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The CareFUL Prevention Trial (CareFULPrevent)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
DIApedia, LLC
ClinicalTrials.gov Identifier:
NCT00803608
First received: December 4, 2008
Last updated: August 12, 2014
Last verified: August 2014

December 4, 2008
August 12, 2014
February 2009
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00803608 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The CareFUL Prevention Trial
Prospective, Randomized, Multiple Site Clinical Trial Comparing the Effectiveness of Novel Pressure Based Insoles to Current Care For Ulcer Prevention

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Plantar Ulcer
  • Diabetes
  • Neuropathy Causing Loss of Protective Sensation
  • Device: TrueContour® Insole
    Novel designed insole
  • Device: Current standard of care insole
    Current Medicare approved A5513 insole
  • Active Comparator: 02
    Current standard of care insole
    Intervention: Device: Current standard of care insole
  • Experimental: 01
    TrueContour® insole
    Intervention: Device: TrueContour® Insole
Ulbrecht JS, Hurley T, Mauger DT, Cavanagh PR. Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial. Diabetes Care. 2014 Jul;37(7):1982-9. doi: 10.2337/dc13-2956. Epub 2014 Apr 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
December 2013
December 2013   (final data collection date for primary outcome measure)

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. 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00803608
DK05907405A1, R44DK059074
Yes
DIApedia, LLC
DIApedia, LLC
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Joseph L Loomis, MS DIApedia, LLC
DIApedia, LLC
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP