Bioengineered Skin and Wound Healing

Completed · Phase 1

Conditions studied: Leg Ulcers

In brief

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.

Key facts

Study ID

NCT00007280

Run by

Roger Williams Medical Center

People needed

50

Starts

2000-10-01

Expected to finish

2005-08-01

Last updated by the study team

2013-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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