Gene Therapy to Improve Wound Healing in Patients With Diabetes

Completed · Phase 1

Conditions studied: Wounds and Injuries, Diabetes, Diabetic Foot Ulcers, Foot Wounds

In brief

Patients with diabetes may develop chronic wounds that respond poorly to treatment. Gene therapy with the platelet-derived growth factor-B gene has been shown to help with the healing of chronic wounds. This study will evaluate a new way to deliver the gene to the wound tissue.

Key facts

Study ID

NCT00065663

Run by

Tissue Repair Company

People needed

21

Starts

2002-08-01

Expected to finish

2004-12-01

Last updated by the study team

2007-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Foot and Ankle Medical Center — Phoenix, Arizona, United States
• University of California, San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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