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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire Regenerative Medicine, Inc.
ClinicalTrials.gov Identifier:
NCT00399308
First received: November 10, 2006
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Leg Ulcer
Varicose Ulcer
Device: Celaderm (Frozen Cultured Epidermal Allograft)
Device: Control (compression bandaging)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Initial Evaluation Of The Safety And Activity Of Celaderm(TM) Treatment Regimens In Healing Venous Leg Ulcers

Resource links provided by NLM:


Further study details as provided by Shire Regenerative Medicine, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.)


Secondary Outcome Measures:
  • Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Re-epithelialization was judged by the Medical Monitor based upon computerized planimetry of serial wound photographs.

  • 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. ] [ Designated as safety issue: Yes ]
    The proportion of patients who had a recurrence of the study ulcer during follow-up after achieving wound closure during the active treatment period.

  • Secondary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Follow-up Period (24 Weeks). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: January 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Multi-layer compression bandaging (Profore)
Device: Control (compression bandaging)
Multi-layer compression bandaging
Other Name: 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
Experimental: Celaderm, Weekly
Celaderm, applied weekly, up to a maximum of four applications
Device: Celaderm (Frozen Cultured Epidermal Allograft)
Four weekly applications of Celaderm plus compression therapy
Other Names:
  • Frozen Cultured Epidermal Allograft (CEA)
  • Cultured Keratinocytes

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399308

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

No publications provided

Responsible Party: Shire Regenerative Medicine, Inc.
ClinicalTrials.gov Identifier: NCT00399308     History of Changes
Other Study ID Numbers: P001-001-B
Study First Received: November 10, 2006
Results First Received: March 18, 2013
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire Regenerative Medicine, Inc.:
wound
leg
venous
chronic
wound healing

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014