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

NCT ID: NCT00013299

Last Updated: 2009-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

427 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2001-04-30

Brief Summary

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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.

Detailed Description

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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 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.

Conditions

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Diabetic Foot Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Prevention of Diabetic Ulcers

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Diabetics with foot ulcerations
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Principal Investigators

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John Fryer, Ph.D. Asst. Director

Role:

Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service

Wijegupta Ellepola, Program Analyst

Role:

Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service

Locations

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VAMC, Seattle, WA

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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A2443R

Identifier Type: -

Identifier Source: org_study_id

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