Bioengineered Skin and Wound Healing

August 1, 2013 updated by: Roger Williams Medical Center

Mechanisms of Bioengineered Skin in Human Wounds

This study will look at whether a graft of bioengineered skin (BSC), known commercially as Apligraf, stimulates the healing process in a person's own skin at the edge of a wound (known as the edge effect). The information from this study will provide a better understanding of the ways that grafts of bioengineered skin help the healing of chronic wounds.

We will assign study participants to either the bioengineered skin group or the control group. People in the control group will receive compression therapy with a multilayered compression bandage. We will examine each participant before starting treatment and then once a week for 24 weeks or until the wound heals. On the first day of treatment (day 0) and at week 3, week 6, and week 24 (end of treatment) we will take a small tissue sample from the wound for a biopsy. After the wound is completely healed, we will ask the patient to return once a month for 6 months to make sure the wound stays healed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BSC is a two-layered sheet made from purified beef tendon collagen, living human cells, and a substance that maintains the cells until they are grafted (removed). We will obtain human cells from donors unrelated to the patient. The human cells have been tested for the presence of infectious agents and found to be free of disease-causing organisms such as hepatitis virus, the AIDS virus, bacteria, and fungi.

We will randomly assign (randomize) study participants to either the bioengineered skin group or control group (compression therapy with a multilayered compression bandage). Regardless of the group to which a patient is assigned, we expect participation in this study for 12 months following the start of study treatment. We will examine each patient at the screening visit (2 weeks before randomization) and then again 3-4 days before the start of treatment to make sure the wound is free of any signs of infection. After the initial randomization visit we will examine the wound once a week for 24 weeks or until the wound heals, whichever is earlier. As soon as we have determined that the wound is completely healed, we will ask the patient to return once a month for 6 months to make sure it remains healed.

Bioengineered skin group: We will apply BSC to the wound and cover it with xeroform dressing, foam bolster, gauze dressing, and compression bandage. If we do not note any improvement at the week 6 visit, we will apply BSC on the wound a second time.

Control group: We will place a multilayered compression bandage on the wound of participants assigned to this group.

Biopsies (small piece of skin tissue): At day 0 a biopsy will be taken from the thigh and leg ulcer. The biopsy from the thigh will require sutures and will be removed in ten days. Sometime between weeks 1 and 3, week 6, week 24 and week 48 (6 month follow-up) visits a biopsy will be taken from the ulcer (wound) if the ulcer has not healed. If the ulcer is healed at the week 48 visit, a light scraping of the healed wound will be performed.

Study examinations: All study examinations will include observation, measurement, and photography.

We can only admit women of childbearing age to the study if they are not breast feeding, not pregnant, or have been surgically sterilized or are using effective birth control. Because the effects of the proposed treatments on a fetus are unknown, we will remove from the study any woman who becomes pregnant while receiving BSC applications (day 0-week 3) and suggest another method of treatment.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • 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
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
        • Roger Williams Medical Center Dept. of Dermatology & Skin Surgery

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women at least 18 years old
  • At least one ulcer (wound) greater than or equal to 2 centimeters
  • Ulcer (wound) present for at least 3 months or greater
  • Ankle/brachial index > 0.7
  • Patient must be ambulatory
  • Patient must read, understand and sign informed consent

Exclusion Criteria:

  • Medical conditions limiting participation
  • History of poor compliance, unreliability
  • History of allergy to bovine collagen
  • Gangrene, vasculitis, collagen vascular disease osteomyelitis or exposed tendons
  • Use of systemic steroids/immunosuppressives
  • History of diabetes mellitus

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: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement and characterization of stimulation of the wound's edges treated with the bioengineered skin construct (BSC)
Time Frame: Measured throughout the study till Week 48
Measured throughout the study till Week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Response of BSC to injury, including meshed (wounded) and unmeshed BSC
Time Frame: Measured throughout the study till Week 48
Measured throughout the study till Week 48
Activation of certain critical cytokines, including IL-1 alpha, IL-6, and TGF-beta
Time Frame: Measured throughout the study till Week 48
Measured throughout the study till Week 48

Collaborators and Investigators

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

Sponsor

Roger Williams Medical Center

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Vincent Falanga, MD, Roger Williams Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2000

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

December 16, 2000

First Submitted That Met QC Criteria

December 16, 2000

First Posted (Estimate)

December 18, 2000

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AR046557 (U.S. NIH Grant/Contract)
  • NIAMS-060

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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