Preliminary Testing of New Treatment for Chronic Leg Wounds

Launched by UNIVERSITY OF PENNSYLVANIA · Jan 18, 2000

Keywords

ClinConnect Summary

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 have been disappointing. In general, therapies based on recently elucidated mechanisms of wound repair have had minimal effect on the overall number of individuals with a treated healed chronic wound. The long-term goal of this study is to evaluate a new approach for healing a chronic wound. Current methods of applying cytokines as a topical protein to treat chronic wounds result in an inadequ...

Gender

ALL

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.