Gene Therapy to Improve Wound Healing in Patients With Diabetes

Phase 1

Completed

• Conditions: Wounds and Injuries; Diabetes; Diabetic Foot Ulcers; Foot Wounds

• Registration Number: NCT00065663
• Lead Sponsor: Tissue Repair Company

Brief Summary

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.

Detailed Description

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 the wound site in sufficient quantities for a sufficient period of time is a major hurdle to widespread use.

Gene activated matrix (GAM) technology offers the opportunity to place a therapeutic gene contained within a structural matrix into a wound site. This study will evaluate the safety and potential clinical utility of topical applications of GAM501, a gene for PDGF-B contained within an E1-deleted adenoviral vector and formulated in a bovine type I collagen gel. This formulation allows for the migration of wound repair cells into the structural matrix, where they encounter the viral vector and subsequently produce the therapeutic protein within the local wound environment.

Participants in this study will receive up to four treatments with GAM501. Participants will be followed by multiple observations over a 6 to 7 month period.

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2003-07-30
• Study First Submitted QC: 2003-07-30
• Study First Posted: 2003-07-31
• Study Completion: 2004-12
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-16
• Last Update Posted: 2007-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Trial Locations

Locations (2)

Foot and Ankle Medical Center; 🇺🇸 Phoenix, Arizona, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States