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

NCT00399308 | Completed Phase 1 Results

• 1 other identifier: P001-001-B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

wound; leg; venous; chronic; wound healing

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy: Cumulative Proportion of Patients Completely Healed by the End of the Treatment Period, as Judged by the Investigator's Direct Observation.

  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 Outcomes (3)

• Secondary Efficacy: Proportion of Patients Achieving 90% Re-epithelialization After 12 Weeks of Active Treatment.

  12 Weeks

• Secondary Efficacy: Durability of Wound Closure Through 12 Weeks After the End of the 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).

  24 weeks

Study Arms (3)

Control

ACTIVE COMPARATOR

Multi-layer compression bandaging (Profore)

Device: Control (compression bandaging)

Celaderm, Bi-Weekly

EXPERIMENTAL

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

Device: Celaderm (Frozen Cultured Epidermal Allograft)

Celaderm, Weekly

EXPERIMENTAL

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

Device: Celaderm (Frozen Cultured Epidermal Allograft)

Interventions

Celaderm (Frozen Cultured Epidermal Allograft) DEVICE

Four biweekly applications of Celaderm plus compression therapy

Also known as: Frozen Cultured Epidermal Allograft (CEA), Cultured Keratinocytes

Celaderm, Bi-Weekly

Control (compression bandaging) DEVICE

Multi-layer compression bandaging

Also known as: Profore

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• cutaneous malignancy
• recent treatment with corticosteroids or chemotherapeutic agents
• wound exposed bone, tendon or neurovascular structure
• wound infected and requiring antibiotics

Sponsors & Collaborators

• Shire: lead

Study Sites (9)

Dr. Robert Snyder

Tamarac, Florida, 33321, United States

Location

National Center for Limb Preservation

Niles, Illinois, 60714, United States

Location

Beth Israel Deaconess Medical Center, Division of Podiatry

Boston, Massachusetts, 02215, United States

Location

State University of New York Stony Brook

Stony Brook, New York, 11794, United States

Location

Center for Curative & Palliative Wound Care, Calvary Hospital

The Bronx, New York, 10461, United States

Location

University of North Carolina at Chapel Hill, Division of Vascular Surgery

Durham, North Carolina, 27599, United States

Location

Blair Medical Associates, Inc., Station Medical Center, Associates Wound Clinic

Altoona, Pennsylvania, 16602, United States

Location

Peripheral Vascular Associates, P.A.

San Antonio, Texas, 78205, United States

Location

Dixie Regional Medical Center, Wound Care

St. George, Utah, 84770, United States

Location

MeSH Terms

Conditions

Leg Ulcer; Varicose Ulcer; Wounds and Injuries; Bronchiolitis Obliterans Syndrome

Interventions

Compression Bandages

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Limitations and Caveats

Limitations of the trial include the potential for outcome assessment bias as the study was not blinded.

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2006
• First Posted: November 14, 2006
• Study Start: January 31, 2007
• Primary Completion: April 30, 2008
• Study Completion: April 30, 2008
• Last Updated: June 11, 2021
• Results First Posted: May 16, 2013

Record last verified: 2021-06

Locations

US (9)