Preliminary Testing of New Treatment for Chronic Leg Wounds

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Most chronic (long-lasting) wounds of the leg (also known as venous ulcers) fail to heal in a reasonable period of time. Although researchers have made great progress in understanding how the body repairs wounds, attempts to develop new treatments have been disappointing. In general, treatments based on recent findings about the details of wound repair have not greatly reduced the number of people who have chronic wounds. The long-term goal of this study is to evaluate a new approach for healing a chronic wound. Current methods of directly applying substances that are involved in wound healing to a chronic wound do not cause enough healing. PDGF-B (platelet-derived growth factor B), a factor associated with wound healing, might dramatically enhance healing if a genetically engineered virus is injected into the wound that causes cells in the wound to produce PDGF-B in large quantities.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: National Gene Vector Laboratory; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Platelet-derived growth factor BB

Criteria

Inclusion Criteria:

• Patient must have a venous leg ulcer.

• Patient must have failed at least 6 weeks of limb compression.

• Wound must be free of necrotic debris.

• Wound must be greater than 5 cm2 and less than 20 cm2.

• Wound must be more than 6 months old.

• Affected limb must have an ankle-brachial index (ABI) > 0.85.

• Patient must be more than 18 years old.

Exclusion Criteria:

• Any active cancer or cancer in remission for less than 10 years.

• Patients with life expectancy of less than 6 months.

• Liver function tests (Alanine Transaminase(ALT) Aspartate Amino Transfer (AST) Alkaline Phosphatase (ALK PHOS) and bilirubin) greater than 1.5x upper limit of normal for the reference lab.

• Patients with intercurrent organ damage or medical problems.

• Pregnant or lactating females.

• Any requirement for systemic corticosteroids or immunosuppressives, or history of corticosteroid or immunosuppressive use in the 4 weeks previous to study entry.

• Seropositive for hepatitis B surface antigen or hepatitis C antibody.

• Any concurrent medical illness that may be exacerbated by PDGF-B/Ad5 administration.