Status:
COMPLETED
The CareFUL Prevention Trial
Lead Sponsor:
DIApedia, LLC
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Plantar Ulcer
Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 cl...
Eligibility Criteria
Inclusion
- 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 (refer to Section 7.2.6);
- 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;
- Ability to give consent;
- 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
- Presence of a current ulcer (see Section 7.1.1) 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;
- 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;
- 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;
- Need for an ankle-foot orthoses in the opinion of the site PI or another provider;
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00803608
Start Date
February 1 2009
End Date
December 1 2013
Last Update
August 13 2014
Active Locations (11)
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1
Carl T Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
2
Southern Arizona Limb Salvage Alliance
Tucson, Arizona, United States, 85711
3
Center for Clinical Research, Inc
Castro Valley, California, United States, 94546
4
Innovative Medical Technologies
Los Angeles, California, United States, 90024