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The CareFUL Prevention Trial

NCT00803608 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2014-08-13

No results posted yet for this study

Summary

To assess the efficacy of TrueContour® Insoles versus the current standard of care insoles in recurrence of plantar MTH ulcers in men and women, 18 years of age or older at the time of consent with clinical diagnosis of Diabetes Mellitus type 1 or type 2 who have had at least one recently healed plantar MTH foot ulcer (\>1 week but \<12 weeks since heeling) and have Loss of Protective Sensation.

Conditions

  • Plantar Ulcer
  • Diabetes
  • Neuropathy Causing Loss of Protective Sensation

Interventions

DEVICE

TrueContour® Insole

Novel designed insole

DEVICE

Current standard of care insole

Current Medicare approved A5513 insole

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • DIApedia, LLC

    lead INDUSTRY

Principal Investigators

  • Joseph L Loomis, MS · DIApedia, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00803608 on ClinicalTrials.gov