Benefits of Insoles With Real-Time Alert and Foot Self-Care Education
Sponsored by Texas Woman's University
About this study
Novel approaches to promote adherence to diabetic footwear and prevent high incidence of diabetes foot ulcers are urgently needed. Investigators propose to translate an innovative and practical technology to supplement clinical and risk evaluation for patients with diabetes through wearable insoles and smart watch, along with foot self-care education, to improve adherence to prescribed footwear and reduce incidence of foot ulcers in those with diabetes and at risk for foot ulcers.
Uncontrolled diabetes is the cause of diabetes-related limb amputations. Diabetes-related amputations are huge problems, expensive to manage, and affect the quality of life. Diabetes foot ulcers (DFU) are foot-related injuries to the foot that are a direct result of neuropathy and peripheral artery diseases and have been identified as major risk factors for amputations. To prevent DFU, diabetes footwear is recommended, however, adherence is poor. Patients are not routinely adherent to the recommended diabetic footwear. In addition, current diabetic footwear is not effective in preventing most initial and recurrent DFUs. Although the causal mechanisms for DFU are multi-factorial, evidence exists that elevated plantar pressure contributes to the development of DFU, which is currently managed…
Where this study is enrolling (2)
- I'm interested
Baylor College of Medicine
Houston, Texas
- I'm interested
Texas Woman's University
Houston, Texas
Who can participate
Inclusion criteria
- ✓Men or women 18 years old or older,
- ✓Diagnosis of Diabetes Mellitus,
- ✓Ambulatory, Uses prescribed diabetes footwear.
- ✓Those willing and able to attend follow up visits such as long distance (i.e. greater than 30 miles to recruitment sites).
- ✓Those able to read or follow directions.
Exclusion criteria
- ✕Active Charcot Arthropathy or major foot deformity,
- ✕Cardiopulmonary disease (e.g. recent MI, Stroke),
- ✕Gangrene, active infection. Montreal Cognitive Assessment (MOCA\<20).
- ✕Wide spread malignancy or systemically immunocompromising disease.
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Trial data sourced from ClinicalTrials.gov.