Gene Therapy to Improve Wound Healing in Patients With Diabetes

Launched by TISSUE REPAIR COMPANY · Jul 30, 2003

Keywords

ClinConnect Summary

Chronic wounds, such as diabetic ulcers, pressure ulcers, and venous stasis ulcers, cause significant morbidity in millions of patients each year in the United States. Individuals with long-standing diabetes develop both peripheral vascular disease and peripheral neuropathy. These patients may not feel pressure from shoes or objects which can damage their skin. Once a wound is formed, it may heal very slowly or not at all due to diabetic complications.

Platelet-derived growth factor-B (PDGF-B) has been approved for use in diabetic ulcers. However, delivery and maintenance of the drug at th...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Adequately controlled diabetes mellitus (type I or II) as defined by HbA1c \< 10.0%
• • Cutaneous, lower extremity, plantar medial or lateral surface ulcer between 1 and 10 cm2 post-debridement
• • Ulcer present for \> 6 weeks prior to study entry
• • Ulcer free of all necrotic and infected soft tissue
• • Affected limb transcutaneous oxygen pressure (TcpO2) \> 30 mmHg at screening or a palpable dorsal pedal or posterior tibial pulse
• • Inability to perceive 10 grams pressure using a Semmes-Weinstein 5.07 monofilament in the peri-ulcer area