Given the common and chronic nature of venous stasis ulcers, these authors offer salient diagnostic insights, keys to selecting appropriate wound care dressings and a guide to choosing optimal compression modalities. They also emphasize the importance of patient education in reducing the risk of recurrence.
As lower extremity specialists, we are not all trained or equipped to focus our attention on the treatment of venous leg ulcers. This is partly due to the integrated medical systems required to manage these patients with significant, complex medical comorbidities. Another possible factor is economic constraints imposed by inadequate reimbursement strategies that are “out of synchrony with government approved standards of care.”1
However, the scope of the problem is greater than we may realize as primary chronic venous insufficiency is “widespread in the population.”2 Finlayson and co-workers recently noted that approximately 40 to 50 percent of the adult population has some degree of chronic venous insufficiency with 1 to 2 percent progressing on to ulceration.3
Venous leg ulcers typically develop along the medial distal ankle, affecting over 2.5 million people per year in the United States with 70 to 90 percent becoming chronic and potentially very painful.4 Treatment requires an average of six to 12 months to heal completely and 70 percent recur within five years of closure.5 Recurrence is associated with loss of an estimated 2 million workdays and decreased quality of life.2 The cost for treating patients is burdensome with chronic venous ulcer treatment costing an estimated $3 billion per year in the U.S.6,7
Podiatrists are in an ideal position to help address this clinical issue as part of the limb preservation effort. It is essential to understand the pathologic mechanisms causing the ulcers in order to develop the most evidence-based treatment plan. However, it is helpful to understand the challenges inherent in the lack of standardized diagnostic testing for chronic venous insufficiency. Likewise, it is critical to understand the factors that place patients at risk for progression to ulceration.2
Recently, the National Guideline Clearinghouse accepted a content validated venous ulcer guideline developed by the Association for Advanced Wound Care (AAWC).1 This guideline represents a great step forward in support of our efforts to treat patients with chronic venous insufficiency. The AAWC venous leg ulcer guideline points out that there are multiple economic disincentives to providing optimal care.
Due to the previous lack of a validated guideline, one issue is the inconsistent interpretation of federal regulations, which may lead to inconsistent reimbursement. The economic downturn, which has become as chronic as some of our patients’ venous leg ulcers, serves to put evidence-based practices even further out of reach for many.
What can we do in our practice to help those who are not well insured and are not able to pay out of pocket for treatments that improve outcomes? Are we forced to watch our patients “settle” for what the guideline describes as “substandard care with gauze without compression that pushes them to associated pain, increased infection rates and protracted healing time”?1 For these patients, we can best spend our time by teaching the importance of the basics, such as compression, moist wound healing and elevation. We can also suggest lower priced materials such as Unna boots with cohesive wrap, which patients can change frequently with the aid of a family member.
What can we do to address prevention, psychosocial issues, recurrence prevention and treatment? Although more clinical evidence is necessary, recent work by Finlayson and colleagues suggests that psychosocial factors of low levels of social support and self-efficacy are “significantly associated with a greater risk of recurring venous leg ulcers.”3 Accordingly, we should encourage the engagement of friends, family and other sources of support.
Essential Diagnostic Considerations
According to the Clinical, Etiology, Anatomy, Pathophysiologic (CEAP) Classification, a venous type ulcer is one of six different types (see “A Pertinent Overview Of The CEAP Classification” at left).8
Category 1 shows telangiectasias or reticular veins like spider veins.
Category 2 will show varicose veins.
Category 3 will start showing varicose veins along with leg swelling.
Category 4 will show evidence of venous stasis skin changes.
Category 5 reflects skin changes in conjunction with healed ulcerations.
Category 6 describes skin changes in association with active ulceration.
Patients in categories 5 and 6 will most likely need wound care management whereas those in categories 1 to 4 will require long-term preventive treatment. Note that if chronic venous insufficiency goes untreated, it might result in secondary lymphedema, which may further complicate venous ulcer management.
The revised CEAP classification of chronic venous disease defines a venous ulcer as a full thickness defect of skin, most frequently in the ankle region (usually in the gaiter region), which fails to heal spontaneously and is sustained by chronic venous disease.8
The exact etiology of venous ulceration is unknown. However, the mechanism of venous ulcers is theoretically due to the incompetence of the valves causing intraluminal pressures to increase. When venous hypertension is present, blood does not pump as effectively in or out of the area and pools accordingly. Venous hypertension may also stretch veins and allow blood proteins to leak into the extravascular space, isolating extracellular matrix molecules and growth factors, and preventing them from helping to heal the wound.9 Leakage of fibrinogen from veins as well as deficiencies in fibrinolysis may also cause fibrin to build up around the vessels, preventing oxygen and nutrients from reaching cells.9 This improper functioning of vein pressure results in transudation of inflammatory mediators into the subcutaneous tissues of the lower extremity and subsequent breakdown of the tissue including the skin.
Symptoms may include mild to severe edema of leg as well as sensations of fatigue and heaviness with burning or itching. It is helpful to let patients know that sufficient reduction of edema can offer partial relief, if not full relief, of the aforementioned symptoms. There may also be a rash, redness, brown discoloration of hemosiderin staining, lipodermatosclerotic changes as well as xerosis with thick hyperkeratotic plaques. These shallow lesions occur on the medial lower extremity just above the ankle where venous pressure is greatest due to the presence of large communicating veins.
The base of a venous ulcer is usually red and may be covered with yellow fibrous tissue. If the venous ulcer is infected, there may be a green or yellow discharge. The drainage amount can vary from minimal to moderate. The borders of a venous ulcer are usually irregularly shaped and the surrounding skin is often discolored and swollen. The ulcer may even feel warm or hot. The skin may appear shiny and tight, depending on the amount of edema. The skin may also have brown or purple discoloration, known as “stasis skin changes,” about the lower leg.
Venous stasis ulcers are common in patients who have a history of leg swelling, longstanding varicose veins or a history of blood clots in either the superficial or the deep veins of the legs. Ulcers may affect one or both legs.
The differential diagnosis for the venous stasis ulcer can include ischemic ulceration, pyoderma gangrenosum, lymphedema, trauma, neuropathic ulceration and cellulitis (see “What Are The Differential Diagnoses For Venous Leg Ulcers?” at right).10 Complete assessment of the patient’s medical history is critical as treating the wrong etiology is a common reason for prolonged ulcerations with a poor outcome. When it comes to patients with suspected venous ulcerations, one should ensure a thorough clinical history, physical examination, appropriate laboratory tests and a hemodynamic assessment. Doing so will enable one to identify both the underlying cause and any associated diseases, and influence decisions about prognosis, referral, investigation and management.
Also keep in mind that if the ulcer persists beyond 12 weeks despite the best evidence-based treatment efforts, one must take a biopsy to rule out carcinogenic conversion or any suspected differential diagnoses.
The venous duplex test is helpful in assessing the superficial and deep venous system of the lower extremity to determine the presence or absence of deep or superficial vein thrombosis. We commonly use the venous duplex test to diagnose chronic venous insufficiency. However, the venous reflux test is more specific than the duplex test since this will show the dysfunctional valve system. Additional diagnostic tools for chronic venous insufficiency include computed tomography (CT), which is not very cost effective. It is important to order ankle brachial indices (ABI) not for diagnostic purposes but rather to determine safe levels of compression therapy. However, the gold standard for diagnosing chronic venous insufficiency is venography. We highly recommend consulting a vascular surgeon early in the treatment process.
Essential Insights On Treatment
The most important goal for the treatment of venous leg ulcers is long-term edema control. The revised validated venous stasis ulcer guideline by AAWC recommends delivery of evidence-based care by qualified professionals using a multidisciplinary team for effective venous ulcer treatment.1 Therefore, it is paramount to get a thorough history, physical examination, and consult the proper team members for development of a collaborative treatment strategy. We believe it is important to consult vascular surgery at the beginning stages of treatment.
Treatment depends on the aforementioned CEAP classification. For patients in Categories 1-4, we emphasize conservative treatment with bed rest, leg elevation and compression stockings.
In addition, one may consider treatments provided by vascular surgeons. These treatments include: injecting a sclerosing agent directly into veins; superficial and perforating vein ablation; deep vein reconstruction; and subfascial endoscopic perforator vein surgery combined with superficial vein ligation. If an ulcer is present, we recommend the aforementioned conservative treatments and adding local wound care to keep the wound site clean and non-infected. Therefore, cleansing the wound with each dressing change is important.
Clinicians can determine the appropriate type of dressing for ulcers by the appearance of tissue type on the ulcer base (see “How To Select The Optimal Dressing For Venous Ulcers” at left).11
Depending on the wound type and drainage amount, there are a plethora of dressings and therapies from which to choose. These include hydrogels, alginate dressings, collagen wound dressings, debriding agents such as Santyl (Healthpoint) and Accuzyme (Healthpoint), and antimicrobial dressings with silver- or cell-based therapies. Other options include platelet rich plasma (PRP), platelet-derived growth factor (PDGF), low frequency ultrasound therapy (MIST, Celleration) with composite dressings, negative pressure wound therapy (NPWT) and synthetic skin substitutes. All wound care therapy programs must include compression therapy to be more effective.
There are many different types of composite/compression dressings. However, there is no international guideline for the proper application of compression treatments. In a 2007 article, the World Union of Wound Healing Societies proposed a management plan to assist clinical decision making in the use of compression therapy for venous leg ulcers.12 They explained the diagnosis of venous leg ulcers, treatment options and possible outcomes from the treatment (download “Key Considerations For Compression Therapy In The Treatment Of Venous Leg Ulcers” at http://podiatrytoday.com/files/PT_78.pdf ), which can initially guide the type of compression dressing one uses.
In general, we apply multilayer compression wraps from the toes or foot to the area below the knee. Different types of compression layers on the market include four-layer bandages, double-layer tubular elastic bandages, compression stockings or short stretch compression.
For clinical purposes, the level of compression dressing indicated depends on the patient’s comfort level, the amount of edema and the results of ABI testing. One should apply compression wraps with caution on the patient who has an ABI below 0.75. Never place compression wraps on a patient with an ABI lower than 0.5 or those who develop a sudden increase of edema on both lower extremities. These two clinical scenarios require consultation with a cardiologist or vascular surgeon for further evaluation for cardiac failure or arterial insufficiency.
If the ABI is between 0.9 and 1.25, the patient can likely tolerate treatment with a four-layer compression or long stretch compression wrap. When the patient has an ABI between 0.75 and 0.9, we recommend single layer compression comprised of cast padding and Coban in spiral formation. However, the use of compression wrap remains dependent on the patient’s comfort level and degree of leg edema.
We always recommend starting with single layer compression and gradually increasing the compression as the patient tolerates and as edema allows. In addition, the frequency of dressing changes depends on drainage volume. If patients have heavy exudate, they should change dressings more frequently. Dressing changes can initially occur daily and then gradually decrease to weekly changes depending on the degree of edema and amount of drainage. One can use steroids, either oral or topical, for short periods of time to help decrease exudate.
Sometimes patients can wear Unna boots if their skin shows any type of dermatitis. Unna boots are rolled bandages that contain a combination of calamine lotion, glycerin, zinc oxide and gelatin. Calamine lotion can sometimes provide a soothing effect and it works well on the patient who has a burning sensation. However, the Unna boot itself does not provide any control of edema. Therefore, a compression wrap would still be required.
It is important during treatment to consider the patient’s socioeconomic situation and possibly utilize a social worker to assist the patient in the frequent clinic visits that may be required. If a social worker is not available at the facility, arranging visits from the Visiting Nurse Associations of America may be another option. If nursing visits will be part of the treatment plan and follow-up, make sure dressing change orders are very clear and well communicated with the nurse. This plays an important role in treatment outcomes.
Bolton and colleagues recommended that if the ulcer size does not reduce 40 percent within three weeks, the patient may require adjunctive therapies.5 These therapies may include IV or PO antibiotics to treat infection, additional drugs like anti-platelet or anti-clotting medication or vascular surgical options.
Selecting The Appropriate Compression Stockings
Once the ulcer has healed and edema is under control, then one needs to proceed to the recovery phase of treatment. This typically involves a patient centered self-care plan. One option is compression stockings to help keep blood from pooling in the feet and calf.
Compression support hose have different pressure levels. Light compression socks will have 10 to 15 mmHg compression and are good for treating varicose veins, which fall under CEAP Category 2.8 Clinicians may employ medium compression hose, which have up to 20 to 30 mmHg compression, to treat severe varicose veins, chronic venous hypertension and to help prevent venous leg ulcers.
High compression hose have a pressure range of 25 to 35 mmHg compression and are useful for those with severe edema, who require prevention of venous leg ulcers.
Selecting correct compression hose often requires a degree of trial and error. However, it is safe to start the patient who shows hemosiderin changes and a history of venous ulceration with a 20 to 30 mmHg gradient compression hose and add more compression if the patient’s edema is not adequately controlled. For example, one can use compression pump treatment in conjunction with the stocking or utilize CircAid® products in combination with stockings.
Patients with severe physical limitations may require additional accessory devices such as donning devices or stocking sleeves. It will be important to utilize either family members or other personal assistants to ensure timely and consistent implementation of the treatment plan.
The table “What You Should Know About Elastic And Inelastic Compression Systems” (at left) provides an overview of some of the basic compression dressings.
What You Should Know About Psychosocial Factors And The Recurrence Of Venous Leg Ulcers
It is important to recognize the patient’s psychosocial factors during venous leg ulcer treatment. In a prospective study, Finlayson and colleagues collected data from 80 patients with a previous history of healed venous ulceration and identified the relationship among preventive activities, psychosocial factors and ulcer recurrence.3 They discovered that leg elevation, compression hosiery, high levels of self treatment efficacy and strong social support helped prevent recurrence. The study shows that median time to recurrence was 27 weeks.
The study demonstrated that patients who elevated the leg at least one hour per day for six days a week had less chance of ulcer recurrence.3 Study authors also found that 34 percent of patients were diagnosed with depression when they had ulcer recurrence. High body mass index and low nutritional value will delay the healing process. Overall, psychosocial issues will increase the chance of recurrence by impacting on self-care activities of patients.
Case Study: When A Patient Presents With Longstanding Venous Stasis Ulcers
A 45-year-old Caucasian male presented with a medical history of liver disease, tuberculosis, substance abuse and depression. The vascular clinic referred him for chronic, non-healing venous stasis ulcers of six years’ duration. The ulcerations began as trauma on both of his legs from broken glass while crawling through a window.
The patient self treated his wounds at home for a couple of years. However, after not seeing any progress, he decided to see a physician at Boston Medical Center. The patient went to the vascular clinic for three years. During this time, he had venous reflux tests, which revealed incompetent superficial and deep venous systems on both legs. His ABI was 1.0 bilaterally. The patient was using a four-layer compression wrap and had multiple treatments of antibiotic therapy prior to our clinic consultation. Also, during treatment with the vascular team, the patient underwent a right saphenous ablation procedure on the right leg and had intraoperative debridement of the wound sites.
On our initial visit, the patient admitted to smoking for 25 years. The physical examination revealed ulcers on the anterior surface of both legs. There was a 2 cm by 3 cm ulcer on the right leg and a 9.5 cm by 6 cm ulcer on the left leg. The ulcers were deep (approximately 3 to 5 mm) without exposed tendon or bone. The base of the ulcers was 80 percent fibrotic and 20 percent pink granulated tissue. There was no sign of infection and no odor, but there was mild edema. The surrounding periwound tissue had localized erythema, which was more from inflammation than infection.
We debrided the ulcers to subcutaneous tissue. We provided standard of care treatment with the exception of soaking the ulcers for 15 minutes in a silver solution prior to using the compression wrap with PO antibiotics for 10 days.
We also reinforced the necessity to quit smoking and educated the patient to elevate his leg above his heart any time he is resting.
Originally, the patient’s ulcers had significant exudate so he came to our clinic three times a week for dressing changes. Then as the base of the wounds evolved into more red granulated tissue and exudate was under control, we reduced his dressing changes to twice per week. Once the base of the wounds filled with granulated tissue, we applied a skin substitute in conjunction with compression wrap after silver solution soaking.
The right leg ulcer healed within two months and we prescribed 20 to 30 mmHg compression hose to control edema. The left leg ulcer is still open but diminished to 5 cm by 3 cm. The patient has cut down on smoking. He is committed to stopping smoking, elevating his leg at least one hour per day and wearing a compression stocking on the healed ulcer leg every day. He has not been using recreational drugs or pain medication for some time now.
Keys To Prevention And Patient Education
It is vital to individualize any treatment, based on the patient’s health, medical condition, psychological status and socioeconomic status as well as the patient’s physical ability to care for the wound. It is important to apply sufficient pressure to improve the chronic venous insufficiency during the treatment period. If needed, treatments should begin with antibiotics for infection or anti-platelet or anti-clotting medications to prevent a blood clot.
Patients need to understand the treatment plan, the goals of treatment and how the patient and clinician are going to work together to achieve the stated goals. One needs to establish and maintain trust if the treatment is to be effective. It is important patients understand that venous leg ulcers often recur and that treatment is an ongoing process of preventing future ulcers and managing acute ulcerations.
As healthcare providers, it is important to teach patients to monitor their wounds, check for complications often and maintain a daily self-care regimen. This regimen should include the following points.
• Wash feet daily and check for sores, calluses, blisters, injury or infection. Notify your doctor of any such condition.
• Keep the wound and dressing clean and dry, changing the dressing as directed.
• Wear comfortable shoes that do not restrict circulation.
• Maintain regular physical activity. This should include an exercise program advised by a physician or physical therapist. Low-impact exercise, such as walking 30 minutes per day and/or stretching, would be helpful.
• Stop smoking.
• Eat a well-balanced, heart healthy (low salt, low fat) diet. Following such a diet can reduce blood pressure, blood cholesterol and blood sugar levels.
• Maintain a healthy weight.
• Use compression socks if appropriate.
• Elevate legs one hour daily
Lastly, it is important to communicate with different specialties for input and advice on the treatment plan. This will reduce the long-term cost and will produce a more effective result for the patient.
Regardless of the etiology of venous ulcerations, it is fundamentally necessary to develop a protocol for clinical practice. One must adapt any preventive method to the patient’s socioeconomic needs and abilities if it is to be effective. Clinicians need to balance the patient’s needs and desires as they pertain to quality of life issues and associated economic resources. Ultimately, the success or failure of treatment will rely on the trust and teamwork that develops between patients and providers.
Dr. Park is a Research Fellow in Limb Preservation and Wound Healing in the Department of Surgery at the Boston University School of Medicine and Boston Medical Center.
Dr. Allen is the Chief Podiatry Surgical Resident at the Atlanta Veterans Affairs Medical Center in Decatur, Ga.
Dr. Gu is an International Scholar in Limb Preservation and Wound Healing in the Department of Surgery at the Boston University School of Medicine and Boston Medical Center. He is also a General Surgeon at the Jinling Hospital at the Nanjing University School of Medicine in Nanjing, China.
Dr. Driver is an Associate Professor of Surgery and the Director of Clinical Research, Limb Preservation and Wound Healing at the Boston University Medical Campus and the Boston University School of Medicine. She is also the Director of the Research Fellowship and International Scholars Program at those institutions.
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Editor’s note: For further reading, see “How To Manage Venous Stasis Ulcerations” in the May 2007 issue of Podiatry Today, “Treating Venous Stasis Ulcers In The Lower Extremity” in the October 2004 issue or “Vascular Intervention In Difficult Wounds” in the July 2002 issue.