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

NCT00399308 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-06-11

Study results available
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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.

Conditions

  • Leg Ulcer
  • Varicose Ulcer

Interventions

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

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00399308 on ClinicalTrials.gov