Status:
COMPLETED
Preliminary Testing of New Treatment for Chronic Leg Wounds
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Gene Vector Laboratory
Conditions:
Varicose Ulcer
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief 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 rep...
Detailed Description
Most chronic wounds of the leg fail to heal in a reasonable period of time. In fact, despite considerable advances in elucidating the molecular basis of wound repair, attempts to develop new therapies...
Eligibility 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00000431
Start Date
January 1 2005
End Date
March 1 2011
Last Update
May 13 2013
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104