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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00034788 |
The purpose of this study is to evaluate the efficacy and safety of REGRANEX® Gel compared with placebo when applied for up to 52 consecutive weeks to recurring or non-healing ulcers of the ankle or foot related to diabetes.
Condition | Intervention | Phase |
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Foot Ulcer Diabetic Foot Skin Ulcer Diabetic Neuropathies |
Drug: Becaplermin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Clinical Evaluation of the Efficacy and Safety of REGRANEX® Gel in the Long-Term Treatment and Re-Treatment of Lower Extremity Diabetic Ulcers |
Study Start Date: | December 2000 |
Study Completion Date: | February 2004 |
This study has an initial open-label treatment period of up to 20 weeks with REGRANEX® gel for ulcers of the ankle or foot related to diabetes mellitus. Gel is applied once a day in a thin layer to cover the entire surface of the ulcer; then a non-adherent dressing and gauze are used to cover the gel. If all ulcers are healed during this open-label period, and if they remain healed after 24 weeks of observation, the patient discontinues the study. If one or more ulcers are not healed during the 20 weeks, of if an ulcer recurs or a new ulcer is observed during up to 24 weeks of observation, then the patient enters Double-blind Phase #1 during which neither the patient nor the physician knows whether the study drug or placebo is being applied to the ulcer. This Phase
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR003238 |
Study First Received: | May 2, 2002 |
Last Updated: | July 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00034788 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Regranex Foot ulcers Diabetes Diabetes mellitus Diabetic foot |
Foot Ulcer Diabetic Neuropathies Skin Diseases Ulcer Vascular Diseases Diabetes Mellitus Endocrine System Diseases Foot Diseases Diabetic Angiopathies |
Neuromuscular Diseases Peripheral Nervous System Diseases Platelet-derived growth factor BB Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Foot Ulcer Diabetic Neuropathies Skin Diseases Ulcer Nervous System Diseases Vascular Diseases Diabetes Mellitus Endocrine System Diseases Foot Diseases |
Diabetic Angiopathies Pathologic Processes Neuromuscular Diseases Peripheral Nervous System Diseases Cardiovascular Diseases Skin Ulcer Diabetes Complications Leg Ulcer Diabetic Foot |