The CareFUL Prevention Trial

2014-08-27 03:25:49 | BioPortfolio


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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Plantar Ulcer


True Contour Insole, Standard Insole


Not yet recruiting


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

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:25:49-0400

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Medical and Biotech [MESH] Definitions

Inflammation of the thick tissue on the bottom of the foot (plantar fascia) causing HEEL pain. The plantar fascia (also called plantar aponeurosis) are bands of fibrous tissue extending from the calcaneal tuberosity to the TOES. The etiology of plantar fasciitis remains controversial but is likely to involve a biomechanical imbalance. Though often presenting along with HEEL SPUR, they do not appear to be causally related.

A fibromatosis of the plantar fascia characterized by thickening of the fibrous bands on the plantar aponeurosis in the sole of the foot and toes.

A bony outgrowth on the lower surface of the CALCANEUS. Though often presenting along with plantar fasciitis (FASCIITIS, PLANTAR), they are not considered causally related.


Ulceration of the skin and underlying structures of the lower extremity. About 90% of the cases are due to venous insufficiency (VARICOSE ULCER), 5% to arterial disease, and the remaining 5% to other causes.

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