This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology (NCT05968924), a na na study. The primary outcome is Adherence to Use of SmartMat.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05968924 |
| Phase | NA |
| Condition | Diabetic Foot Ulcer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Montefiore Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns participants with diabetes and high risk of diabetic foot ulceration. The registry record lists diabetic foot ulcer as the condition and describes a high-risk diabetic foot ulcer group. It does not report detailed eligibility criteria or further characteristics of participants, so the exact clinical profile of the cohort cannot be established from the record.
Intervention
Participants used the Podimetrics SmartMat, a foot mat described as detecting changes in foot temperature that may predict foot ulceration. The study focused on adherence to use of the device over a period of up to six months after the intervention. Automated data collection was to quantify foot scans.
Comparator
No comparison group is registered. The trial is listed as single-group, with allocation recorded as NA. Accordingly, the design does not provide a like-for-like control group for separating device use from other influences on scanning behavior or health care use.
Primary question
The primary question is how frequently participants used the SmartMat, measured as the median number of foot scans per week over the follow-up period. The registry defines adherence as conducting foot scans on more than 3 days per week. The primary result needed to answer how much scanning occurred, including its spread across participants, is not reported in the registry record.
In practical statistical terms, this is a feasibility and use question rather than a randomized comparison of health outcomes. The registry also lists use of health care facilities and occurrence of diabetic foot ulcer as secondary outcome topics. Those topics could provide context about events during follow-up, but without reported outcome estimates and a comparator they cannot establish whether the device changed those outcomes. The record identifies the device as FDA cleared; that status does not replace the need to examine the trial’s own outcome data when interpreting its findings.
3. Trial Design
NCT05968924 is registered as a single-group study sponsored by Montefiore Medical Center. The record lists an enrollment of 20 participants and a completed status. The recorded start date is 2024-07-03 and the primary completion date is 2025-04-03. The phase is listed as NA, allocation as NA, and masking as none. The study arm is described as high risk diabetic foot ulcer, with the Podimetrics SmartMat as the intervention.
Because there is only one registered group, the design is not a randomized comparison and does not include a like-for-like control arm. The absence of masking means the record does not describe blinded use or assessment. These design features matter particularly for an adherence endpoint: participants know whether they are using the mat, and there is no parallel group in the record against which to distinguish device-specific behavior from changes that might occur over time or through other influences.
The study summary describes monitoring adherence to a non-significant-risk device over six months. The primary outcome timeframe is stated as up to six months following the intervention. The intervention is a foot mat that records scans and detects temperature changes; the registry describes temperature changes as potentially predictive of ulceration, rather than reporting that prediction as a trial result.
The registry lists four outcome measures and zero analyses. It identifies use of health care facilities and occurrence of diabetic foot ulcer as secondary outcome topics, but does not report their estimates in the registry record for interpretation. Detailed eligibility criteria, the number of participants who completed follow-up, the handling of incomplete device records, and the statistical analysis plan are not reported in the registry record. The stated enrollment therefore describes the registered study size, not necessarily the number with complete primary outcome data.
A sample-size illustration based on an observed effect is not the study’s design or a record of a control group. Its assumptions describe a hypothetical two-arm planning framework, whereas this trial is registered as single-group. No sample-size justification for the actual single-group study is reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | High Risk Diabetic Foot Ulcer (DFU) |
|---|---|
| STARTED | 20 |
| COMPLETED | 19 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | High Risk Diabetic Foot Ulcer (DFU) |
|---|---|
| Death | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | High Risk Diabetic Foot Ulcer (DFU) |
|---|---|---|
| Participants analysed | 20 | |
| Age, Continuous | years | 62.7 (SD 8.0) |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 17 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 8 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 9 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 3 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 12 |
| Race (NIH/OMB): White | Participants | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 |
| Region of Enrollment: United States | Participants | 20 |
6. Primary Endpoint
The registry lists the primary outcome as Adherence to Use of SmartMat, measured over Up to six months following intervention.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | number of foot scans/week |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is adherence to SmartMat use, expressed as the median number of foot scans per week over up to six months following the intervention. The registry states that adherence is defined as conducting foot scans on more than 3 days per week during the six-month period. Automated data collection is identified as the source for quantifying use.
This measure addresses whether participants repeatedly used the device, a practical question for a monitoring technology whose operation depends on participants scanning their feet. It is distinct from an outcome such as ulcer occurrence: scan frequency describes device use, not whether an ulcer was prevented, detected, or treated earlier. The registry separately lists ulcer occurrence and use of health care facilities as secondary outcome topics.
The median gives a central summary of participants’ scan frequency while being less influenced by unusually high or low values than an arithmetic mean. The interquartile range, the stated measure of dispersion, describes the spread of the middle portion of the observations. In general, reporting both helps distinguish a typical frequency from variation across participants.
The adherence definition and the reported endpoint are related but not identical summaries. A median number of scans per week does not by itself state how many participants met the criterion in each week or across the full follow-up period. Those participant-level adherence results, as well as the median and interquartile range themselves, are not reported in the registry record. Consequently, the endpoint is defined, but its observed value and distribution cannot be interpreted.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the question and measurement approach: participants in a single high-risk diabetic foot ulcer group were to use the SmartMat, with automated records used to quantify scans. The primary measure is the median weekly scan frequency over up to six months. The record defines adherence using scanning on more than 3 days per week. These details make the intended measure understandable, but they are not themselves evidence about the level of adherence achieved.
No primary endpoint estimate is reported in the registry record. In particular, the median number of scans per week and its interquartile range are not reported. There is therefore no posted estimate of typical scanning frequency, no measure of how widely scan frequency varied, and no basis for judging how many participants satisfied the stated adherence criterion. The absence of an estimate should not be interpreted as zero scans, poor adherence, or an unsuccessful study; it means the result is not reported in the registry record.
The record lists zero analyses. It also identifies four outcome measures, including the primary adherence measure and secondary topics of health care facility use and diabetic foot ulcer occurrence. The stated number of outcomes does not substitute for results: estimates and analysis details for these outcomes are not reported in the registry record. The study’s completed status indicates its registry status, but it does not establish that results have been posted or that every enrolled participant contributed complete data.
General statistical interpretation: an estimate is most useful when considered together with its uncertainty and the amount of observed data supporting it. For this endpoint, the interquartile range would describe dispersion, but it is not a confidence interval and does not by itself quantify uncertainty in the estimated median. No confidence interval or other uncertainty estimate for the primary outcome is reported in the registry record. Thus, even if a central value were available, precision could not be assessed from the listed record alone.
The single-group design also limits what can be inferred. A description of scanning in the enrolled cohort could characterize device use in that group, but there is no registered control group for estimating what scanning behavior or clinical outcomes would have been without the device. The study does not support a controlled causal comparison based on the design information in the registry record. Any secondary outcome counts would also need their definitions, follow-up completeness, and analysis context before they could be interpreted as evidence about changes in health care use or ulcer occurrence.
The adverse-event record includes event figures for the high-risk group, but those entries do not fill the gap in the primary efficacy or adherence result. The serious-event and other-event counts, the hospitalization term, and the death entry are safety information with their own limitations, including the lack of reported attribution and detailed event context. They should not be read as a substitute for scan-frequency results.
Overall, the posted record supports a narrow conclusion about study structure and measurement: a completed, single-group device-use study was registered, and adherence was to be quantified from automated scan data. It does not provide the numerical primary result, precision estimates, or comparative evidence needed to characterize the observed adherence or relate it to clinical outcomes. The trial’s record therefore describes what was intended to be measured, not the magnitude or reliability of the observed result.
9. Statistical Methods Explained
The registry defines an endpoint and a descriptive summary, but does not report an analysis result. The following concepts are general statistical explanations of how such measures are ordinarily understood; they do not imply that any particular analysis was performed in this study.
What does a median summarize?
In general, the median is the value at the center of an ordered set of observations. It is often useful when a measure can be skewed or include unusually large values, because the median is less sensitive to extreme observations than the mean. For the registered endpoint, the target summary is the median number of foot scans per week over the follow-up period. Without the observed median, it is not possible to state the typical scan frequency in this cohort.
The median is a summary, not a complete description of individual behavior. Different patterns across participants can produce the same median. A group could have values clustered near the center or a much broader spread; the median alone would not distinguish those patterns. The registry specifies the interquartile range as the dispersion measure, which is intended to add information about spread.
What does the interquartile range convey?
In general, the interquartile range describes the interval spanning the middle half of observations. It is a descriptive measure of dispersion: a narrower interval indicates less spread in that central portion, while a wider interval indicates greater spread. It does not show the full range, identify unusual values, or tell how precisely the median has been estimated. It is also not the same as a confidence interval. The registry record does not report the interquartile range for scan frequency.
That distinction is important when reading a result. Dispersion describes how participant observations differ from one another; precision describes uncertainty about a population-level estimate. A confidence interval is a general tool for expressing uncertainty under a statistical model and analysis procedure. The record does not report a confidence interval for the primary endpoint, so the precision of the median cannot be assessed from the registry result information.
How does the adherence criterion relate to the median?
The record defines adherence as conducting foot scans on more than 3 days per week over the six-month period, while specifying the median number of scans per week as the reported primary measure. These summarize use in different ways. A frequency median describes a central scan count; a threshold criterion classifies behavior relative to a stated minimum number of scanning days. One does not automatically reveal the other. In general, a report could add the number or proportion of participants meeting a criterion, but that result is not reported in the registry record.
The wording also makes the unit relevant: the primary endpoint is a number of scans per week, while the adherence definition refers to days with scans per week. Scan counts and scanning days are related, but they are not identical quantities. The record’s definition should be retained when interpreting the intended adherence measure rather than treating a scan count as an interchangeable measure of days used.
Why do repeated observations matter?
Automated data collection over an extended follow-up can create repeated observations from the same participant. General statistical principle: observations from one person may be more alike than observations from different people. Analyses that treat all repeated records as independent can understate uncertainty if they do not account for this dependence. The primary measure is described as a six-month median, but the registry record does not detail how weekly records were aggregated, how incomplete weeks were handled, or whether any model for repeated measurements was used.
Missing device records also require careful interpretation. A week with no recorded scan could mean no use, a device or data-transfer issue, or missing information; the available record does not explain how such cases were distinguished. This is a general data-quality issue for automated use measures, not a claim about what happened in this study. The operational rules for incomplete records and participant withdrawal are not reported in the registry record.
What can a single-group design estimate?
In general, a single-group study can describe observations in its enrolled cohort. It cannot, on its own, provide the same comparative estimate as a study with a control group. Without a comparison group, changes over time or patterns of use cannot be separated from all other influences through a between-group contrast. The registered design is single-group and has no registered comparator, so a causal comparison with usual care or another device is not available in this record.
The registry’s sample-size assumptions describe an illustration using equal allocation between two arms, a two-sided significance level of 0.05, and a normal approximation. The assumptions characterize planning illustrations, not the registered trial design; the study is single-group. The assumptions also describe the illustration as based on an observed effect and varying the effect to detect as a stated fraction of that effect. No numerical illustration values or primary observed effect are reported in the registry record. Such planning figures are hypothetical design calculations, not observed power and not evidence that the single-group trial was powered for a particular clinical comparison.
More generally, sample-size calculations depend on assumptions about the effect to detect, variability, analysis, and error rates. A calculation can help plan a study, but it does not establish the result or its precision after data collection. In this record, the enrolled sample is 20; a planning illustration should not be treated as a count of observed outcomes or as proof of adequate precision for the primary measure.
What is not available for evaluating the analysis?
The registry record lists zero analyses and does not report a statistical analysis plan, outcome estimates, confidence intervals, or hypothesis tests for the primary endpoint. It is therefore not possible to assess model choice, handling of outliers, adjustment for covariates, missing-data assumptions, or whether a prespecified analysis was followed. These are not details that can be inferred from the endpoint definition alone. For the same reason, no conclusion about statistical significance can be drawn from the registered design or endpoint description.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists four outcome measures, with adherence to SmartMat use as the primary outcome and use of health care facilities and occurrence of diabetic foot ulcer named as secondary outcome topics. It lists zero analyses. Estimates and inferential results for the primary and secondary outcomes are not reported in the registry record. The record does not describe a multiplicity strategy, such as a plan for controlling the chance of false-positive findings when several outcomes or analyses are examined.
General statistical explanation: when several outcomes are tested, interpreting each result as though it were the only analysis can make chance findings more likely across the overall set. A prespecified hierarchy, adjustment procedure, or emphasis on estimation rather than multiple significance tests can help clarify interpretation. None of those approaches should be attributed to this study without a reported analysis plan.
Missing-data handling is also not reported in the registry record. In particular, the record does not state how incomplete scan records, missed follow-up, withdrawal, or unusable device data were handled. These details matter because the primary measure depends on automated scanning records collected over time. Without the number of participants contributing complete data and the rules for incomplete observations, the enrolled sample size alone does not establish the amount of information available for the endpoint.
The analysis population is not described. It is not reported whether analyses were intended to include all enrolled participants, only participants with device data, or another defined group. No imputation method, sensitivity analysis, or reason for missing observations is reported in the registry record. As a result, the possible influence of incomplete follow-up on the primary estimate cannot be assessed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| High Risk Diabetic Foot Ulcer (DFU) | 6 | 20 | 30.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| High Risk Diabetic Foot Ulcer (DFU) | 1 of 20 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| High Risk Diabetic Foot Ulcer (DFU) | 16 of 20 |
Most frequent serious adverse event terms
| Event term | Organ system | High Risk Diabetic Foot Ulcer (DFU) |
|---|---|---|
| Hospitalization | General disorders | 5 of 20 |
| Hospitalization | Skin and subcutaneous tissue disorders | 1 of 20 |
Most frequent non-serious adverse event terms
| Event term | Organ system | High Risk Diabetic Foot Ulcer (DFU) |
|---|---|---|
| Increased Foot Temperature | Infections and infestations | 12 of 20 |
| Diabetic Foot Ulcer | Skin and subcutaneous tissue disorders | 5 of 20 |
| Pre-ulcerative hyperkeratosis | Skin and subcutaneous tissue disorders | 1 of 20 |
| Osteomyelitis | Infections and infestations | 1 of 20 |
Serious events with the highest arm-level rate: hospitalization (25.0%).
The registry’s adverse-event entry for the high-risk diabetic foot ulcer group lists 20 at risk, 6 affected by serious adverse events, 16 affected by other adverse events, and 1 death. Hospitalization is listed among the top serious event terms with 25.0%. These are the safety figures recorded for the group; the record does not provide event narratives or a detailed account of timing, severity, or attribution.
The hospitalization percentage should be read cautiously. The registry entry does not make its denominator or calculation context explicit in the information available for interpretation. It should not be assumed to mean that 25.0% of participants were hospitalized or that it represents a proportion of all serious events. The record also does not establish that the listed hospitalization events were caused by the device or study procedures.
The serious-event count, other-event count, and death entry are separate registry figures. They should not be added together or treated as mutually exclusive categories without further definitions. The record does not report whether the death was considered related to the intervention, nor does it supply a causal assessment for the adverse events. These entries describe reported safety information but do not, by themselves, establish the cause or comparative risk of an event. There is no control group in the registered design for a comparative safety estimate.
12. What the Result Does, and Does Not, Mean
The registry record gives a clear outline of the intended measure: automated records were to quantify SmartMat use, with the primary endpoint expressed as the median number of scans per week over up to six months. It also supplies an operational adherence definition based on scans on more than 3 days per week. This information helps readers understand what the study set out to measure.
However, the primary median and interquartile range are not reported in the registry record. No reported estimate shows the amount of scanning, the variation in use, or how many participants met the adherence definition. The absence of those results is not evidence that participants did not use the device; it leaves the observed level of use unknown from the posted record.
The record also does not report estimates for the secondary topics of health care facility use or diabetic foot ulcer occurrence. It therefore cannot establish whether those outcomes were more or less frequent, or whether they changed during follow-up. General statistical interpretation: outcome descriptions and outcome results are different kinds of information. A defined outcome explains what would be measured; a numerical estimate is needed to describe what was observed.
The study’s single-group design means that even reported changes or event counts would describe this cohort rather than provide a randomized comparison against a control group. Without a comparator, observed patterns cannot isolate an effect of the device from other possible influences. The record does not report a comparative treatment effect or an analysis supporting causal attribution.
The adverse-event figures are also limited to the registry entries and do not include the context needed to assign causality. The device is described as FDA cleared, but that status and the trial’s completed status do not supply the missing adherence or clinical outcome estimates. The statistically supportable interpretation is therefore about the registered study’s design, endpoint definition, and safety entries—not about the magnitude, precision, or causal meaning of an unreported primary result.
13. Why This Trial Matters Statistically
This study raises a practical statistical question that is distinct from whether a device changes clinical outcomes: can use of a foot-monitoring device be quantified over time in a high-risk cohort? The primary endpoint makes that question explicit by defining scan frequency and a threshold-based adherence criterion. Automated records are relevant because they can capture use without relying solely on participant recall, although the registry does not report how complete or usable those records were.
Adherence is often a necessary part of evaluating a monitoring approach. If a device is intended to be used repeatedly, the frequency and consistency of use can affect how much information it generates. Statistical reporting should therefore clarify both the typical amount of use and its variation, and distinguish a median scan count from the proportion meeting a defined use criterion. The registry defines these concepts but does not report the corresponding estimates.
The single-group design is also important for interpreting the scope of the evidence. It can describe use in the enrolled cohort, but it does not create a controlled contrast for assessing how behavior or clinical outcomes compare with an alternative. That distinction prevents a descriptive adherence measure from being mistaken for evidence of a clinical effect.
For biostatisticians and clinical researchers, the record illustrates why endpoint definitions, analysis populations, missing-data rules, and uncertainty estimates all matter. A precise operational definition is useful, but it is only one part of a complete statistical report. The primary estimate, dispersion, uncertainty, and treatment of incomplete records would be needed to assess how informative the observed adherence data are. The available registry information leaves those parts unreported.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important trial-specific limitation for statistical interpretation is the absence of reported primary outcome results. Although the median scan frequency and interquartile range are specified, neither is reported in the registry record. There is no estimate or uncertainty interval with which to assess the observed adherence level or its precision.
The single-group design provides no like-for-like control comparison. It can describe the registered cohort but cannot, through a between-group contrast, distinguish device-related changes from other influences. Allocation is recorded as NA, and the record lists no comparator. Masking is listed as none.
The sample-size assumptions describe a hypothetical two-arm planning illustration, while the registered study is single-group. The record does not provide a numerical sample-size justification for the actual design. The enrollment is 20, but the number with complete primary endpoint data and the analysis population are not reported.
Other limitations specific to the available record include absent analysis details and absent missing-data rules. It is not reported how incomplete scan weeks, device-data interruptions, or participants without full follow-up were handled. The record also lists four outcome measures but reports zero analyses, leaving secondary outcome estimates unavailable. The adverse-event entries do not provide detailed event descriptions, attribution, or a clear denominator for the hospitalization percentage. These gaps constrain interpretation; they do not establish that the study failed to collect such information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology — NCT05968924.
- Registry record last updated 2026-04-30; status last verified 2026-04.
- Results first posted 2026-04-30.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT05968924, “Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology,” is a completed, single-group study sponsored by Montefiore Medical Center. Enrollment is listed as 20. The recorded start date is 2024-07-03, and the primary completion date is 2025-04-03. Phase and allocation are listed as NA; masking is listed as none.
The intervention is the Podimetrics SmartMat, a foot mat described as detecting temperature changes that may predict ulceration. The primary outcome is the median number of foot scans per week over up to six months, with adherence defined as scans on more than 3 days per week. The record names health care facility use and diabetic foot ulcer occurrence as secondary outcome topics.
The registry reports zero analyses and does not report the primary outcome estimate, its interquartile range, or results for the secondary outcomes. Safety entries list 6 serious adverse-event cases, 16 other adverse-event cases, and 1 death among 20 at risk; hospitalization is listed at 25.0% among the top serious terms. Causal attribution and further event context are not reported in the registry record.