Diabetes ComplicationsNCT05074849
Benefits of Insoles With Real-Time Alert and Foot Self-Care Education
A study testing A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion in people with Diabetes Complications, run by Texas Woman's University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Complications
- What is being tested?
- A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Oct 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030
Texas Woman's University
Houston, Texas, 77030
About this study
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
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.
Read the 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
- Being tested
- A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months, 4 months and 6 months
Secondary outcomes (3)
A change in Response Rate to Alert and Unreported Alert Duration is being assessed
Successful response rate to alert and unreported alert will be assessed. Participants will report either low or high adherence to alert and duration. Investigators will report number of low and high alerts periods and activities.
Measured: 2 months, 4 months and 6 months
A change in Foot Self-Care knowledge is being assessed
Improved in foot self-care knowledge and will be assessed with Foot Self-Care Knowledge and Practice which has 15 questions on knowledge and 15 questions for practice. Cronbach's alpha for the knowledge scale is 0.79, and practice is 0.72.
Measured: Baseline and 6 months
A change in Perception of Benefits is being assessed
User perception of benefits (Tech, Acceptance, Model). Participants will provide information on how strongly they agree or disagree with statements regarding benefits, acceptability, and ease of the wearable device on a 5-point scale: 1) strongly disagree; 2) somewhat disagree; 3) neutral; 4) somewhat agree; and 5) strongly agree. An average of 4 or higher indicates successful achievement on the TAM.
Measured: 2 months, 4 months and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start20 Oct 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ngozi Mbue, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074849
- Sponsor's protocol ID
- RDK122264A
- Status last verified
- Apr 2025
- First submitted
- 13 Aug 2021
- Last updated
- 16 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05074849
- Acronym / sponsor ID
- RDK122264A
- Conditions
- Diabetes Complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smart insoles + Education | Experimental | Behavioral: A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussionParticipants 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) |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussionA 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). | Behavioural | Smart insoles + Education |
Primary outcome
A Change in Adherence to prescribed footwear is being assessed
Time frame: 2 months, 4 months and 6 months
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.
3 secondary outcomes
A change in Response Rate to Alert and Unreported Alert Duration is being assessed
Time frame: 2 months, 4 months and 6 months
A change in Foot Self-Care knowledge is being assessed
Time frame: Baseline and 6 months
A change in Perception of Benefits is being assessed
Time frame: 2 months, 4 months and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ngozi Mbue principal investigator
Texas Woman's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion in people with Diabetes Complications, run by Texas Woman's University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ngozi Mbue, PhD (7137942892, nmbue@twu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Change in Adherence to prescribed footwear is being assessed (time frame: 2 months, 4 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.