Gene Therapy to Improve Wound Healing in Patients With Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Wounds and Injuries Diabetes Diabetic Foot Ulcers Foot Wounds

Keywords

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gene transfer adenovirus platelet-derived growth factor-B collagen diabetic ulcer foot wounds diabetic ulcers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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GAM501

Intervention Type GENETIC

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Barbara Sosnowski, PhD

Role: STUDY_DIRECTOR

Tissue Repair Company

Locations

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Foot and Ankle Medical Center

Phoenix, Arizona, United States

Site Status

University of California, San Diego

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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R44AR046154

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAMS-093

Identifier Type: -

Identifier Source: org_study_id