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Sponsors and Collaborators: |
Southern California Institute for Research and Education Heritage Medical Research Institute |
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Information provided by: | Southern California Institute for Research and Education |
ClinicalTrials.gov Identifier: | NCT00446472 |
The objective of this study is to compare the effectiveness and safety of windowed casts with Regranex® (topical becaplermin gel) versus placebo (inactive medication) for treatment of diabetic ulcers on the legs and feet.
Condition | Intervention |
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Diabetic Foot Ulcers |
Drug: Regranex® Drug: Hydrogel |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of Windowed Casts With and Without Regranex® Gel for Healing |
Estimated Enrollment: | 60 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Randomized to Regranex gel
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Drug: Regranex®
Regranex gel will be used for a total of 16 weeks
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2: Active Comparator
Placebo hydrogel will be used for a total of 16 weeks
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Drug: Hydrogel
Placebo hydrogel will be applied for 16 weeks
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Management of diabetic leg or foot ulcers is based on certain principals: 1) effective off-loading of pressure on the wound via specialized shoes, cast braces, or casts, 2) removal of infected or necrotic tissue vial surgery or non-surgical methods, and 3) optimization of wound healing by interventions that promote wound repair such as nutritional support, provision of optimal moisture balance and growth factor therapy.
Application of casts or cast braces [below knee, removable boots with protective padding] to protect and immobilize the ankle and foot have been demonstrated to provide superior wound healing than less cumbersome types of shoe gear (1-3). The benefit of casting may be the result of more effective off-loading of pressure than can be achieved with other devices, but the inability of patients to remove their casts also appears to an important factor, as non-compliance with removable cast-braces has been shown to be a pervasive and significant issue (4,5). One critical concept in diabetic foot ulcer management is the relation between chronically and limb loss — for each year a wound persists, a patient has a 25% risk for major amputation due to complications from infection (6-8). Limb loss has a profound effect on Diabetics' quality of life and rate of lower limb loss among diabetics is four per 1,000 person years in comparison with three per 10,000 person years (9-10).
Ages Eligible for Study: | 21 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presence of one or two ulcers in lower extremities
Exclusion criteria:
United States, California | |
VA Long Beach Healthcare System | |
Long Beach, California, United States, 90822 | |
VA Greater Los Angeles Healthcare System | |
Los Angeles, California, United States, 90073 |
Principal Investigator: | Ian Gordon, M.D., Ph.D. | VA Long Beach Healthcare System |
Principal Investigator: | Aksone Nouvong, D.P.M. | VA Greater Los Angeles Healthcare System |
Responsible Party: | VA Long Beach Health Care System ( Ian Gordon, M.D. ) |
Study ID Numbers: | #778 |
Study First Received: | March 8, 2007 |
Last Updated: | August 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00446472 History of Changes |
Health Authority: | United States: Institutional Review Board |
diabetes mellitus diabetic neuropathies peripheral vascular diseases |
Foot Ulcer Peripheral Vascular Diseases Diabetic Neuropathies Skin Diseases Ulcer Vascular Diseases Diabetes Mellitus Endocrine System Diseases Foot Diseases |
Diabetic Angiopathies Platelet-derived growth factor BB Mitogens Angiogenesis Inducing Agents Endocrinopathy Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Foot Ulcer Diabetic Neuropathies Skin Diseases Growth Substances Ulcer Physiological Effects of Drugs Vascular Diseases Diabetes Mellitus Endocrine System Diseases Foot Diseases Pharmacologic Actions |
Diabetic Angiopathies Pathologic Processes Platelet-derived growth factor BB Angiogenesis Inducing Agents Cardiovascular Diseases Angiogenesis Modulating Agents Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |