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

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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00399308

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.
Study Director: David E Eisenbud, MD Shire Regenerative Medicine, Inc.
  More Information

Responsible Party: Shire Regenerative Medicine, Inc. 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

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

Additional relevant MeSH terms:
Varicose Ulcer
Leg Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Skin Diseases processed this record on May 25, 2017