Phase 2
Completed N=40
Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
Leg Ulcer · Varicose Ulcer
Source: ClinicalTrials.gov NCT00399308 ↗
Enrolled (actual)
40
Serious AEs
20.0%
Results posted
May 2013
Primary outcomePrimary: Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation. — 1; 4; 3 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation. |
1; 4; 3 | — |
| SECONDARY Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment. |
1; 5; 3 | — |
| SECONDARY Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period. |
0; 1; 0 | — |
| SECONDARY Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks). |
3; 7; 5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00399308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.