently published Multi-society Consensus Quality Improvement Guidelines for the Treatment of Lower-extremity Superficial
Venous Insufficiency with Endovenous Thermal Ablation from the Society of Interventional Radiology, Cardiovascular Interventional Radiological Society of Europe, American College of Phlebology, and
Canadian Interventional Radiology Association 22 and the American
Venous Forum’s Handbook of Venous Disorders23 have been integrated into a traditional algorithm for the outpatient management of venous leg ulceration (see Figure 2).
Direct treatment of venous insufficiency has been integrated
into the algorithm in three circumstances: 1) during the initial
management of the ulcer presenting with one or more risk factors for poor healing and demonstrated treatable venous disease
on duplex ultrasonography; 2) in the ulcer that has failed to respond to appropriate therapy with or without identifiable negative predictors; and 3) after resolution of the ulcer to reduce
the rate of ulcer recurrence. ■
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