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Phase 2b Study of GAM501 in the Treatment of Diabetic Ulcers of the Lower Extremities

NCT00493051 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2010-02-10

No results posted yet for this study

Summary

This is a Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of one or two applications of topically applied GAM501 (Ad5PDGF-B/Bovine Type I Collagen Gel) in subjects ≥ 18 years old with non-healing diabetic foot ulcers. Approximately 210 adult subjects with Type I or Type II diabetes mellitus will be enrolled at approximately 30 investigational sites in the United States.

Conditions

  • Diabetic Foot

Interventions

BIOLOGICAL

GAM501

Ad5PDGF-B formulated in a collagen gel

BIOLOGICAL

Placebo

Collagen gel

OTHER

Standard of care

moist dressing changes daily

Sponsors & Collaborators

  • Cardium Therapeutics

    collaborator INDUSTRY

  • Tissue Repair Company

    lead INDUSTRY

Principal Investigators

  • Jeff Kittrelle, MD · Tissue Repair Company, 6740 Top Gun St, San Diego, CA 92121 USA, 858-259-4511

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00493051 on ClinicalTrials.gov