Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Cardiology, Gastrointestinal |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 6/27/2018 |
| Start Date: | January 2007 |
| End Date: | April 2008 |
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.
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.
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
We found this trial at
9
sites
Altoona, Pennsylvania 16602
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Durham, North Carolina 27599
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