Benefits of Insoles With Real-Time Alert and Foot Self-Care Education
ConditionDiabetes Complications
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTexas Woman's University
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion
Treatment groups
72 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov