Diabetic Foot DiseaseDIAFOOTEMNCT07910721
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
A study testing Solsius SelfCare in people with Diabetic Foot Disease and Diabetic Foot Infection, run by Solsius at 3 sites in France.
Trial summary
The goal of this clinical trial is to evaluate the performance of a self-monitoring system (Solsius SelfCare) to detect pre-ulcerative clinical abnormalities in adults living with type 1 or 2 diabetes at high podiatric risk (grade 3 according to French HAS guidelines) and a history of healed diabetic foot wound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Disease, Diabetic Foot Infection, Diabetic Foot Infections
- What is being tested?
- Solsius SelfCare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 10 Mar 2026to 10 Apr 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years or older,
- Patient living with type 1 or type 2 diabetes,
- Patient with a podiatric risk grade of 3 according to Haute Autorité de Santé (HAS) [19],
- Patient with a history of a foot ulcer healed at least 2 months prior to inclusion,
- Patient with an HbA1c or GMI level measured within the last 3 months and below 10%,
- Patient able to walk daily,
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- Patient owning a smartphone equipped with Bluetooth Low Energy 4.1 technology (Android 9 and iOS 15 or later), compatible with the technical requirements of the insoles and able to connect to the internet (via a cellular plan or Wi-Fi),
- Patient willing to install the Solsius SelfCare application and comply with the procedures for using the insoles and participating in the study, Patient considered autonomous by the investigator and able to follow the study protocol,
- Patient affiliated with or benefiting from a Social Security system,
- Patient able to understand or read French,
- Patient wearing shoe sizes 36 to 45.
Who cannot join
- Patient with a foot wound,
- History of major lower limb amputation,
- Patient with acute Charcot foot or active osteomyelitis,
- Patient presenting at baseline with any of the following plantar abnormalities: redness; hyperkeratotic plaques; corns, calluses, or thickened skin; blisters; foot edema; cracks or fissures; nail abnormalities (ingrown, painful, or thickened nails); discharge; interdigital fungal infection; early-stage wound or ulcer,
- Patient with severe cognitive impairment significantly limiting their ability to concentrate and preventing them from following the device usage instructions,
- Adult patients under legal protection measures (guardianship, judicial protection, psychiatric care, or deprived of liberty by judicial or administrative decision),
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- Patient previously enrolled in another interventional clinical study,
- Patient with a serious illness likely to lead to premature discontinuation before the end of the study,
- Pregnant or breastfeeding women.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Hôpital Saint-Vincent de Paul [GHICL]
Lille, 59000
Hélène CATTOIR, +33 3 20 22 50 47, cattoir.helene@ghicl.net
- Recruiting
CHU de Lille
Lille, 59037
Anne VANBERGUE-LIBBREC, +33 3 20 44 42 15, anne.vanbergue@chu-lille.fr
- Not yet recruiting
CHU de Montpellier
Montpellier, 34295
Ariane SULTAN, +33 4 67 33 84 02, a-sultan@chu-montpellier.fr
About this study
Official title: Prevention of Diabetic Foot Ulcers Through Self-monitoring: a Performance Evaluation Study (DIAFOOTEM)
The goal of this clinical trial is to evaluate the performance of a self-monitoring system (Solsius SelfCare) to detect pre-ulcerative clinical abnormalities in adults living with type 1 or 2 diabetes at high podiatric risk (grade 3 according to French HAS guidelines) and a history of healed diabetic foot wound.
The main question it aims to answer is:
Read more
- Can the Solsius SelfCare system detect pre-ulcerative foot abnormalities with a sensitivity of at least 80%, defined as the proportion of temperature threshold exceedances (≥ 2.2°C difference between symmetric plantar sites over 2 consecutive days) confirmed by a clinical abnormality identified by a podiatrist?
There is no comparison group. All participants will use the same device throughout the study.
Participants will:
- Wear the Solsius SelfCare connected insoles daily (except during sleep) for 12 months
- Receive a push notification on their smartphone if a temperature difference ≥ 2.2°C is detected between symmetric sites on both feet over 2 consecutive days
- Attend scheduled podiatric follow-up visits every 3 months (at M3, M6, M9, and M12)
- Attend an additional unscheduled podiatric visit within 24 hours after each temperature alert, to verify the presence or absence of a pre-ulcerative clinical abnormality
- Complete a self-questionnaire after each temperature alert and a usability questionnaire (System Usability Scale) at the end of the study
Read the detailed description
Background
Diabetic foot ulcers affect approximately 18.6 million people worldwide each year and precede 80% of lower limb amputations in people living with diabetes. In France, an estimated 26,700 diabetic patients were hospitalized for a foot wound in 2016, and 8,400 underwent a lower limb amputation. Five-year mortality following a diabetic foot ulcer is estimated at 30.5%. Prevention of foot wounds in high-risk patients is therefore a major public health priority.
Skin temperature variations have been identified as an early warning signal for ulceration risk. A temperature difference greater than 2.2°C between symmetric plantar sites on the left and right foot has been associated with an increased risk of foot wound development. The 2023 International Working Group on the Diabetic Foot (IWGDF) guidelines recommend daily foot temperature monitoring in patients at moderate to high ulceration risk (IWGDF risk grades 2-3), with a clinical consultation advised if the 2.2°C threshold is exceeded on two consecutive days on the same side.
Solsius SAS has developed the Solsius SelfCare system, consisting of a pair of connected insoles embedding plantar temperature sensors and a paired smartphone application. The system automatically detects bilateral plantar temperature differentials and alerts the patient via push notification when the 2.2°C threshold is exceeded according to IWGDF criteria. The device is a CE-marked class I medical device under EU MDR 2017/745.
Study Design
DIAFOOTEM is a prospective, multicenter, single-blind performance evaluation study conducted at three French hospital centers (CHU Montpellier, CHU Lille, and Hôpital Saint-Vincent-de-Paul). The podiatrist assessor is blinded to the temperature data recorded by the device throughout the entire study, ensuring an objective and unbiased clinical evaluation.
Study Procedures
Patients follow their usual care routine and consult their podiatrist if the device detects an abnormal change in temperature.
At each visit, the podiatrist records the presence or absence of the following pre-ulcerative abnormalities on each foot.
Sample Size
A total of 60 patients will be enrolled across the three sites over a 12-month inclusion period, with a 12-month follow-up per patient (total study duration: 24 months).
- Conditions
- Diabetic Foot Disease, Diabetic Foot Infection, Diabetic Foot Infections, Diabete Type 1, Diabetes (DM), Foot
- Being tested
- Solsius SelfCare
- Keywords
- diabetic foot, self-monitoring, connected insoles, temperature monitoring
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solsius SelfCareDevice
Smart insoles incorporating plantar temperature sensors (bilateral measurement), worn daily whilst awake for 12 months. Push notification if the temperature difference between two symmetrical sites is ≥ 2.2°C for two consecutive days.
Class I medical device, CE marked in accordance with MDR 2017/745.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients with stage 3 foot disease | Experimental | Diabetic patients with stage 3 foot complications who wore Solsius SelfCare connected insoles for 12 months, in addition to their standard care Receives: Device: Solsius SelfCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the performance of a self-monitoring system for detecting pre-ulcerative lesions in people living with stage 3 diabetic foot disease.
Sensitivity of the Solsius SelfCare system to detect pre-ulcerative clinical abnormalities confirmed by a podiatrist AND preceded by a temperature threshold exceedance (≥2.2°C between symmetrical foot sites on 2 consecutive days, at least once per day, on the same side). Sensitivity = VP / (VP + FN) × 100.
Measured: 12 months
Secondary outcomes (13)
Assess specificity, positive predictive value (PPV), negative predictive value (NPV) and overall diagnostic accuracy
- Specificity, defined as the proportion of temperature exceedances not confirmed by a clinical abnormality (true negatives) among all non-events
- Positive predictive value (PPV), defined as the probability that a temperature exceedance generated by the system actually corresponds to the presence of a clinical abnormality
- Negative predictive value (NPV), defined as the probability that the absence of a temperature exceedance actually corresponds to the absence of a clinical abnormality
- Overall diagnostic accuracy, defined as the proportion of correct classifications (true positives and true negatives) among all observed outliers
Measured: 12 months
To compare the clinical decisions made by healthcare professionals following instances of elevated temperature identified by the Solsius SelfCare self-monitoring system
- Proportion of patients presenting a clinical abnormality verified by the diabetologist (the study's principal investigator), following a temperature exceedance (based on photographs taken by the podiatrist).
- Proportion of agreement between the assessments made by the podiatrist and those made by the diabetologist.
- Proportion of patients who experienced a temperature exceeding a threshold of 2.2°C, and who reported a cause via a self-administered questionnaire, without the presence of a clinical abnormality verified by the podiatrist.
Measured: 12 months
Assess the temperature differentials measured via Solsius SelfCare
- Percentage of temperature exceedances of a 2.2°C threshold, justified according to the time elapsed between the exceedance of the threshold and the medical consultation: 24 hours - 48 hours - > 48 hours
- Percentage of temperature exceedances at the end of the study, according to the thresholds defined below:
- > 2.2°C
- > 2.75°C
- > 3.2°C
- > 3.75°C
- Total number of occurrences of a temperature difference > 2.2°C and average number per patient at the end of the study
Measured: 12 months
Assessing the risk of developing a diabetic foot ulcer
Proportion of patients with a diabetic foot ulcer during the study follow-up period
Measured: 12 months
Assess the care provided by the healthcare professional following a rise in temperature
Description of the care provided by the podiatrist (or the 'diabetic foot' nurse)
Measured: 12 months
Assess the timeframe for a return to normal
Average time between exceeding the 2.2°C threshold and a return to normal
Measured: 12 months
Assessing the frequency of podiatry appointments
- Rate of podiatry visits, expressed as the number of visits per person-year of follow-up ;
Measured: 12 months
Assessing the usability of Solsius SelfCare by patients
Number of days of insole use : Number of days on which the Solsius SelfCare insoles were worn during the monitoring period, recorded by the device. Unit: days. Time Frame: 12 months
Measured: 12 months
Assessing the usability of Solsius SelfCare by patients
Mean daily insole wear time : Mean number of hours per day the insoles were worn, recorded by the device. Unit: hours/day. Time Frame: 6 and 12 months
Measured: 12 months
Assessing the usability of Solsius SelfCare by patients
Mean daily step count : Mean number of steps per day recorded by the Solsius SelfCare insoles. Unit: steps/day. Time Frame: 12 months
Measured: 12 months
Assessing the usability of Solsius SelfCare by patients
Adherence to insole use : Percentage of patients adherent to the insole wear protocol. Unit: % of participants. Time Frame: 12 months
Measured: 12 months
Assessing the usability of Solsius SelfCare by patients
Adherence to self-monitoring : Percentage of patients adherent to the self-monitoring protocol.
Unit: % of participants. Time Frame: 12 months
Measured: 12 months
Assessing the usability of Solsius SelfCare by patients
System Usability Scale (SUS) score : Usability assessed with the French version of the SUS. The score ranges from 0 to 100, and higher scores indicate better usability. Unit: score on a scale. Time Frame: last study visit (up to 12 months)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start10 Mar 2026
- Primary completion10 Apr 2027 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solsius
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ariane Sultan, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910721
- Sponsor's protocol ID
- 2025-A02522-47
- Acronym
- DIAFOOTEM
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Diabetic Foot Ulcers Through Self-monitoring: a Performance Evaluation Study (DIAFOOTEM)
- ClinicalTrials.gov ID
- NCT07910721
- Acronym / sponsor ID
- DIAFOOTEM / 2025-A02522-47
- Conditions
- Diabetic Foot Disease, Diabetic Foot Infection, Diabetic Foot Infections, Diabete Type 1, Diabetes (DM), Foot
- Keywords
- diabetic foot, self-monitoring, connected insoles, temperature monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SolsiusIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 2 Nov 2026 (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.
The goal of this clinical trial is to evaluate the performance of a self-monitoring system (Solsius SelfCare) to detect pre-ulcerative clinical abnormalities in adults living with type 1 or 2 diabetes at high podiatric risk (grade 3 according to French HAS guidelines) and a history of healed diabetic foot wound.
The main question it aims to answer is:
- Can the Solsius SelfCare system detect pre-ulcerative foot abnormalities with a sensitivity of at least 80%, defined as the proportion of temperature threshold exceedances (≥ 2.2°C difference between symmetric plantar sites over 2 consecutive days) confirmed by a clinical abnormality identified by a podiatrist?
There is no comparison group. All participants will use the same device throughout the study.
Participants will:
- Wear the Solsius SelfCare connected insoles daily (except during sleep) for 12 months
- Receive a push notification on their smartphone if a temperature difference ≥ 2.2°C is detected between symmetric sites on both feet over 2 consecutive days
- Attend scheduled podiatric follow-up visits every 3 months (at M3, M6, M9, and M12)
- Attend an additional unscheduled podiatric visit within 24 hours after each temperature alert, to verify the presence or absence of a pre-ulcerative clinical abnormality
- Complete a self-questionnaire after each temperature alert and a usability questionnaire (System Usability Scale) at the end of the study
Detailed description
Background
Diabetic foot ulcers affect approximately 18.6 million people worldwide each year and precede 80% of lower limb amputations in people living with diabetes. In France, an estimated 26,700 diabetic patients were hospitalized for a foot wound in 2016, and 8,400 underwent a lower limb amputation. Five-year mortality following a diabetic foot ulcer is estimated at 30.5%. Prevention of foot wounds in high-risk patients is therefore a major public health priority.
Skin temperature variations have been identified as an early warning signal for ulceration risk. A temperature difference greater than 2.2°C between symmetric plantar sites on the left and right foot has been associated with an increased risk of foot wound development. The 2023 International Working Group on the Diabetic Foot (IWGDF) guidelines recommend daily foot temperature monitoring in patients at moderate to high ulceration risk (IWGDF risk grades 2-3), with a clinical consultation advised if the 2.2°C threshold is exceeded on two consecutive days on the same side.
Solsius SAS has developed the Solsius SelfCare system, consisting of a pair of connected insoles embedding plantar temperature sensors and a paired smartphone application. The system automatically detects bilateral plantar temperature differentials and alerts the patient via push notification when the 2.2°C threshold is exceeded according to IWGDF criteria. The device is a CE-marked class I medical device under EU MDR 2017/745.
Study Design
DIAFOOTEM is a prospective, multicenter, single-blind performance evaluation study conducted at three French hospital centers (CHU Montpellier, CHU Lille, and Hôpital Saint-Vincent-de-Paul). The podiatrist assessor is blinded to the temperature data recorded by the device throughout the entire study, ensuring an objective and unbiased clinical evaluation.
Study Procedures
Patients follow their usual care routine and consult their podiatrist if the device detects an abnormal change in temperature.
At each visit, the podiatrist records the presence or absence of the following pre-ulcerative abnormalities on each foot.
Sample Size
A total of 60 patients will be enrolled across the three sites over a 12-month inclusion period, with a 12-month follow-up per patient (total study duration: 24 months).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients with stage 3 foot disease | Experimental | Device: Solsius SelfCareDiabetic patients with stage 3 foot complications who wore Solsius SelfCare connected insoles for 12 months, in addition to their standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient aged 18 years or older,
- Patient living with type 1 or type 2 diabetes,
- Patient with a podiatric risk grade of 3 according to Haute Autorité de Santé (HAS) [19],
- Patient with a history of a foot ulcer healed at least 2 months prior to inclusion,
- Patient with an HbA1c or GMI level measured within the last 3 months and below 10%,
Key exclusion criteria (9 listed)
- Patient with a foot wound,
- History of major lower limb amputation,
- Patient with acute Charcot foot or active osteomyelitis,
- Patient presenting at baseline with any of the following plantar abnormalities: redness; hyperkeratotic plaques; corns, calluses, or thickened skin; blisters; foot edema; cracks or fissures; nail abnormalities (ingrown, painful, or thickened nails); discharge; interdigital fungal infection; early-stage wound or ulcer,
- Patient with severe cognitive impairment significantly limiting their ability to concentrate and preventing them from following the device usage instructions,
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 |
|---|---|---|
| Solsius SelfCareSmart insoles incorporating plantar temperature sensors (bilateral measurement), worn daily whilst awake for 12 months. Push notification if the temperature difference between two symmetrical sites is ≥ 2.2°C for two consecutive days. Class I medical device, CE marked in accordance with MDR 2017/745. | Device | Diabetic patients with stage 3 foot disease |
Primary outcome
To evaluate the performance of a self-monitoring system for detecting pre-ulcerative lesions in people living with stage 3 diabetic foot disease.
Time frame: 12 months
Sensitivity of the Solsius SelfCare system to detect pre-ulcerative clinical abnormalities confirmed by a podiatrist AND preceded by a temperature threshold exceedance (≥2.2°C between symmetrical foot sites on 2 consecutive days, at least once per day, on the same side). Sensitivity = VP / (VP + FN) × 100.
13 secondary outcomes
Assess specificity, positive predictive value (PPV), negative predictive value (NPV) and overall diagnostic accuracy
Time frame: 12 months
To compare the clinical decisions made by healthcare professionals following instances of elevated temperature identified by the Solsius SelfCare self-monitoring system
Time frame: 12 months
Assess the temperature differentials measured via Solsius SelfCare
Time frame: 12 months
Assessing the risk of developing a diabetic foot ulcer
Time frame: 12 months
Assess the care provided by the healthcare professional following a rise in temperature
Time frame: 12 months
Assess the timeframe for a return to normal
Time frame: 12 months
Assessing the frequency of podiatry appointments
Time frame: 12 months
Assessing the usability of Solsius SelfCare by patients
Time frame: 12 months
Assessing the usability of Solsius SelfCare by patients
Time frame: 12 months
Assessing the usability of Solsius SelfCare by patients
Time frame: 12 months
Assessing the usability of Solsius SelfCare by patients
Time frame: 12 months
Assessing the usability of Solsius SelfCare by patients
Time frame: 12 months
Assessing the usability of Solsius SelfCare by patients
Time frame: 12 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 2 Nov 2026.
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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.
Ariane Sultan principal investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solsius SelfCare in people with Diabetic Foot Disease and Diabetic Foot Infection, run by Solsius at 3 sites in France.
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 11 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 Rodolphe Renault (+33 6 60 78 21 12, a-sultan@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the performance of a self-monitoring system for detecting pre-ulcerative lesions in people living with stage 3 diabetic foot disease. (time frame: 12 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 2 Nov 2026.