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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevention of Diabetic Ulcers | Device |
Diabetics with foot ulcerations
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| Name | Affiliation | Role |
|---|---|---|
| John Fryer, Ph.D. Asst. Director | Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service | |
| Wijegupta Ellepola, Program Analyst | Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VAMC, Seattle, WA | Seattle | Washington | United States |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D016523 | Foot Ulcer |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D005534 | Foot Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |