Protocol for the Management of Venous Leg Ulcers in the Western Cape

Introduction
At which level should patients be treated?
Admission to hospital
Referral to surgery
Compression therapy
Local ulcer care
Drug therapy
Surgery
Implementation strategy for Venous Ulcer protocol
Management/treatment

Introduction

Chronic venous ulcers affects 0.5% - 2% of the population but may affect as many as 4% of patients over the age of 60.  Leg ulcers usually have a protracted course of variable healing rates and outcomes.  Leg ulcers can recur; -25% of patients with leg ulcers may have up to 6 leg ulcer recurrences in their lifetime. Delayed healing and frequent recurrence results in pain, disability, decreased quality of life, social stigmatisation and loss of working days.

The goal of this protocol is not to provide an exhaustive medical review on the topic, but to agree to some minimum standards which are currently not adhered to in the Western Cape. 

At which level should patients be treated?

Specialist leg ulcer clinics are recommended as the optimal service for community treatment of venous leg ulcers. In the ESCHAR study patients were initially evaluated by the vascular service and there-after compression therapy was done by trained staff on a shared-care basis between specialist-nurse led leg ulcer clinics and the community or district nurses, with close liaison between the two.

The above scenario reflects an ideal situation.  In the Western Cape a realistic approach would be for every patient with a leg ulcer to be evaluated, initially by a medical doctor at the community health centre or district hospital (Level 1).  Patients should be assessed for peripheral arterial disease, rheumatoid arthritis, and diabetes mellitus.  Ideally an ankle-brachial index (ABI) should be measured by hand held Doppler which should be available at district hospitals (Level 1).  Compression therapy should also occur at district level and this is the mainstay of treatment.  The importance of specialist wound care nurses cannot be overemphasised as well as correct training of nursing staff applying compression bandages.

Admission to hospital

infected, painful or heavily exudating leg ulcers must be admitted. 

Leg elevation, regular dressings, antibiotics and the need for anticoagulation is facilitated in hospital.

Surgery Evaluation (at level 2 / 3 service)

This evaluation must incorporate a mandatory duplex ultrasound of the venous system.  The duplex study should evaluate both the superficial and deep systems in both lower limbs for both occlusive and refluxing venous disease.  Further studies such as CT venography, venography and intravascular ultrasound (IVUS) may be indicated with a view to superficial vein ablative therapies or deep venous reconstructive procedures.

Referral to surgery

General or vascular surgeon at an early stage of management:

• Suspicion of malignancy (biopsy for atypical or non-healing ulcers)
• Peripheral arterial disease (ABI <0.9)
• Diabetes mellitus/ Peripheral neuropathy
• Rheumatoid arthritis/Vasculitis
• Atypical distribution of ulcers
• Suspected contact dermatitis or dermatitis resistant to topical steroids
• Ulcers not healing predictably within 12 weeks in other words slow or non-healing ulcers      
• Recurrent leg ulcers
• Large ulcers (>10 cm)
• Deep ulcers
• All HIV positive patients with leg ulcers
• Circumferential leg ulcers

The establishment of or retainment of multi-disciplinary specialist leg ulcer clinics with co-operation between all levels should still remain the ultimate goal. The establishment of a leg ulcer network has provided enormous benefits in terms of leg ulcer management, reducing the prevalence of leg ulcers and health care cost saving.

Compression therapy

There is a level 1A evidence that graduated compression bandaging promotes the healing of venous ulcers and level 1B evidence for strong compression hosiery (30-40 mmHg).  There is also level 1A evidence that compression hosiery (30-40 mmHg) prevents recurrence of ulceration after healing.  

Patient compliance remains a problem with compression hosiery.  In the ESCHAR study class 2 community grade elastic stockings (20-30 mmHg) was used.

The use of TED (thrombo-embolic deterrent) stockings (12-18 mmHg) does not provide adequate compression for the treatment of venous ulcers and should not be used for this indication.

For patients with clean, granulating, non-infected leg ulcers high compression multi-component or multi-layered bandaging should be routinely used.  The application of single layer bandages is not acceptable and does not result in ulcer healing.  The use of multi-layered compression bandaging has been found to be consistently superior to single layer dressings in Chochrane reviews.  The use of tubi-grip offers very little compression and is only mentioned to be condemned.  Small open ulcers with low exudates can be treated with simple dressings and knee-length compression stocking in patients who are not obese. 

Once ulcers are healed, at least a class 2 graduated compression stocking (20-30 mmHg) should be applied although evidence suggests that stronger compression hosiery (30-40 mmHg) may be more effective (although compliance may be less).  Knee length stockings result in better patient compliance (although this is less effective than full length stockings).  This should be continued lifelong.  Patients should have repeat sizing and new graduated compression stocking issued every 6 months.

Compression therapy should be combined with leg exercise and periods of leg elevation when recumbent, and with the leg resting on a chair or foot-rest when seated.

The following guidelines from the American Venous Forum summarise the above:

1. Compression therapy is the primary treatment of venous leg ulceration
2. No one form of compression therapy (compression bandaging vs. graduated compression stocking) is clearly superior to the other in the initial management of leg ulcers.  Compression methods should be individualised to every patient.
3. Compliance is integral to initial success with compression therapy and we recommend long term compression to reduce recurrence of leg ulceration. 

Definitions:     Conventional venous leg ulcer healing: heals within 12 weeks

Slow healing leg ulcer: heals within 12 weeks – 1 year

Non-healing leg ulcer: not healing > 1 year

There should be a low threshold for referring poorly healing or non-healing leg ulcers for evaluation

Local ulcer care

A systematic review of 20 RCT by O’Donnell and Lau found that certain wound dressings improves the proportion and time to ulcer healing over simple dressings.  A recent Cochrane review of 42 RCT concluded that the type of dressing applied beneath the compression does not affect ulcer healing.

The Scottish intercollegiate guidelines network (SIGN) recommends the following:  Sharp debridement, when indicated, should only be done by trained practitioners.  Simple non-adherent dressings are recommended as a first line for clean, non-infected leg ulcers.  For highly exudating, infected wounds initial dressings with dry gauze with frequency change informed by the degree of soiling should be adequate as initial therapy for most patients that are admitted.  Honey and silver dressings are not routinely recommended.  Acetic acid or Betadine dressings may be used in the acute phase of wound management but long-term use is not recommended.  The surface area of the ulcer should be measured serially over time.  Patients with non-healing or atypical ulcer should be referred for evaluation.  Bacterial swabs must be taken if there is clinical evidence of infection.  Leg ulcers with eczema/dermatitis should be considered for patch testing by a dermatologist.  It is also recommended to avoid products known to cause skin sensitivity.  There is no evidence for expensive “designer” wound dressings.

Drug therapy

Both pentoxyfylline and micronised purified flavonoid fraction were shown to promote ulcer healing when combined with compression therapy.  Pentoxyfilline 400mg three times daily for up to 6 months should be considered in patients with venous leg ulcers.  Although there is scientific evidence for the above drug therapy the surgical Provincial Coordinating Committee has agreed to rather focus on correct compression therapy than costly drugs (which are currently not on code in the province) and these drugs will therefore not be prescribed routinely.  Wound infection is managed with cleaning and debridement.  Systemic antibiotics are reserved for signs of cellulitis or systemic infection.

Surgery

Evidence from prospective randomised trials confirms that patients with isolated superficial venous reflux or mixed superficial and deep reflux, ulcer recurrence is decreased with superficial vein surgery (high ligation, division and stripping of the saphenous vein) although this does not speed up ulcer healing.  Where possible, or indicated, minimally invasive endovenous vein ablative techniques (laser, radio frequency, foam) should be used.  Most patients with venous ulceration will benefit from the addition of simple venous surgery to compression therapy if deep vein obstruction was excluded by duplex Doppler.  This should be performed at level 2 or level 3 facilities only.

Evidence is increasing about the superiority of endovenous interventions (laser, radio frequency ablation) above classical surgical intervention.  Performing these procedures will depend on local interest, capital resources and available theatre time and should only be done at level 3 centres.

Treatment of iliac vein obstruction is important and venous stents have been effective and durable.  Open surgery is only considered for iliac or ileocaval venous obstruction if endovascular treatment is not possible or has already failed.   These procedures should be performed at level 3 centres only.

Implementation strategy for Venous Ulcer Protocol

There are many layers in the protocol

1. The mainstay is correct high pressure multi-layer compression bandages for active ulcers at district level with class 2 or 3 compression stockings to prevent recurrences of healed ulcers.  
2. The protocol also aims for correct management at secondary and tertiary level which mandates duplex Doppler and further investigation and treatment (stenting or surgery) as required.

As a first step correct management at district level is required

1. Correct bandages and stockings have to be available at clinics and district hospitals.
2. The tender process for the above has recently closed, but in awarding the tender it is important that a company is chosen that provides support in correct application of bandages.
3. For each GSA a contact manager needs to be named that the level 2 head of the GSA (or the relevant vascular surgeon) can contact if correct therapy is not available at a clinic or district hospital.

A second step would be correct evaluation and treatment at secondary or tertiary level.  Although duplex is widely used to diagnose Deep Venous Thrombosis, correct evaluation of the venous system for incompetence is not widely practised.  This process will have to be driven by the vascular surgery services/general surgery services in their respective hospitals.

Varicose veins: Patients with symptomatic visible varicose veins and no history of previous DVT can be seen at surgical  clinic.

Patients with history of DVT or Venous Ulcers (active or healed) should be seen at GSH varicose vein clinic. Ask for copy of duplex Doppler report in referral letter. After seen at GSH these patients can be followed up in surgical outreach clinic.

Venous stasis ulcers: these are common debilitating problems. Typically they present with long standing, recurrent ulceration at or above the medial malleolus.

Assessment

• Assessment of the patient for peripheral arterial disease, rheumatoid arthritis and systemic vasculitis, and diabetes mellitus
• Measurement of ankle brachial pressure ratio index (ABPI) by Doppler
• Measurement of ulcer surface area over time + monitor at dressing change
• Ulcer biopsy if unusual or non healing
• Bacteriological swabs if evidence of infection
• Dermatitis/eczema patch testing
• Specialist referral to Vascular OPD if non healing/ associated with major superficial varicose veins or unusual concerns

Management/Treatment

• Sharp debridement may be necessary(with local anaesthetic cream to reduce pain)
• Simple non-adherent dressings, e.g. Jelonet
• High compression multi-component bandaging X 6 weeks
• Antibiotics if evidence of clinical infection, (oral Cloxacillin or Co-amoxyclav)
• Pentoxifylline
• Recurrence prevention
  • Below knee graduated compression hosiery
  • Superficial venous surgery
• Ideal follow up is for day hospital or community clinic to run wound care/ leg ulcer clinic services