A Randomized, Double-Blind, Placebo-Controlled, Single- and Double-Dose, Comparator Arm (Standard of Care), Multicenter Phase 2b Study of Topical GAM501 (Ad5PDGF-B/Bovine Type I Collagen Gel) in the Treatment of Non-Healing Diabetic Ulcers of the Lower Extremities

Tissue Repair Company29 sites in 1 country124 target enrollmentNovember 2007

ConditionsDiabetic Foot

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Diabetic Foot
Sponsor: Tissue Repair Company
Enrollment: 124
Locations: 29
Primary Endpoint: Effect of GAM501 on the incidence of complete ulcer closure
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

December 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tissue Repair Company

Eligibility Criteria

Inclusion Criteria

•Age 18 years or older
•Diagnosis of diabetes mellitus (Type I or II) requiring insulin or hypoglycemic agents to control blood sugars.
•Cutaneous, lower extremity ulcer of the foot that is ≥1.5 and ≤10.0 cm² in size and Wagner Classification Grade 1 in appearance. Note - Ulcer area must be calculated at Screening Visit and on the Treatment Day (Day 1) using measurements obtained by tracing the ulcer perimeter after debridement to confirm patient eligibility prior to randomization.
•Documented ulcer presence for ≥6 weeks prior to signing the informed consent form
•Recently debrided ulcer (within 2 weeks from screening visit)
•Ulcer free of all necrotic soft tissue
•Affected limb transcutaneous partial pressure oxygen (TcpO2) \>40mmHg; or a toe pressure ≥40mmHg; or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at screening
•Inability to perceive 10 grams pressure using a Semmes-Weinstein 5.07 monofilament in the peri-ulcer area
•Willing to adhere to wearing off-loading orthopedic shoe for up to 16 weeks (i.e., through 2 weeks after ulcer closure) starting on Day -14 (the first day of the screening run-in period)
•Willing to adhere to wearing customized shoes during the durability phase of the study

Exclusion Criteria

•Any unstable medical condition judged by the Investigator or Medical Monitor that would cause the study to be detrimental to the patient
•Hemoglobin Alc (HbA1c) test result of \>12% documented at the Screening Visit
•Ulcers caused primarily by untreated vascular insufficiency; or ulcers with an etiology not related to diabetes
•Ulcers on the heel
•More than three ulcers on the target lower extremity
•The ulcer to be studied is not anatomically distinct from another ulcer(s) (i.e., separated by \<1 cm from another ulcer or would interfere with standard of care treatment of another ulcer). Only a single ulcer can be treated in this study.
•Ulcers which decrease in area by \>30% during the screening 2-week run-in period
•Ulcers with underlying osteomyelitis
•Patients presenting with the clinical characteristics of cellulitis at the ulcer site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever)
•If either beta hemolytic streptococci (in any amount) or total bacterial load of \>1e6 CFU/gram of tissue is present in the screening biopsy sample at the ulcer site, the patient should be given a single 7-day course of topical antibiotics and then redebrided and biopsied for quantitative culture. A second biopsy exceeding the limits above will result in exclusion from the study due to the high risk of local infection than may adversely affect ulcer closure.

Outcomes

Primary Outcomes

Effect of GAM501 on the incidence of complete ulcer closure

Time Frame: Week 12 or earlier

Secondary Outcomes

The absolute change and percent change in ulcer area(From baseline ulcer area and measured at weekly intervals through week 12)
The durability of ulcer closure(Measured at 4 week intervals for 12 weeks from date of ulcer closure)
Time to complete ulcer closure(The time from treatment start to first visit when ulcer closure is documented)
Safety and tolerance(Week 12 or earlier)
Ulcer healing trajectories will be assessed by plots of percentage of ulcer closure versus time(Week 12 or earlier)