Trials / Completed
CompletedNCT00399308
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Celaderm(TM) weekly for four weeks or biweekly for four treatments combined with Profore(R) compression vs. Profore(R) compression alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Celaderm (Frozen Cultured Epidermal Allograft) | Four biweekly applications of Celaderm plus compression therapy |
| DEVICE | Celaderm (Frozen Cultured Epidermal Allograft) | Four weekly applications of Celaderm plus compression therapy |
| DEVICE | Control (compression bandaging) | Multi-layer compression bandaging |
Timeline
- Start date
- 2007-01-31
- Primary completion
- 2008-04-30
- Completion
- 2008-04-30
- First posted
- 2006-11-14
- Last updated
- 2021-06-11
- Results posted
- 2013-05-16
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00399308. Inclusion in this directory is not an endorsement.