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 A Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer (NCT06540170), a na na study. The primary outcome is Feasibility of Recruiting and Retaining.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06540170 |
| Phase | NA |
| Condition | Foot Ulcer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 29 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Healthcare Group Polyclinics |
| Results posted | Yes |
2. Clinical Question
The registry frames the central question as whether a personalized self-care support program is acceptable to patients with diabetic foot ulcer and wound care nurses, and feasible to deliver in primary care. It also describes an intended pre-intervention to post-intervention comparison to examine support for self-care management. The posted record does not report numerical results for that comparison, nor does it report a numerical measure of acceptability.
Population
Eligible and willing primary care patients living with diabetic foot ulcer. The registry lists enrollment as 29. It also reports that 3 participants withdrew because their healthcare institutions changed, for example, from primary care to secondary or tertiary settings.
Intervention
A personalized self-care support program described as supporting self-care and Healing through Empowerment and Active Listening (HEALing). Participants were to receive three 30-minute face-to-face sessions, once every 2 weeks, within 6 weeks of enrollment and after routine wound care dressing.
Comparator
There is no separate control group. The study is recorded as a single-group study, so the proposed pre-intervention and post-intervention observations are not a randomized comparison with usual care or another intervention.
Primary question
How many patients were recruited and retained through the end of the study period? The primary measure is described as a participant count, with assessment 4 weeks post-intervention from baseline. Numerical recruitment and retention results are not reported in the registry record.
This distinction matters: the stated primary question concerns whether the study can recruit and retain participants, while the broader rationale also concerns acceptability, feasibility of delivery, and potential changes in self-care-related outcomes. The record does not provide enough numerical outcome information to assess those changes.
3. Trial Design
This completed study is registered as a single-group behavioral intervention study. Its title concerns a personalized self-care support program for primary care patients with diabetic foot ulcer, and the official title emphasizes feasibility and acceptability. The listed sponsor is National Healthcare Group Polyclinics. The record lists the phase as NA, allocation as NA, and masking as none. It does not describe a randomized allocation process or a parallel control arm.
The intervention is described as three face-to-face sessions, each lasting 30 minutes, delivered once every 2 weeks within 6 weeks of enrollment. The brief description places sessions after routine wound care dressing. Eligible and willing participants were invited to take part. The registry lists enrollment as 29 and the study status as completed. The recorded start date is 2024-08-13, and the primary completion date is 2025-01-11.
The intended primary feasibility measure is the number of patients recruited and the number retained at the end of the study period. Its timeframe is stated as 4 weeks post-intervention from baseline. The record also describes an intended comparison of measurements before and after the intervention. However, the posted results contain no analysis entries, and numerical pre-intervention or post-intervention estimates are not reported in the registry record.
A single-group design can describe participation and changes observed over time among participants, but it does not isolate the intervention from other explanations for change. Without a concurrent control group, differences between pre-intervention and post-intervention measurements cannot by themselves establish that the program caused those differences. The registry record does not report a protocol, a sample-size justification, or additional design details that would clarify how feasibility or acceptability was defined beyond the listed outcome descriptions.
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 | Single Arm Study |
|---|---|
| STARTED | 29 |
| COMPLETED | 26 |
| NOT COMPLETED | 3 |
Analysis population for the primary outcome, as defined in the registry: 3 patients withdrew from the study due to changes to their healthcare institutions (e.g., from primary care settings to secondary/tertiary settings).
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.
Population: Patients with diabetic foot ulcers receiving wound care at the participating clinics
| Characteristic | Unit | Single Arm Study |
|---|---|---|
| Participants analysed | 26 | |
| Age, Continuous | years | 64 (SD 10) |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 18 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 26 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: Singapore | participants | 26 |
6. Primary Endpoint
The registry lists the primary outcome as Feasibility of Recruiting and Retaining, measured over 4 weeks post-intervention from baseline..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Feasibility of Recruiting and Retaining.” It measures participant counts: the number of patients recruited and the number retained at the end of the study period. The registry gives a timeframe of 4 weeks post-intervention from baseline and describes documenting recruitment and retention. It also reports that 3 participants withdrew because their healthcare institutions changed, such as a move from primary care to secondary or tertiary care. A final retained count is not reported in the registry record, so the number who completed follow-up cannot be established from the posted results.
Recruitment and retention counts are used in feasibility research to describe whether participants can be enrolled and remain involved through the planned study period. They address operational questions about conducting a study, rather than directly measuring whether an intervention changes health outcomes. Counts can help describe the flow of participation, but a count alone does not explain why people did or did not enroll, how representative participants were, or whether the program was acceptable to patients and staff. Those additional interpretations require corresponding definitions and results, which are not reported in the registry record.
The outcome description does not provide a numerical target for recruitment or retention, a threshold for judging feasibility, or a reported final retention value. Therefore, the record establishes what the investigators intended to count, but it does not provide a complete numerical assessment of whether recruitment and retention met a predefined criterion.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a completed study with enrollment of 29 and reports that 3 participants withdrew because of changes to their healthcare institutions. These registry entries describe enrollment and a reason for withdrawal, but they do not establish the final number retained at the primary endpoint. The primary outcome description says that recruitment and retention would be documented; the corresponding numerical results are not reported in the registry record. No retention proportion or other derived quantity can therefore be interpreted from the posted information.
The record describes the intended program and its delivery schedule, and it lists multiple secondary outcomes related to self-care behavior, confidence, illness beliefs, autonomy support, diabetes distress, recognition of wound deterioration, quality of life, and HbA1c. It does not report numerical results for these outcomes. The posted results also contain no analysis entries. Consequently, the record does not show whether measurements changed from before to after the intervention, how variable those measurements were, or how precisely any estimated change was measured.
The study's single-group design is important to interpretation. A pre-intervention and post-intervention comparison can describe observed change among participants, if those measurements and analyses are reported. Without a concurrent comparator, however, such a change cannot distinguish an intervention effect from other influences, including changes over time or changes in care circumstances. The registry does not report an analysis plan that would address these limitations, and no adjusted or unadjusted effect estimate is posted.
The withdrawal explanation gives context for participant follow-up: some participants changed healthcare institutions. It does not establish whether all withdrawals had the same consequences for outcome availability, whether any other observations were missing, or how missing measurements were handled. Those details are not reported in the registry record.
The registry also records zero for the listed serious and other adverse-event counts in the single-arm study. This is a description of the posted event fields, not evidence that every possible event was actively assessed or that no event could have occurred. The record does not provide further detail about event collection, ascertainment, or the period covered.
Overall, the posted information describes the study's feasibility aims, intervention schedule, enrollment, and reported withdrawals. It does not provide the outcome estimates needed to assess recruitment and retention numerically, acceptability, or pre-intervention to post-intervention changes. These gaps limit statistical interpretation; they do not establish either a favorable or unfavorable result.
9. Statistical Methods Explained
The statistical information in the registry is limited. It identifies the primary endpoint as counts of participants recruited and retained, lists secondary outcomes, and records no analysis entries. A detailed statistical analysis plan is not reported in the registry record. The explanations below describe general statistical concepts and should not be read as a claim about methods actually used in this study.
What does a participant count describe?
A count reports how many people meet a specified definition, such as being recruited or retained through follow-up. For a feasibility question, the definition and time point matter: recruitment concerns entry into the study, while retention concerns continued participation to the stated endpoint. Counts are straightforward to interpret when the study also reports the intended recruitment target, the number eligible or invited, and the number with outcome information. Those additional details are not reported in the registry record. Although enrollment is listed as 29, the final retained count and a numerical recruitment result are not reported.
A count is not the same as a measure of treatment effect. It does not quantify a change in wound status or self-care, and it does not establish that a program caused an outcome. If a study uses a prespecified feasibility threshold, the observed recruitment or retention can be judged against that threshold. The registry record does not report such a threshold.
What can a pre-intervention and post-intervention comparison show?
In general, a before-and-after analysis describes how measurements differ across two time points in the same group. The interpretation depends on the outcome scale, the way measurements are paired, the amount of missing data, and the statistical method. A confidence interval, in general, expresses uncertainty around an estimated quantity: narrower intervals indicate greater precision under the assumptions of the method, while wider intervals indicate less precision. No numerical pre-intervention to post-intervention estimates or confidence intervals are reported in the registry record, so the magnitude and precision of any change cannot be evaluated.
A single-group comparison has no concurrent control group to represent what might have happened over the same period without the program. General sources of change over time can therefore remain entangled with any observed change. This is a design limitation, not a conclusion about the direction or size of an outcome. The registry record does not report a method for addressing this limitation.
What do the secondary outcomes add?
The listed secondary outcomes cover several domains: adherence to foot self-care behavior, foot care confidence or self-efficacy, illness belief, perceptions of autonomy support, diabetes distress, knowledge of recognizing wound deterioration, quality of life, and HbA1c. These are distinct outcomes and may use different measurement scales. In general, each requires a clearly defined measure, time point, analysis population, and summary appropriate to its scale. The record lists 10 outcome measures overall but does not report numerical results or analysis entries for them. The outcome-specific instruments, scoring rules, and handling of repeated measurements are not reported in the registry record.
When multiple outcomes are examined, the chance of at least one apparently notable result can increase if each is tested separately without a plan for interpreting multiplicity. General approaches include identifying a primary outcome in advance, prespecifying a hierarchy, or adjusting inference for multiple tests. The registry record identifies a primary endpoint and lists secondary outcomes, but it does not report a multiplicity strategy or the results of tests. No claim about statistical significance across these outcomes is possible from the posted information.
How should planning illustrations be read?
The registry describes a sample-size planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; it says the effect to detect is a stated fraction of the observed effect. This is described as a planning illustration, not as the trial's own design. The actual study is recorded as single-group, with allocation listed as NA, so a two-arm planning framework should not be mistaken for the study design or for evidence that a two-arm comparison occurred. Numerical illustration results are not reported in the registry record.
In general, sample-size calculations are conditional on assumptions about the outcome, variability, effect size, design, and analysis. A planning calculation is not an observed result, and it is not observed power. The registry does not report a trial-specific sample-size justification or the assumptions used to choose enrollment. No conclusion about whether the study was adequately sized for its feasibility objectives can be drawn from the listed illustration assumptions alone.
What does the record say about analysis populations?
In general, an analysis population specifies which participants contribute to each outcome analysis and how departures from the planned follow-up are handled. The registry record notes 3 withdrawals related to healthcare institution changes, but it does not report the number contributing data to each outcome or how missing measurements were treated. It also does not identify an analysis population or state whether participants were analyzed according to any particular inclusion rule. These details are necessary to understand how an estimate would relate to the enrolled group.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Single Arm | 29 | 26 | 89.7% | 72.6% to 97.8% | 73.6% to 96.4% | 73.5% to 96.2% |
R code and output
arm <- c("Single Arm")
n <- c(29)
events <- c(26)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Single Arm 29 26 89.7 72.6 97.8 73.6 96.4 73.5 96.211. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary recruitment-and-retention endpoint and multiple secondary outcomes, including self-care behavior, confidence, illness beliefs, perceived autonomy support, diabetes distress, knowledge about recognizing wound deterioration, quality of life, and HbA1c. It lists 10 outcome measures overall. The posted results contain no analysis entries, and numerical results for the listed outcomes are not reported in the registry record. The statistical plan for handling multiple outcomes is also not reported in the registry record.
As a general statistical matter, examining multiple outcomes raises questions about which results are confirmatory and how uncertainty is interpreted across them. A prespecified hierarchy or other multiplicity strategy can clarify how secondary findings should be read. Without a reported strategy and outcome estimates, there is no basis to characterize statistical significance or to distinguish planned analyses from exploratory ones in this study.
The record reports that 3 participants withdrew because of changes to their healthcare institutions. It does not report the final retained count, the amount of missing outcome data, or the reasons for any missing measurements beyond the stated withdrawals. It also does not say whether analyses used complete cases, another analysis population, or a method for handling missing data. In general, missing-data methods rely on assumptions about why observations are missing; different assumptions can affect the interpretation of an estimate. No such method or assumption is reported in the registry record.
The registry record does not identify an analysis population for the primary or secondary outcomes. It is therefore unclear which participants would contribute to any reported outcome estimate. This is not evidence that a particular analysis approach was or was not used; the relevant information is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record describes a feasibility and acceptability study of a personalized self-care support program for primary care patients with diabetic foot ulcer. It establishes that the study was completed, lists enrollment as 29, specifies the planned session schedule, and reports 3 withdrawals associated with changes in healthcare institutions. These details provide context about the study's conduct and participation.
The posted information does not establish a final retention count, a numerical measure of acceptability, or a numerical assessment of feasibility. It also does not report results for the listed secondary outcomes or the intended pre-intervention to post-intervention comparison. Thus, the record does not show how self-care measures, confidence, illness beliefs, distress, quality of life, or HbA1c changed, or how precisely any change was estimated. Absence of these results from the registry record should not be interpreted as evidence of no change.
The single-group design also defines what an observed before-and-after difference could mean. In general, a difference over time in one group is descriptive and cannot on its own separate the intervention from other changes during the same period. The record does not include a randomized control comparison, and it does not report an alternative method for identifying a causal effect. Accordingly, the listed study design cannot support a direct comparison with another treatment or usual care.
The record's adverse-event fields list zero counts for the single-arm study. Those entries describe the registry fields; without further information on collection and assessment, they do not establish the completeness of safety monitoring or rule out events outside the recorded scope.
For readers, the central distinction is between the study's aims and its posted findings. The aims concern feasibility, acceptability, and support for self-care. The registry documents planned measures and some participation information, but numerical outcome analyses are not reported. The posted record therefore supports a description of the study design and reporting gaps, not a conclusion about the program's effects.
13. Why This Trial Matters Statistically
Feasibility studies address practical questions that precede or accompany evaluation of outcomes: whether eligible participants can be recruited, whether they remain in follow-up, and whether an intervention can be delivered as intended. This study's stated focus on recruitment, retention, acceptability, and delivery is therefore distinct from a conventional comparison intended to estimate a treatment effect. Keeping those aims separate helps readers avoid treating a feasibility endpoint as evidence of clinical benefit.
The trial record also illustrates why design and analysis need to be read together. The intervention is delivered to a single group, while the brief description mentions a pre-intervention to post-intervention comparison. Such a comparison can describe change if results are available, but without a control group it cannot establish what would have happened over the same period without the program. Statistical interpretation depends not only on a test or estimate, but also on the design that generated the data.
Clear reporting of participant flow is especially relevant to the stated endpoint. The record reports enrollment and a reason for 3 withdrawals, but does not report the final retained count. Without that endpoint result, readers cannot assess retention numerically or relate follow-up completeness to the planned study period. Likewise, outcome estimates and missing-data information would be needed to understand the listed secondary measures.
The registry lists a range of outcomes spanning behavior, beliefs, confidence, distress, knowledge, quality of life, and HbA1c. Such breadth makes prespecification and transparent reporting important: readers need to know which analyses were planned and how to interpret multiple outcomes. Those analysis details and results are not reported in the registry record. The statistical significance, precision, and practical meaning of changes therefore cannot be assessed from the posted information.
The study remains statistically informative as an example of the questions a feasibility design is intended to address and of the limits imposed by incomplete outcome reporting. Its record documents the design and intervention schedule, while leaving the numerical answers to its central outcome questions unavailable.
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.
A key limitation is that numerical results for the primary endpoint are not reported in the registry record. Although recruitment and retention are specified as the primary measure, the record does not provide the final retained count or a recruitment result suitable for assessing the endpoint. It reports 3 withdrawals associated with changes in healthcare institutions, but does not describe the full participant flow or provide outcome-specific follow-up counts.
The record also does not provide numerical results for acceptability or for the listed secondary outcomes. It describes an intended pre-intervention to post-intervention comparison, but no estimates, measures of variability, confidence intervals, or analysis entries are posted. This prevents assessment of the direction, magnitude, and precision of any observed changes.
The single-group design limits causal interpretation even if pre-intervention and post-intervention results were available. There is no concurrent control arm in the registry record, and no causal analysis approach is reported. The study is not a like-for-like randomized comparison.
Additional details that would aid assessment are not reported in the registry record: a trial-specific sample-size justification, recruitment or retention thresholds, operational definitions and instruments for the outcomes, a statistical analysis plan, the analysis populations, and methods for handling missing observations. The record's general planning-illustration assumptions do not substitute for a study-specific design justification. The adverse-event fields also lack further detail about ascertainment and coverage. These limitations concern what can be interpreted from the registry entry and do not imply that unreported procedures were not conducted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Personalized Self-care Support Program for Primary Care Patients With Diabetic Foot Ulcer — NCT06540170.
- Registry record last updated 2025-08-26; status last verified 2025-08.
- Results first posted 2025-08-26.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
This completed, single-group behavioral study evaluates a personalized self-care support program for primary care patients with diabetic foot ulcer. The listed sponsor is National Healthcare Group Polyclinics. The registry reports enrollment of 29, a start date of 2024-08-13, and a primary completion date of 2025-01-11.
Participants were to receive three 30-minute face-to-face sessions once every 2 weeks within 6 weeks of enrollment, after routine wound care dressing. The primary endpoint concerns counts of participants recruited and retained, with a stated timeframe of 4 weeks post-intervention from baseline. The registry reports 3 withdrawals related to changes in healthcare institutions but does not report the final retained count or numerical outcome analyses.
Secondary outcomes cover several self-care and health-related domains, including HbA1c. The posted results contain no analysis entries. The registry therefore describes the study aims, intervention, and some participation information, but numerical findings for feasibility, acceptability, and pre-intervention to post-intervention outcomes are not reported in the registry record.