NCT00065663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2002

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

November 20, 2007

Status Verified

November 1, 2007

First QC Date

July 30, 2003

Last Update Submit

November 16, 2007

Conditions

Wounds and InjuriesDiabetesDiabetic Foot UlcersFoot Wounds

Keywords

gene transferadenovirusplatelet-derived growth factor-Bcollagendiabetic ulcerfootwoundsdiabeticulcers

Interventions

GAM501GENETIC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Foot and Ankle Medical Center

Phoenix, Arizona, 85015, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Wounds and InjuriesDiabetes MellitusDiabetic FootAdenoviridae InfectionsUlcer

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetic NeuropathiesDNA Virus InfectionsVirus DiseasesInfectionsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Barbara Sosnowski, PhD

    Tissue Repair Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 30, 2003

First Posted

July 31, 2003

Study Start

August 1, 2002

Study Completion

December 1, 2004

Last Updated

November 20, 2007

Record last verified: 2007-11

Locations

US(2)