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Home > "G" Clinical Trials Conditions > Gene Therapy to Improve Wound Healing in Patients With Diabetes  Gene Therapy to Improve Wound Healing in Patients With Diabetes
Gene Therapy to Improve Wound Healing in Patients With Diabetes
For Condition: Foot wounds,Diabetes,Diabetic Foot Ulcers,Wounds and Injuries
Status: Recruiting
Sponsor(s): Selective Genetics, Inc. ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Factorial Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 21
Location and Contact Information:
Overall Study Official:
BarbaraSosnowski, Study Director, Selective Genetics, Inc.
Foot and Ankle Medical Center *Recruiting*
Phoenix, Arizona, 85015
United States
Recruiting Arthur Tallis 602-274-4100
University of California, San Diego *Recruiting*
San Diego, California, 92103
United States
Recruiting Analyn Dolopo 619-543-7341
Additional Information:
Study ID Numbers: NIAMS-093; R44 AR46154
Study Start Date: August 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065663
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1. Gene Therapy to Improve Wound Healing in Patients With Diabetes
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Gene Therapy to Improve Wound Healing in Patients With Diabetes
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