Completed
Phase I Trial to Evaluate the Safety of Platelet Derived Growth Factor B (PDGF-B) and a Limb Compression Bandage in Venous Leg Ulcers
Led by University of Pennsylvania · Updated on 2013-05-13
24
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preliminary Testing of New Treatment for Chronic Leg Wounds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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