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

NCT ID: NCT05074849

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-10-20
• Study Completion Date: 2026-12-30

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.

Detailed Description

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 by devices ineffective in reducing pressure in certain areas of the foot. Foot care education by clinicians regarding adherence to prescribed footwear is not effective in reducing the initial and recurrent DFUs.

A recent study by Najafi and colleagues demonstrated the efficacy and feasibility of smart insoles with real-time alerts for plantar pressure offloading, which causes more than 50% of pressure ulcers in at-risk individuals with diabetes. The device was designed to cue offloading to manage unprotected sustained plantar pressures to prevent foot ulceration. Interestingly, their study suggested that in the group with at least 1 alert every 2 hours, adherence to prescribed footwear was increased or retained over time; whereas a lower number of alerts reduced adherence. Authors speculated that reduced adherence in the low-alert group may be linked to disengagement or reduced perception of benefit. It is unknown whether smart insoles with alerts will improve the use of footwear and lower the incidence of DFU, compared to usual care and the role of self-efficacy in mediating among performance, desired behavior, and desired outcomes (increase adherence to diabetic footwear and decrease the incidence of foot ulcer) among participants in the proposed study. To fill the gaps, investigators aim to examine whether integration of a diabetes foot self-care education and smart insoles with alerts may sustain adherence, irrespective of several daily alerts, to prescribed footwear, compared to usual care in those at risk for DFU.

In this study (R21) phase, investigators are proposing a randomized controlled trial to evaluate the efficacy of insoles with real-time alert and foot self-care education in improving adherence to prescribed footwear in diabetes patients at risk for DFU. In Aim 1, investigators will examine whether smart insoles with real-time alert components plus foot self-care education compared to the smart insole with alerts alone and usual care will improve adherence to prescribed footwear in high-risk individuals for DFU (history of neuropathy and peripheral artery disease [PAD]). In Aim 2, investigators will examine trends across groups in the incidence of initial and recurrent DFU.

The overall goal is to generate data for an R01 submission to evaluate the effectiveness of combined smart insoles with real-time alert plus foot self-care education in preventing the incidence of initial and recurrent DFU in those at-risk individuals with diabetes.

Conditions

Diabetes Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Smart insoles + Education

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)

Group Type: EXPERIMENTAL

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

Intervention Type: 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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Woman's University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ngozi Mbue

Role: PRINCIPAL_INVESTIGATOR

Texas Woman's University

Locations

Baylor College of Medicine

Houston, Texas, United States

Texas Woman's University

Houston, Texas, United States

Countries

United States

Central Contacts

Ngozi Mbue, PhD

Role: CONTACT

nmbue@twu.edu

7137942892

Bijan Najafi, PhD

Role: CONTACT

bijan.najafi@bcm.edu

7137981158

Other Identifiers

RDK122264A

Identifier Type: -

Identifier Source: org_study_id