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| Tracking Information | |||||||||
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| First Received Date † | March 14, 2001 | ||||||||
| Last Updated Date | January 20, 2009 | ||||||||
| Start Date † | October 2000 | ||||||||
| Current Primary Outcome Measures † | |||||||||
| Original Primary Outcome Measures † | |||||||||
| Change History | Complete list of historical versions of study NCT00013299 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3 | ||||||||
| Official Title † | Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3 | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||||||
| Condition † | Diabetic Foot Ulcers | ||||||||
| Intervention † | Device: Prevention of Diabetic Ulcers | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 427 | ||||||||
| Completion Date | April 2001 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Diabetics with foot ulcerations |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00013299 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Department of Veterans Affairs | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | January 2001 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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