by Michael Cioroiu, MD., FACS; Foram Udeshi DPM; Vinit Shah DPM

Chronic venous ulcers—also known as stasis ulcers or venous leg ulcers (VLU)—likely represent the majority of chronic wounds seen in a typical wound care clinic. As great as 70 percent of lower extremity wounds are venous with a recurrence rate up to 90 percent. In our wound center practice, for instance, about 20 percent to 25 percent of chronic wounds seen in a typical month are venous stasis ulcers.

Chronic venous insufficiency affects up to 2.5 million people per year in the United States and is the leading cause of lower extremity ulceration. There are about one million people in the United States living with leg ulcers, out of which 50-70 percent are venous in nature. In 2015, according to the Medicare Evidence Development and Coverage Advisory Committee, there were 59,116 venous leg ulcers documented in the US Wound Registry in about 19,151 patients. In the US, over $14.9 billion dollars are spent on the treatment of venous ulcer related issues. Although the condition is not fatal to patients’ health, it drastically impairs quality of life and can often result in repeated hospitalizations.^{1, 9}

Chronic venous wounds (stuck in the inflammatory phase), usually occur due to venous hypertension caused by venous obstruction or reflux or both. Venous ulcers are usually located along the medial aspect of the lower extremity, are irregularly shaped with well-defined borders. An adequate venous valvular system typically prevents regurgitation and superficial capillaries and veins from increases in venous pressure. Valvular incompetence can cause an increase in venous pressure, which in turn dilates and elongates the veins and venules, increasing permeability and leakage of plasma and erythrocytes into the surrounding tissue.^7,8,9 This, in turn, leads to the development of trauma to the tissue, inflammation thus leading to an ulceration.¹

An assessment of venous ulcers should be carefully done, and it is always important to remember that 25-30 percent of cases have an associated arterial component. Any advanced wound center should have a developed clear and proven clinical pathway for proper treatment. The literature provides many guidelines, some from vascular societies, others from wound care organization—in essence, they all recommend classical well-known principles such as debridement, control of edema and peri-wound skin protection, and the importance of a clean environment for the wound bed for proper epithelialization using adequate dressings.

We’ll try to address each one of these principles separately, based on our experience as well as the available guidelines mentioned above.

Assessing Etiology

By chronic, we mean any wound that did not heal in approximately six weeks with maximal wound care. Every time a patient presents with a chronic wound of the lower extremity, we first try to assess the proper etiology. A complex clinical examination is first done with proper indications for vascular lab testing and any other further minimally invasive examinations, all documented in a wound care specific EMR.

Once the diagnosis of venous ulcer has been made, proper wound care is started according to our clinical guidelines. First, a wound debridement under topical anesthesia or sedation is done, after which a deep tissue culture is taken. The debridement could be surgical, mechanical, or ultrasonic according to the size of the wound, the amount of bioburden (bacterial colonization, fibrin, and proteolytic enzymes) or the clinician’s preference.

The necessity of deep tissue culture is still debatable. Generally in chronic wounds, including venous ulcers, it’s important to understand the differences between contamination, colonization, critical colonization and frank infection.¹¹

The clinical guidelines from the Society of Vascular Surgery place wound cultures at a Grade 2C, arguing against tissue culture unless there are obvious clinical signs of infection.9 However, our experience suggests that an initial wound culture could be helpful later in treatment if the wound response to healing is not satisfactory.

Periwound erythema with streaking is consistent with cellulitis and additional clinical features such as tenderness, warmth, increase in size of the ulcer and drainage, elevated WBC, positive constitutional symptoms are also signs of infection.

An increase in wound exudate, with the exudate becoming thicker, suggests a transition from wound colonization to infection.¹² Such clinical signs warrant obtaining a wound culture to determine the appropriate antibiotic choice if an infection is confirmed. The most common organisms in venous ulcers include gram positive organisms such as Staphylococcus and Streptococcus and gram-negative organisms such as pseudomonas and enterobacter.¹ Wounds can be treated with topical antimicrobials and if the infection is recurrent, there is an indication for oral antibiotics based on the appearance of the wound. Antimicrobial agents such as Bactroban, gentamicin, triple antibiotic, and erythromycin are several topical treatment options for venous ulcers and can be used individually or in conjunction with an absorbent dressing depending on the wound appearance, odor and culture results.

Debridement

One of the initial goals of wound care is wound bed preparation, which involves (as mentioned above) debridement, control of wound drainage, and management of bioburden. Debridement, regardless of the method, should be done weekly. The literature shows significant evidence that it promotes healing, and the level of evidence is Grade 1B.⁹ In addition, studies published by different wound societies mention the reoccurrence of bioburden 24-48 hours after debridement, which thereby rather encourages the use of weekly debridement.

Periwound Skin Assessment

Periwound skin assessment is critical towards treating the ulcer as a whole. Periwound skin is described as being intact or with dermatitis. In addition, overall skin integrity along the lower extremity with a wound can be categorized as dry and scaly, moist, or macerated.

Drainage is usually increased in venous ulcers and it is always assessed in addition to the wound appearance.

Stasis dermatitis is a common complication of venous ulcers (VLU) and appears xerotic, erythematous, with scaling and crusting. It can be pruritic and may progress to weeping.

It is important to address the peri-wound in the treatment plan to ensure appropriate healing of the lower extremity. Dermatitis is normally treated with a topical anti-inflammatory, anti-itch cream and a skin moisturizer to reduce pruritus, edema, erythema and xerosis. It’s been mentioned that patients experiencing severe pruritus in the peri-wound area have poor compliance keeping dressings in place, making it all the more important to address.

Wound Dressings

Primary and secondary dressings are usually a key component to wound healing once the ulcer is fully assessed and appropriate treatment is decided. A wound is to be cleansed prior to any procedure or dressing application, for which normal saline is the best choice (never Hydrogen Peroxide). An enzymatic debrider such as Santyl is available, but should be used cautiously, especially on wounds with excess drainage, or patients with poor compliance with edema control. The cardinal rule is to keep the wound bed moist and the peri-wound dry, thus providing appropriately sufficient hydration. Alginates are used most frequently for moderate to heavy drainage.

There are also several new products available with very high absorbing capacity (Enluxtra, Drawtex, Optifoam). Collagen, foam and composite dressings are usually used for minimal to moderate drainage. When wounds are infected, dressings such as Hydrofera Blue are used, as they are able to absorb drainage, control malodor and have a broad spectrum bacteriostatic protection against MRSA and VRE. A new product used with success is Pura Ply AM matrix (collagen sheet coated with 0.1 percent PHBM).

Cellular Therapy

Another advanced therapy is through cellular therapy products (CTP), which are utilized when wounds have not healed after 30 days of regular treatment. Apligraf is the only FDA approved therapy to accelerate the healing process for non-infected venous ulcers. Apligraf is a bilayered living skin construct with a fetal foreskin keratinocyte outer layer and a second layer consisting of allogeneic fibroblasts on type 1 bovine collagen in a dermal layer of the matrix.¹

It is essential to keep in mind that any venous ulcer that does not heal within three months of onset should be sent for biopsy to rule out any malignancy. Other advanced products available originate from amniotic membranes or placenta, all loaded with multiple growth factors. Wound therapy with different types of dressings (and there are many available), should be seen as a work in progress. Patients are to be examined weekly, and adjustments to the primary dressing are made as needed.

Edema Control

Aside from treating the ulceration, edema control is a vital component of venous ulcer healing and also is known as the gold standard.¹ It will be difficult if not impossible to have a stasis ulcer healed without proper compression, and more importantly proper patient compliance with compression measures. Compression helps with reduction in distention of the superficial veins, reducing the cross-sectional area, thus improving valvular function.¹

Prior to applying compression therapy, a minimally invasive vascular test (ABI) is highly advisable. For ABI between 0.8 - 1.3, standard compression of 30-40 mmHg is recommended. In addition, light compression of 20-30mmHg is recommended for ABI of 0.5-0.8 without claudication or rest pain.^{3, 4, 5} Compression is contraindicated if ABI is <0.5 or >1.3, or with acute cellulitis, acute congestive heart failure, or acute DVT prior to administration of anticoagulation.3 Compression treatments such as single or multilayer treatments like ACE wraps (we like six-inch wraps), profore, seto wraps, Tubigrip, compression stockings, Unna boot, or modified multilayered wraps can be used.

Compression therapy includes a variety of options, such as tubular bandages, long-stretch bandages (elastic), short stretch bandages (inelastic), multilayered systems, and paste bandages. There are also support stockings and multiple Orthotic devices with Velcro (Circ-Aid, ReadyWrap).

The management of a patient with associated lymphedema requires competence and experience, especially regarding patient education, treatment, and follow up. That means constant assessment, paying attention to edema levels and the amount of drainage, and a need for multiple dressing changes. It also involves assessment of skincare, hygiene, prevention of sliding of garments or dressings, arranging for proper footwear, and avoidance of wrinkles of dressing application.10 Bony prominences should be properly padded to avoid skin maceration or damage secondary to pressure. Compression pumps for chronic associated lymphedema are valid treatments depending on the clinical signs and symptoms of venous ulceration. The key to successful compression is to start distally along the toes and continue compression more proximally to the upper calf.

Wound care centers should identify and treat venous leg ulcers in a timely fashion and, more importantly, should partner with an experienced vein center in order to refer patients for initiation of treatment of associated venous insufficiency, thereby hopefully aiding in the treatment of the venous leg ulcers.

Surgical Interventions

Last but not least are the available surgical/interventional treatment modalities for chronic ulcers, which should be done in concordance with a prestigious, experienced, and reputable vein center. Our wound care clinic is fortunate to work with an advanced vein center, which has all of treatment modalities available from minimally invasive procedures to office-based vein therapies. It is beyond the scope of this article to elucidate all of these treatment options. It is crucial for a wound care center to establish and maintain a relationship with a vein center, allowing for comprehensive, collaborative care.

Ideally, the patient will have already established care with a vein center for treatment of the underlying venous pathology as soon as the ulcer appears, before it becomes chronic. In this way, the underlying venous disease is addressed in a timely fashion to prevent chronic ulceration.

However, if the patient is seen in the wound center first, they should be referred to a vein center from there. The key point is that the earlier a patient is referred to a vein center, the better the outcome. If necessary, treatment of the venous conditions can happen concurrently with the treatment of the ulcer. You do not have to wait for the ulcer to be healed before you perform any venous procedures. The care of VLUs requires a two-pronged approach for optimal healing: treatment of the wound/peri-wound and treatment of the underlying venous pathology.^{12, 13}

In conclusion, the treatment of venous ulcers is a complex one, necessitating experience, knowledge, cooperation, and communication between several well qualified providers.

References:

1. Brem H, Kirsner RS, Falanga V. (2004). Protocol for the successful treatment of venous ulcers. Am J Surg, 188(Suppl),1-8.
2. Mourad MM, Barton SP, Marks R. (1989). Changes in endothelial cell mass, luminal volume, and capillary number in the gravitational syndrome. Br J Dermatol, 121, 447–461.
3. Bernatchez SF, Fife CE. (2017). Compression Therapy: The key to unlocking VLU healing. Today’s Wound Clinic., 11(12), 20-23
4. Harding K, Dowsett C, Fias L, et al. (2015). Simplifying venous leg ulcer management. Consensus recommendations. Wounds Int., 6(2),54.
5. Ratliff CR, Yates S, McNichol L, Gray M. (2016). Compression for primary prevention, treatment, and prevention of recurrence of venous leg ulcers: an evidence-and consensus-based algorithm for care across the continuum.
6. J Wound Ostomy Continence Nurs., 43(4), 347-64.
7. Simon DA, Dix FP, McCollum CN. (2004). Management of venous leg ulcers. BMJ., 328(7452), 1358–1362.
8. Franzeck UK, Bollinger A, Huch R, Huch A. (1984). Transcutaneous oxygen tension and capillary morphologic characteristics and density in patients with chronic venous incompetence. Circulation, 70, 806– 811.
9. Burnand KG, Whimster I, Naidoo A, Browse NL. (1982). Pericapillary fibrin in the ulcer-bearing skin of the leg: the cause of lipodermatosclerosis and venous ulceration., BMJ, 285, 1071–1072.
10. Thomas F. Donnell et all,. Management of venous ulcers: Clinical practice guideline of the Society for Vascular Surgery and the America Venous Forum.
11. Val Sulivan, PT, MS, CWS, Dot Weir, RN, CWON, CWS. (2008). Compression Therapy: Inside the Wrap. Today’s Wound Clinic, 2(1).
12. Stallard Y. (2018). When and how to perform cultures on chronic wounds? Wound Ostomy Continence Nurs.,45(2),79 – 86.
13. K.L.Todd III, MD, RPVI. (2018). Wound Clinics and Vascular Specialists Have Unique Opportunity to Improve Venous Disease. Today’s Wound Clinic,
    Relationship-Building Between the Wound Clinic and Vein Center; Q & A Session, Today’s Wound Clinic.