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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Celaderm(TM) weekly for four weeks or biweekly for four treatments combined with Profore(R) compression vs. Profore(R) compression alone.

Conditions

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Leg Ulcer Varicose Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Multi-layer compression bandaging (Profore)

Group Type ACTIVE_COMPARATOR

Control (compression bandaging)

Intervention Type DEVICE

Multi-layer compression bandaging

Celaderm, Bi-Weekly

Celaderm, bi-weekly applications, up to a maximum of four applications

Group Type EXPERIMENTAL

Celaderm (Frozen Cultured Epidermal Allograft)

Intervention Type DEVICE

Four biweekly applications of Celaderm plus compression therapy

Celaderm, Weekly

Celaderm, applied weekly, up to a maximum of four applications

Group Type EXPERIMENTAL

Celaderm (Frozen Cultured Epidermal Allograft)

Intervention Type DEVICE

Four weekly applications of Celaderm plus compression therapy

Interventions

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Celaderm (Frozen Cultured Epidermal Allograft)

Four biweekly applications of Celaderm plus compression therapy

Intervention Type DEVICE

Celaderm (Frozen Cultured Epidermal Allograft)

Four weekly applications of Celaderm plus compression therapy

Intervention Type DEVICE

Control (compression bandaging)

Multi-layer compression bandaging

Intervention Type DEVICE

Other Intervention Names

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Frozen Cultured Epidermal Allograft (CEA) Cultured Keratinocytes Frozen Cultured Epidermal Allograft (CEA) Cultured Keratinocytes Profore

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No