Becaplermin Gel for MARTORELL's Hypertensive Leg Ulcers

NCT00970697 | Completed Phase 3

• 1 other identifier: P020706
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

MARTORELL'S ULCER; Hypertensive Leg Ulcer; Necrotic Angiodermatitis

Keywords

MARTORELL'S ULCER; hydrogel; Hypertensive leg ulcer

Outcome Measures

Primary Outcomes (1)

• Complete wound closure rate at week 8 of treatment

  week 9

Secondary Outcomes (4)

• Complete wound closure rate at week 12 of treatment

  week 13

• pain and quality of life evolution during the treatment( W4,8,10,12),

  week 9

• % of wound area reduction at week 8 and 12

  weeks 9 and 13

• safety of the treatment at week 4, 8 and 12

  week 13

Study Arms (2)

becaplermin gel

EXPERIMENTAL

application of a continuous thin layer of becaplermin gel (Regranex Gel®) during 8 weeks. The amount of the gel to be applied was determined based on ulcer area at inclusion, and remains identical during all the treatment.

Drug: becaplermin gel

Duoderm Hydrogel™

ACTIVE COMPARATOR

application of a continuous thin layer of hydrogel dressing (Duoderm Hydrogel®), during 8 weeks. Duoderm Hydrogel™ is a sodium carboxymethylcellulose aqueous-based gel, similar in composition to becaplermin excipient.

Drug: Duoderm Hydrogel™

Interventions

becaplermin gel DRUG

the amount of the gel to be applied was determined based on ulcer area at inclusion and remains identical during all the treatment The posology was identical to what is recommended for Regranex gel®: a single 15g-tube is enough to treat a 5 cm2-wound during 6 weeks (1 cm of gel is applied daily for 5 cm2) Wound was then recovered by a moist saline gauze and a bandage. Becaplermin gel is packaged into masked 15g-tubes.

becaplermin gel

Duoderm Hydrogel™ DRUG

The amount of the gel to be applied was determined based on ulcer area at inclusion, and remains identical during all the treatment. The posology was identical to what is recommended for Regranex gel®: a single 15g-tube is enough to treat a 5 cm2-wound during 6 weeks (1 cm of gel is applied daily for 5 cm2) Wound was then recovered by a moist saline gauze and a bandage. Hydrogel dressing is identical in appearance, color, consistency, and odor than becaplermin gel, and packaged in similar masked15g-tubes.

Duoderm Hydrogel™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Charles Foix

Ivry-sur-Seine, Île-de-France Region, France

Location

Related Publications (1)

• Senet P, Vicaut E, Beneton N, Debure C, Lok C, Chosidow O. Topical treatment of hypertensive leg ulcers with platelet-derived growth factor-BB: a randomized controlled trial. Arch Dermatol. 2011 Aug;147(8):926-30. doi: 10.1001/archdermatol.2011.84. Epub 2011 Apr 11.

  PMID: 21482863 DERIVED

MeSH Terms

Interventions

Bandages, Hydrocolloid

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Officials

• Patricia SENET

  Dermatology, Charles Foix

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: January 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 4, 2011

Record last verified: 2011-09

Locations

FR (1)