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

An Initial Evaluation Of The Safety And Activity Of Celaderm(TM) Treatment Regimens In Healing Venous Leg Ulcers

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.

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

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