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

NCT00013299 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 427

Last updated 2009-01-21

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcers

Interventions

DEVICE

Prevention of Diabetic Ulcers

Sponsors & Collaborators

Principal Investigators

  • 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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-10-31
Completion
2001-04-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00013299 on ClinicalTrials.gov