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Gene Therapy to Improve Wound Healing in Patients With Diabetes

This study has been completed.

Sponsored by: Tissue Repair Company
Information provided by: Tissue Repair Company
ClinicalTrials.gov Identifier: NCT00065663
  Purpose

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.


Condition Intervention Phase
Wounds and Injuries
Diabetes
Diabetic Foot Ulcers
Foot Wounds
Genetic: GAM501
Phase I

MedlinePlus related topics:   Diabetes    Diabetic Foot    Foot Health    Injuries    Wounds   

Drug Information available for:   Becaplermin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Dose Comparison, Factorial Assignment, Safety Study
Official Title:   Growth Factor Gene Therapy for Wound Healing

Further study details as provided by Tissue Repair Company:

Estimated Enrollment:   21
Study Start Date:   August 2002
Estimated Study Completion Date:   December 2004

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065663

Locations
United States, Arizona
Foot and Ankle Medical Center    
      Phoenix, Arizona, United States, 85015
United States, California
University of California, San Diego    
      San Diego, California, United States, 92103

Sponsors and Collaborators
Tissue Repair Company

Investigators
Study Director:     Barbara Sosnowski, PhD     Tissue Repair Company    
  More Information


Tissue Repair Company Website  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   NIAMS-093, R44 AR46154
First Received:   July 30, 2003
Last Updated:   November 16, 2007
ClinicalTrials.gov Identifier:   NCT00065663
Health Authority:   United States: Food and Drug Administration

Keywords provided by Tissue Repair Company:
gene transfer  
adenovirus  
platelet-derived growth factor-B  
collagen  
diabetic ulcer  
foot
wounds
diabetic
ulcers

Study placed in the following topic categories:
Foot Ulcer
Metabolic Diseases
Diabetic Neuropathies
Skin Diseases
Adenoviridae Infections
Ulcer
Vascular Diseases
Diabetes Mellitus
Wounds and Injuries
Endocrine System Diseases
Disorders of Environmental Origin
Foot Diseases
Diabetic Angiopathies
Platelet-derived growth factor BB
Endocrinopathy
Metabolic disorder
Skin Ulcer
Glucose Metabolism Disorders
Diabetes Complications
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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