Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers

Shire

Status and phase: Completed; Phase 2; Phase 1

Conditions: Varicose Ulcer; Leg Ulcer

Treatments: Device: Control (compression bandaging); Device: Celaderm (Frozen Cultured Epidermal Allograft)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00399308

P001-001-B

Details and patient eligibility

About

This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.

Full description

Celaderm(TM) weekly for four weeks or biweekly for four treatments combined with Profore(R) compression vs. Profore(R) compression alone.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• venous ulcer > 1 month and < 12 months in duration; 2 to 20 sq cm in surface area; not infected
• confirmatory venous ultrasound showing prior DVT and concurrent venous reflux
• ankle-brachial index 0.80 or greater

Exclusion criteria

• cutaneous malignancy
• recent treatment with corticosteroids or chemotherapeutic agents
• wound exposed bone, tendon or neurovascular structure
• wound infected and requiring antibiotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Control

Active Comparator group

Description:

Multi-layer compression bandaging (Profore)

Treatment:

Device: Control (compression bandaging)

Celaderm, Bi-Weekly

Experimental group

Description:

Celaderm, bi-weekly applications, up to a maximum of four applications

Treatment:

Device: Celaderm (Frozen Cultured Epidermal Allograft)

Device: Celaderm (Frozen Cultured Epidermal Allograft)

Celaderm, Weekly

Experimental group

Description:

Celaderm, applied weekly, up to a maximum of four applications

Treatment:

Device: Celaderm (Frozen Cultured Epidermal Allograft)

Device: Celaderm (Frozen Cultured Epidermal Allograft)