Gene Therapy to Improve Wound Healing in Patients With Diabetes

This study has been completed.
Sponsor:
Information provided by:
Tissue Repair Company
ClinicalTrials.gov Identifier:
NCT00065663
First received: July 30, 2003
Last updated: November 16, 2007
Last verified: November 2007
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Growth Factor Gene Therapy for Wound Healing

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00065663     History of Changes
Other Study ID Numbers: NIAMS-093, R44 AR46154
Study First Received: July 30, 2003
Last Updated: November 16, 2007
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

Additional relevant MeSH terms:
Diabetes Mellitus
Ulcer
Wounds and Injuries
Foot Ulcer
Diabetic Foot
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetic Neuropathies
Mitogens
Platelet-derived growth factor BB
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiogenesis Inducing Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014