Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Tissue Repair Company Cardium Therapeutics |
---|---|
Information provided by: | Tissue Repair Company |
ClinicalTrials.gov Identifier: | NCT00493051 |
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.
Condition | Intervention | Phase |
---|---|---|
Diabetic Foot |
Biological: GAM501 Biological: Placebo Other: Standard of care |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 210 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
Standardized Wound Care
|
Other: Standard of care
moist dressing changes daily
|
2: Placebo Comparator
Placebo 1 dose
|
Biological: Placebo
Collagen gel
|
3: Placebo Comparator
Placebo 2 doses
|
Biological: Placebo
Collagen gel
|
4: Active Comparator
Active 1 dose
|
Biological: GAM501
Ad5PDGF-B formulated in a collagen gel
|
5: Active Comparator
Active 2 doses
|
Biological: GAM501
Ad5PDGF-B formulated in a collagen gel
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barbara K Sosnowski, Ph.D. | 858-793-6641 ext 575 | bsosnowski@t-r-co.com |
Contact: Danette Powell | 858-793-6641 ext 584 | dpowell@t-r-co.com |
Study Chair: | Jeff Kittrelle, MD | Tissue Repair Company, 6740 Top Gun St, San Diego, CA 92121 USA, 858-259-4511 |
Responsible Party: | Tissue Repair Company ( Barbara Sosnowski/ Chief Operating Officer ) |
Study ID Numbers: | SWHI-03 |
Study First Received: | June 25, 2007 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00493051 |
Health Authority: | United States: Food and Drug Administration |
diabetes nonhealing ulcers neuropathic |
Foot Ulcer Skin Diseases Diabetic Neuropathies Ulcer Diabetes Mellitus Vascular Diseases Endocrine System Diseases |
Diabetic Angiopathies Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Cardiovascular Diseases |