Becaplermin Gel for MARTORELL's Hypertensive Leg Ulcers

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Background: No medical treatment has proved its efficacy for the treatment of hypertensive leg ulcers in a well designed trial.

Primary aim of the study: to compare the rate of healing in hypertensive leg ulcers treated with becaplermin gel (Regranex Gel®) daily application versus the application of the same quantity of an hydrogel (Duoderm Hydrogel™), corresponding to the excipient of becaplermin gel.

Method: Ambulatory or hospitalized patients presenting with an hypertensive leg ulcer, were randomized to receive either a daily application of becaplermin gel or hydrogel during 8 weeks. At week 8, a pinch graft was proposed to patients whom the ulcer has not healed.

Primary aim of the study: Complete closure at week 8

Secondary aims: percentage of wound area reduction at week 8, complete closure at week 12, pain and quality of life during treatment

Study hypothesis: becaplermin gel may promote the healing of hypertensive leg ulcers and be an alternative medical treatment to the skin graft usually proposed

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Becaplermin; Platelet-derived growth factor BB

Criteria

Inclusion Criteria:

• patients 18 years of age or older, able to give informed consent and to follow the treatment procedure

• target ulcer area between 1 and 30 cm2

• consecutive patients presenting with one or more leg ulcers diagnosed as hypertensive MARTORELL's ulcers

• presence of an arterial hypertension, according to the WHO criteria, treated or not; and/or presence of a diabetes treated by oral agent, insulin or diet

• absence of clinical signs of chronic venous insufficiency: skin hyperpigmentation, lipodermatosclerosis

• absence of significant peripheral arterial occlusive disease: presence of peripheral pulses or ankle brachial index ≥0.8

• absence of clinical sign of arterial insufficiency: intermittent claudication, resting pain

• superficial spreading necrotic ulcer

• presence of spontaneous pain

• presence of a red purpuric margin

Exclusion Criteria:

• pregnancy

• allergy to hydrogel or to becaplermin gel

• uncontrolled or evolving systemic disease: cardiac or renal failure, hepatic insufficiency, malignant disease, thrombotic disease, vasculitis or other connective tissue disorder

• presence of a cryoglobulinemia

• serum creatinine concentration greater than 200µmol/L or uncontrolled diabetes (fasting blood glucose > 2,5 g/L under treatment)

• concomitant treatment by ILOMEDINE

• bone, joint or tendon (except for achilles tendon) exposition in the wound

• systemic treatment with corticosteroid agents or cytotoxic drugs in the past 3 months before inclusion