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.

Condition	Treatment or Intervention	Phase
Leg Ulcers	Device: Bioengineered skin	Phase I

Further Study Details: 

Expected Total Enrollment:  50

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Polly Carson      401-456-2062    pcarson@rwmc.org

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

Study chairs or principal investigators

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

Study ID Numbers:  NIAMS-060; R01 AR46557
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  December 16, 2000
ClinicalTrials.gov Identifier:  NCT00007280
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08