Trial · NCT07910721
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
NCT07910721, Not applicable, Recruiting, Solsius
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot. Trials, record NCT07910721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07910721
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
- NCT number
- NCT07910721
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Solsius
- Conditions
- Diabetic Foot Disease, Diabetic Foot Infection, Diabetic Foot Infections, Diabete Type 1, Diabetes (DM), Foot
- Interventions
- Solsius SelfCare
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the performance of a self-monitoring system for detecting pre-ulcerative lesions in people living with stage 3 diabetic foot disease. | 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. |
| Secondary | Assess specificity, positive predictive value (PPV), negative predictive value (NPV) and overall diagnostic accuracy | 12 months | * 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 |
| Secondary | To compare the clinical decisions made by healthcare professionals following instances of elevated temperature identified by the Solsius SelfCare self-monitoring system | 12 months | * 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. |
| Secondary | Assess the temperature differentials measured via Solsius SelfCare | 12 months | * 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 |
| Secondary | Assessing the risk of developing a diabetic foot ulcer | 12 months | Proportion of patients with a diabetic foot ulcer during the study follow-up period |
| Secondary | Assess the care provided by the healthcare professional following a rise in temperature | 12 months | Description of the care provided by the podiatrist (or the 'diabetic foot' nurse) |
| Secondary | Assess the timeframe for a return to normal | 12 months | Average time between exceeding the 2.2°C threshold and a return to normal |
| Secondary | Assessing the frequency of podiatry appointments | 12 months | \- Rate of podiatry visits, expressed as the number of visits per person-year of follow-up ; |
| Secondary | Assessing the usability of Solsius SelfCare by patients | 12 months | 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 |
| Secondary | Assessing the usability of Solsius SelfCare by patients | 12 months | 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07910721
GET https://conductscience.org/api/trials/v1/NCT07910721/registered