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Therapeutic Areas: Endocrinology | Dermatology | Podiatry | Family Medicine
Disease Category: Diabetic Foot Ulcers
Location: United States, PA

Clinical Trial Details

Overview

Research Study Summary

To assess the efficacy of TrueContour Insoles versus the current standard of care insoles in recurrence of plantar 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 foot ulcer (>1 week but <12 weeks since heeling) and have Loss of Protective Sensation.

Purpose

Patient Inclusion Criteria:

  • Men and women, 18 years of age or older at the time of consent;
  • Clinical diagnosis of Diabetes Mellitus;
  • At least one recently healed plantar MTH-related foot ulcer (>1 week but 4 months since heeling), based on medical records or if these cannot be obtained to the subject's best recollection OR current or recurring hemorrhage into callus under at least one MTH in a patient with a prior MTH related plantar ulcer that has been documented in the medical record;
  • Barefoot plantar pressure in the area of the previous MTH-related ulcer or at the area of current hemorrhagic callus >450 kPa;
  • Loss of Protective Sensation
  • Community ambulator defined as having the ability or potential for ambulation outside in the community including the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces, or better by subject report

Patient Exclusion Criteria:

  • Presence of a current ulcer below the malleoli, in the opinion of the site PI;
  • Partial foot amputation greater than of two metatarsal heads or rays per foot; toe amputations with the metatarsal heads left in place are permissible; complete foot amputation on one side (i.e. ambulation with a prosthesis) is permissible; A prior ulcer on the plantar aspect of the foot associated with a mid-foot prominence at any time in the past, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;
  • A prior ulcer on the plantar aspect of the foot associated with a mid-foot prominence at any time in the past, if the associated plantar pressure is >450kPa;
  • Barefoot plantar pressure in the mid-foot that exceeds forefoot peak plantar pressure;
  • Charcot process that is active in the opinion of the site PI (requires immobilization beyond use of footwear that would be available through the study);
  • A prior ulcer on the plantar aspect of the heel within the last year, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear;
  • A prior ulcer on the weightbearing aspect of any toe within the last year, to the subject's best recollection that in the opinion of the site PI has high probability of recurring in the study footwear

To Learn more
Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Facility Type

N/A

Contact

Julia Benton, RN, CCRC, Site Manager
Blair Medical Associates, Inc. Clinical Trials Dept.
Station Medical Center
1414 Ninth Ave
Altoona, PA 16602
Phone: 814-946-7569
Fax: 814-949-1966

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 180462

Date Last Changed: July 19, 2013


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