At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
Celaderm (Frozen Cultured Epidermal Allograft) +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Initial Evaluation Of The Safety And Activity Of Celaderm(TM) Treatment Regimens In Healing Venous Leg Ulcers
In Brief
A Phase 2 clinical trial evaluating Celaderm (Frozen Cultured Epidermal Allograft) and Control (compression bandaging) for Leg Ulcer and Varicose Ulcer. Completed, enrolled 40 participants across 9 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeg Ulcer, Varicose Ulcer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2006
Enrollment StartJan 2007
Primary CompletionApr 2008
TodayJul 2026
First PostedNov 14, 2006
Enrollment StartJan 31, 2007
Primary CompletionApr 30, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.6 years ago
Interventions
Celaderm (Frozen Cultured Epidermal Allograft)device
Four biweekly applications of Celaderm plus compression therapy
Celaderm (Frozen Cultured Epidermal Allograft)device
Four weekly applications of Celaderm plus compression therapy
Control (compression bandaging)device
Multi-layer compression bandaging