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

June 4, 2021 updated by: Shire

An Initial Evaluation Of The Safety And Activity Of Celaderm(TM) Treatment Regimens In Healing Venous Leg Ulcers

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tamarac, Florida, United States, 33321
        • Dr. Robert Snyder
    • Illinois
      • Niles, Illinois, United States, 60714
        • National Center for Limb Preservation
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center, Division of Podiatry
    • New York
      • Bronx, New York, United States, 10461
        • Center for Curative & Palliative Wound Care, Calvary Hospital
      • Stony Brook, New York, United States, 11794
        • State University of New York Stony Brook
    • North Carolina
      • Durham, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill, Division of Vascular Surgery
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Blair Medical Associates, Inc., Station Medical Center, Associates Wound Clinic
    • Texas
      • San Antonio, Texas, United States, 78205
        • Peripheral Vascular Associates, P.A.
    • Utah
      • Saint George, Utah, United States, 84770
        • Dixie Regional Medical Center, Wound Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Multi-layer compression bandaging (Profore)
Device: Control (compression bandaging)
Multi-layer compression bandaging
Other Names:
  • Profore
Experimental: Celaderm, Bi-Weekly
Celaderm, bi-weekly applications, up to a maximum of four applications
Device: Celaderm (Frozen Cultured Epidermal Allograft)
Four biweekly applications of Celaderm plus compression therapy
Other Names:
  • Frozen Cultured Epidermal Allograft (CEA)
  • Cultured Keratinocytes
Device: Celaderm (Frozen Cultured Epidermal Allograft)
Four weekly applications of Celaderm plus compression therapy
Other Names:
  • Frozen Cultured Epidermal Allograft (CEA)
  • Cultured Keratinocytes
Experimental: Celaderm, Weekly
Celaderm, applied weekly, up to a maximum of four applications
Device: Celaderm (Frozen Cultured Epidermal Allograft)
Four biweekly applications of Celaderm plus compression therapy
Other Names:
  • Frozen Cultured Epidermal Allograft (CEA)
  • Cultured Keratinocytes
Device: Celaderm (Frozen Cultured Epidermal Allograft)
Four weekly applications of Celaderm plus compression therapy
Other Names:
  • Frozen Cultured Epidermal Allograft (CEA)
  • Cultured Keratinocytes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation.
Time Frame: 12 weeks
The primary efficacy observation was the proportion of wounds that achieved complete wound closure after 12 weeks of active treatment (i.e. of of Week 15 including screening/wash-in phase.)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.
Time Frame: 12 Weeks
Re-epithelialization was judged by the Medical Monitor based upon computerized planimetry of serial wound photographs.
12 Weeks
Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the Treatment Period.
Time Frame: Variable - minimum of 12 weeks of follow-up.
The proportion of patients who had a recurrence of the study ulcer during follow-up after achieving wound closure during the active treatment period.
Variable - minimum of 12 weeks of follow-up.
Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks).
Time Frame: 24 weeks
The proportion of patients achieving wound closure by the end of the study follow-up period, 90 days after the end of the active treatment period.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2007

Primary Completion (Actual)

April 30, 2008

Study Completion (Actual)

April 30, 2008

Study Registration Dates

First Submitted

November 10, 2006

First Submitted That Met QC Criteria

November 13, 2006

First Posted (Estimate)

November 14, 2006

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P001-001-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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