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NCT Number: NCT00399308

Evaluation of Safety and Activity of Celaderm 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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dr. Robert Snyder, Tamarac, Florida, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celaderm (Frozen Cultured Epidermal Allograft)

Device

Four biweekly applications of Celaderm plus compression therapy

Other names: Frozen Cultured Epidermal Allograft (CEA), Cultured Keratinocytes

Control (compression bandaging)

Device

Multi-layer compression bandaging

Other names: Profore

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.

    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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 14, 2006
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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