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NCT00013299 Clinical Trial

Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3

Diabetic Foot Ulcers Clinical Trial

Official title:
Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00013299
Other study ID # A2443R
Secondary ID
Status Completed
Phase Phase 2
First received March 14, 2001
Last updated January 20, 2009
Start date October 2000
Est. completion date April 2001

Study information
Verified date January 2001
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 427
Est. completion date April 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Diabetics with foot ulcerations

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Prevention of Diabetic Ulcers

Locations
Country Name City State
United States VAMC, Seattle, WA Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

See also
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Completed NCT00013286 - A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk Phase 2
Terminated NCT02667327 - A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer Phase 3
Not yet recruiting NCT00916292 - Safety Study of Topical Human FGF-1 for Wound Healing Phase 1
Completed NCT01154374 - A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot) Phase 2
Not yet recruiting NCT02672280 - Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects Phase 1/Phase 2