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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00013299 |
Purpose
This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of foot ulcers, and (2) Estimate costs of ulcer prevention using these strategies.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Foot Ulcers |
Device: Prevention of Diabetic Ulcers |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3 |
| Estimated Enrollment: | 427 |
| Study Start Date: | October 2000 |
| Study Completion Date: | April 2001 |
This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of footulcers, and (2) Estimate costs of ulcer prevention using these strategies. Patients from the Seattle VA (n=214) and Group Health Cooperative (n=213) will be randomly assigned to one of two study arms. They are: (1) patients wearing study shoes and premolded polyurethane insoles and (2) the control group of patients wearing their own footwear.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Diabetics with foot ulcerations
Contacts and Locations| United States, Washington | |
| VAMC, Seattle, WA | |
| Seattle, Washington, United States | |
| Investigator: | John Fryer, Ph.D. Asst. Director | Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service |
| Investigator: | Wijegupta Ellepola, Program Analyst | Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service |
More Information
| Study ID Numbers: | A2443R |
| Study First Received: | March 14, 2001 |
| Last Updated: | January 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00013299 History of Changes |
| Health Authority: | United States: Federal Government |
|
Foot ulcers, amputation prevention, diabetes, footwear, insoles |
|
Foot Ulcer Skin Diseases Diabetic Neuropathies Vascular Diseases Diabetes Mellitus Endocrine System Diseases Foot Diseases |
Diabetic Angiopathies Cardiovascular Diseases Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
