Phase 2b Study of GAM501 in the Treatment of Diabetic Ulcers of the Lower Extremities
Public ClinicalTrials.gov record NCT00493051. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00493051
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 124 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2007 (Type not available)
- Primary completion
- Dec 2009 (Actual)
- Completion
- Dec 2009 (Actual)
- Last update posted
- Feb 10, 2010
2007 – 2009
United States locations
- U.S. sites
- 29
- U.S. states
- 13
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Baptist Medical Center South | Montgomery | Alabama | 36111 | — |
| Banner Baywood Medical Center | Mesa | Arizona | 85206 | — |
| Associated Foot & Ankle Specialists | Phoenix | Arizona | 85015 | — |
| Aung Foothealth Clinics | Tuscon | Arizona | 85710 | — |
| Absolute Foot Care | Chula Vista | California | 91910 | — |
| Dr. Roy Kroeker DPM | Fresno | California | 93710 | — |
| Dr. Jagpreet Mukker | Fresno | California | 93726 | — |
| Long Beach VA Health Care System | Long Beach | California | 90822 | — |
| LAC-USC Medical Center | Los Angeles | California | 90033 | — |
| Innovative Medical Technologies | Los Angeles | California | 90063 | — |
| UCLA Medical Center Olive View | Sylmar | California | 91342 | — |
| Foot Doctors of Watsonville | Watsonville | California | 95076 | — |
| North American Center for Limb Preservation | New Haven | Connecticut | 06515 | — |
| Providence Hospital Clinical Research Center | Washington D.C. | District of Columbia | 20017 | — |
| Bay Pines VAHCS | Bay Pines | Florida | 33744 | — |
| Karr Foot Kare | Lakeland | Florida | 33813 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Advanced Foot & Ankle Center | Las Vegas | Nevada | 89119 | — |
| Division of Wound Healing & Regenerative Medicine NYU School of Medicine | New York | New York | 10016 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Leigh Valley Hospital | Allentown | Pennsylvania | 18105 | — |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | — |
| Warren General Hospital | Warren | Pennsylvania | 16365 | — |
| Presbyterian Hospital of Dallas | Dallas | Texas | 75231 | — |
| University of Texas Medical Branch | Galveston | Texas | 77555 | — |
| St. Joseph Medical Center | Houston | Texas | 77002 | — |
| South Texas Foot Institute | San Antonio | Texas | 78224 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00493051, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 10, 2010 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00493051 live on ClinicalTrials.gov.