Trial · NCT07910721
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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 |
| Secondary | Assessing the usability of Solsius SelfCare by patients | 12 months | Mean daily step count : Mean number of steps per day recorded by the Solsius SelfCare insoles. Unit: steps/day. Time Frame: 12 months |
| Secondary | Assessing the usability of Solsius SelfCare by patients | 12 months | Adherence to insole use : Percentage of patients adherent to the insole wear protocol. Unit: % of participants. Time Frame: 12 months |
| Secondary | Assessing the usability of Solsius SelfCare by patients | 12 months | Adherence to self-monitoring : Percentage of patients adherent to the self-monitoring protocol. Unit: % of participants. Time Frame: 12 months |
| Secondary | Assessing the usability of Solsius SelfCare by patients | 12 months | 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) |
| Other | Assessing adverse events and effects | 12 months | Number and nature of adverse events/serious adverse events attributable to the DMN (e.g.: injuries related to the insoles) during the follow-up period of the study. |
| Other | Assessing defects | 12 months | Number and nature of system faults (insoles, application) during the follow-up period of the study |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT07910721/registered