Benefits of Insoles With Real-Time Alert and Foot Self-Care Education

NCT05074849 | Not Yet Recruiting

• 1 other identifier: RDK122264A
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetes Complications

Outcome Measures

Primary Outcomes (1)

• A Change in Adherence to prescribed footwear is being assessed

  Daily adherence will be track by Sensor Data and Self-Report Questionnaire. The real-time alert component of the smart insoles will be measured by the tagging of patients' diabetes shoes by Orthimeter (Germany). The system has 1-year battery life and enables continuous measuring adherence to footwear by measuring temperature. Participants will be required to record number of days adhered to footwear or alerts.

  2 months, 4 months and 6 months

Secondary Outcomes (3)

• A change in Response Rate to Alert and Unreported Alert Duration is being assessed

  2 months, 4 months and 6 months

• A change in Foot Self-Care knowledge is being assessed

  Baseline and 6 months

• A change in Perception of Benefits is being assessed

  2 months, 4 months and 6 months.

Other Outcomes (4)

• A change in Adherence to device wear is being assessed

  2 months, 4 months and 6 months

• A change in Foot Ulcers is being assessed

  Baseline and 6 months

• A change in Off loading is being assessed

  2 months, 4 months, and 6 months

Study Arms (3)

Smart insoles + Education

EXPERIMENTAL

Participants in this group will receive a 90-minute group session education on foot self-care strategies (daily foot hygiene and cleanliness, foot protection, use of insoles and smart watch)

Behavioral: A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion

Smart Insoles

NO INTERVENTION

Participants in this group will not receive a 90-minute group session education on foot self-care, but will receive foot care supplies, insoles and smart watch

Usual Care

NO INTERVENTION

Participants will not receive foot self-care education or the use of insoles and smart watch.

Interventions

A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion BEHAVIORAL

A 90-minute group session to educate patients on foot self-care strategies (daily foot hygiene and cleanliness, foot protection, use of insoles and smart watch). Follow-up Care: A biweekly 30-minute one-on-one follow-up phone discussion (i.e., daily foot hygiene and cleanliness, foot protection, use of insoles and smart watch, addressing feedback and questions regarding the intervention and prevention of foot-related complications).

Smart insoles + Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Woman's University: lead

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Texas Woman's University

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Ngozi Mbue

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ngozi Mbue, PhD

CONTACT

7137942892; nmbue@twu.edu

Bijan Najafi, PhD

CONTACT

7137981158; bijan.najafi@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: October 12, 2021
• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)