Clinical trial NCT05074849: Benefits of Insoles With Real-Time Alert and Foot Self-Care Education
Official title: Benefits of Insoles With Real-Time Alert and Foot Self-Care Education in Improving Adherence for Prescribed Footwear in Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Complications
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: A Change in Adherence to prescribed footwear is being assessed
timeFrame: 2 months, 4 months and 6 months
Secondary outcomes:
measure: A change in Response Rate to Alert and Unreported Alert Duration is being assessed
timeFrame: 2 months, 4 months and 6 months
measure: A change in Foot Self-Care knowledge is being assessed
timeFrame: Baseline and 6 months
measure: A change in Perception of Benefits is being assessed
timeFrame: 2 months, 4 months and 6 months.
Other outcomes:
measure: A change in Adherence to device wear is being assessed
timeFrame: 2 months, 4 months and 6 months
measure: A change in Foot Ulcers is being assessed
timeFrame: Baseline and 6 months
measure: A change in Off loading is being assessed
timeFrame: 2 months, 4 months, and 6 months
measure: A change in Acceptability and Ease of Use is being assessed
timeFrame: 2 months, 4 months and 6 months
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Texas Woman's University
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Ngozi Mbue
role: PRINCIPAL_INVESTIGATOR
References: