Leg Ulcers Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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