The CareFUL Prevention Trial (CareFULPrevent)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
DIApedia, LLC
ClinicalTrials.gov Identifier:
NCT00803608
First received: December 4, 2008
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Plantar Ulcer
Diabetes
Loss of Protective Sensation
Device: True Contour Insole
Device: Standard Insole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Prospective, Randomized, Multiple Site Clinical Trial Comparing the Effectiveness of Novel Pressure Based Insoles to Current Care For Ulcer Prevention

Resource links provided by NLM:


Further study details as provided by DIApedia, LLC:

Primary Outcome Measures:
  • The first occurrence of a plantar ulcer or pre-ulcer in subjects who have had one previously healed plantar ulcer [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 286
Study Start Date: February 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 02
Current standard of care insole
Device: Standard Insole
Current SADMERC approved insole
Experimental: 01
True Contour insole
Device: True Contour Insole
Novel designed insole

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women, 18 years of age or older at the time of consent;
  2. Clinical diagnosis of Diabetes Mellitus ;
  3. 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;
  4. Barefoot plantar pressure in the area of the previous MTH-related ulcer or at the area of current hemorrhagic callus >450 kPa;
  5. Loss of Protective Sensation (refer to Section 7.2.6);
  6. 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;
  7. Ability to give consent;
  8. In the opinion of the site PI the subject is willing and able to comply with the scheduled visits, treatment plan, and other trial procedures for the duration of the study.

Exclusion Criteria:

  1. 1. Presence of a current ulcer (see Section 7.1.1) below the malleoli, in the opinion of the site PI;
  2. 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;
  3. 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);
  4. 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;
  5. 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;
  6. 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;
  7. 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
  8. Barefoot plantar pressure in the mid-foot that exceeds forefoot peak plantar pressure;
  9. Need for an ankle-foot orthoses in the opinion of the site PI or another provider;
  10. Need for more complex intervention, i.e. the site PI's decision is that the study footwear would not be adequate for the subject's needs, e.g. a rigid outsole or custom molded shoes are deemed necessary.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803608

Locations
United States, Arizona
Carl T Hayden VA Medical Center
Phoenix, Arizona, United States
Southern Arizona Limb Salvage Alliance
Tucson, Arizona, United States
United States, California
Center for Clinical Research, Inc
Castro Valley, California, United States, 94546
Innovative Medical Technologies
Los Angeles, California, United States
United States, Colorado
Diabetic Foot and Wound Center
Denver, Colorado, United States
United States, Illinois
Weil Foot & Ankle Institute
Des Plaines, Illinois, United States, 60016
Hines VA Hospital
Hines, Illinois, United States, 60141
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States
United States, Pennsylvania
Blair Medical Associates, Inc
Altoona, Pennsylvania, United States, 16602
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Complete Family Footcare
McAllen, Texas, United States, 78501
Sponsors and Collaborators
DIApedia, LLC
Investigators
Principal Investigator: Joseph L Loomis, MS DIApedia, LLC
  More Information

No publications provided

Responsible Party: DIApedia, LLC
ClinicalTrials.gov Identifier: NCT00803608     History of Changes
Other Study ID Numbers: DK05907405A1, R44DK059074
Study First Received: December 4, 2008
Last Updated: September 12, 2013
Health Authority: United States: Federal Government

Keywords provided by DIApedia, LLC:
Plantar
Ulcer
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Ulcer
Foot Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer

ClinicalTrials.gov processed this record on April 17, 2014