Immunonutrition for Diabetic Foot Ulcers: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Immunonutrition for Diabetic Foot Ulcers (NCT05281562), a randomized phase 2, phase 3 study. The primary outcome is Effect of Supplemental Immunonutrition on Wound Healing in Patients With Diabetic Foot Ulcers as Assessed by the Pressure Ulcer Scale for Healing (PUSH) Tool 3.0..

2. Clinical Question

3. Trial Design

The study was registered as a randomized, parallel-group pilot study and is listed under phase 2 and phase 3. It was unmasked, meaning the registry does not describe blinding of participants or study personnel to group assignment. The planned comparison was supplemental immunonutrition plus wound care versus standard-of-care wound treatment determined by a treating physician. The registry does not report a more detailed allocation procedure or explain how the randomization sequence was generated or concealed.

The supplement was intended as a daily oral course lasting six weeks. It comprised Omega-3 fatty acids, L-Arginine, and Vitamin C at the amounts specified in the intervention description. The primary assessment was planned at consent and six weeks, with change in PUSH Tool 3.0 score as the outcome. The record also describes patient satisfaction and longer-term outcomes related to ulcer recurrence, infection, surgical intervention, and amputation as secondary topics. Their assessment schedules and analytic details are not reported in the registry record.

The study started on 2023-02-08 and had a primary completion date of 2023-03-20. Its status is terminated. The enrollment record reports one subject, assigned to the standard-of-care group; that subject was withdrawn before six weeks. No subjects enrolled to the immunonutrition group. The registry does not report why the study was terminated or why the subject was withdrawn. These registry entries define the scope of interpretation: the record describes the intended design, but does not contain a completed randomized comparison of wound healing.

A pilot study can be intended to assess feasibility or inform later research, but the specific objectives beyond the listed outcomes are not reported in the registry record. Nor are recruitment targets, a sample-size justification, or a detailed protocol available in the record. The word “pilot” alone does not establish what feasibility criteria were planned or whether they were met.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Only one study subject enrolled before study was closed and participant was withdrawn before 6 weeks. The study subject was enrolled to the no supplement arm; no subjects enrolled to treatment arm.

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: Only one study subject enrolled and study was closed one month later. The study subject was enrolled to the no supplement arm; no subjects enrolled to treatment arm.

6. Primary Endpoint

The registry lists the primary outcome as Effect of Supplemental Immunonutrition on Wound Healing in Patients With Diabetic Foot Ulcers as Assessed by the Pressure Ulcer Scale for Healing (PUSH) Tool 3.0., measured over 6 weeks.

The primary endpoint was intended to capture change in ulcer severity from consent to six weeks using the Pressure Ulcer Scale for Healing, or PUSH Tool 3.0. The tool scores three ulcer features: size, exudate amount, and tissue type. Those category scores are combined into a final score ranging from 0-17. Higher values indicate a more severe ulcer. The registry describes recording scores at consent and six weeks for both groups, then calculating change between those assessments.

A structured score can make wound status more consistent to describe than an unstructured impression alone. Combining features of the ulcer also reflects that healing is not represented by a single characteristic. As a general statistical point, a change score compares a participant’s follow-up measurement with that participant’s starting measurement. This can describe within-person change, but a treatment comparison requires outcome information from the groups being compared. Without follow-up scores and an enrolled supplementation group, the planned contrast cannot be estimated from the registry record.

The record does not report unit-level scores, group summaries, a treatment-effect estimate, or a confidence interval for this endpoint. It therefore provides no estimate of the size or precision of a difference in wound-healing change. The six-week endpoint should be understood as the planned outcome, not as a completed result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What comparison was planned? The design describes randomized assignment to a parallel-group comparison: a supplementation group and a standard-of-care group. In a parallel design, each participant is assigned to one group and outcomes are compared across groups. Randomization can reduce the influence of known and unknown baseline differences on the comparison, especially when there are enough participants and the assigned groups are represented. It does not guarantee balance in every study, and it cannot compensate for the absence of outcome data.

The registry describes no masking. In general, masking means keeping treatment assignment unknown to specified people involved in a study. When people know the assigned treatment, expectations or decisions about assessment and care can potentially influence some outcomes. The record does not report whether any safeguards against such influence were planned, or whether outcome scoring was performed by someone unaware of assignment.

What does the endpoint measure? The primary outcome uses the PUSH Tool 3.0, combining ulcer size, exudate amount, and tissue type into an overall severity score. The registry says higher scores indicate more severe ulcers. The planned outcome is change between consent and six weeks. A change score can summarize how an individual’s measured status shifts over time. To estimate a comparative effect, an analysis must then compare the change between the randomized groups or use another prespecified approach that accounts for baseline status and follow-up.

In general, an outcome measure is useful only if the relevant observations are collected in a way that supports the planned interpretation. The record does not give the enrolled subject’s PUSH scores at consent or at six weeks, and says the subject was withdrawn before the six-week visit. It also reports no enrollment in the supplementation arm. The registry therefore does not contain the information needed to calculate or compare the planned endpoint.

What can a confidence interval communicate? General statistical explanation: a confidence interval expresses uncertainty around an estimated quantity under the model and assumptions used to calculate it. A narrow interval typically indicates greater precision than a wide interval, while an interval spanning values in different directions may leave the direction of an effect uncertain. Such an interval requires an estimate and usable data. Neither is reported for the primary treatment comparison, so precision cannot be assessed from a primary endpoint confidence interval.

What does a p-value address? General statistical explanation: a p-value measures how unusual data at least as incompatible with a specified null hypothesis would be, if that hypothesis and the statistical model were correct. It is not the probability that a treatment works, and it does not measure the size or clinical importance of an effect. The registry reports zero analyses and no primary comparison, so there is no reported p-value to interpret. A p-value would not overcome the underlying absence of a completed comparison.

Why do analysis choices matter? A statistical analysis plan normally specifies the outcome contrast, model, treatment of baseline measurements, missing observations, and population used for analysis. These choices should be set out clearly because different defensible approaches can answer different questions. The detailed statistical plan is not reported in the registry record. No model, adjustment strategy, or analysis population is described, so none should be attributed to this study.

In general, analysis by assigned group estimates the effect of assignment under the conditions of the study, while analyses based on treatment received or completion can answer different questions and may be more vulnerable to selection bias. This distinction matters when participants do not complete follow-up. The registry does not report an analysis population or an analysis of the withdrawn subject. It is therefore not possible to determine how the study would have handled that subject in a completed analysis.

What is over-dispersion? General statistical explanation: over-dispersion occurs when observed variability is greater than a statistical model expects. It can make standard errors too small if the model fails to account for the extra variation. This issue can arise in some kinds of count or clustered data, but the record does not report an analysis for which over-dispersion was assessed. It is not possible to say that it affected this trial’s results.

Any sample-size calculation is a planning illustration, not observed power. Power is a property of a planned design under specified assumptions; it is not a measure of whether a completed study found an effect. In this record, the primary comparison was not reported as analyzed, so a planning calculation cannot be interpreted as evidence about the result or as a substitute for one. The registry does not report the trial’s own sample-size justification or detailed statistical plan.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary wound-healing outcome and describes secondary topics concerning patient satisfaction and longer-term ulcer recurrence, infection, surgical intervention, and amputation. It also records four outcome measures. The detailed definitions, analysis schedules, and hierarchy among these outcomes are not reported in the registry record. No analyses are reported, so there are no multiple outcome findings from which to assess selective emphasis or consistency.

Multiplicity refers, in general, to the increased chance of a misleading positive finding when many hypotheses or outcomes are tested. Statistical plans may address this by defining a primary outcome, limiting confirmatory tests, or adjusting inference for multiple comparisons. The registry does not report whether any multiplicity strategy was planned. Since it reports no outcome analyses, the issue cannot be evaluated from observed test results in this study.

The enrolled subject was withdrawn before the planned six-week primary assessment. The registry does not report the reason for withdrawal, the subject’s recorded scores, or how missing measurements were handled analytically. It also does not report an analysis population or a missing-data method. In general, missing outcome data can affect a treatment comparison when the chance of missingness is related to participant characteristics, treatment, or outcome. The degree and direction of any such effect cannot be assessed from the information recorded.

The record does not report an intention-to-treat analysis, a per-protocol analysis, imputation, or sensitivity analysis. These are not interchangeable approaches: they can target different questions and rely on different assumptions. Naming an approach without evidence that it was specified or used would be unwarranted. The primary result is therefore best characterized as not reported, rather than as a null finding or a finding of no difference.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists the standard-of-care group as having one subject at risk for serious adverse events and one at risk for other adverse events. It records zero serious adverse events, zero other adverse events, and zero deaths in that group. For the immunonutrition group, the registry lists zero subjects at risk and zero events. No serious adverse-event terms are listed.

These counts describe the safety information entered in the registry. They do not establish that supplementation had no adverse events: no subjects enrolled in that group, so there was no treatment-arm exposure recorded for this comparison. The zero event counts in standard care likewise should not be read as proof that the group had no possible risk. They report the events recorded during the available observation, not a comprehensive estimate of event probability.

In general, safety counts are more informative when the number of people exposed, duration of observation, event definitions, and completeness of reporting are clear. The record provides only limited exposure and follow-up information, and the enrolled subject was withdrawn before six weeks. It does not report a detailed adverse-event collection schedule or additional safety analysis. The figures therefore have very limited ability to characterize comparative safety.

12. What the Result Does, and Does Not, Mean

The registry record establishes that a randomized pilot study was planned to compare six weeks of daily oral immunonutrition plus wound care with standard-of-care wound treatment for diabetic foot ulcers. It identifies a wound-healing outcome based on the PUSH Tool 3.0 and describes other intended outcomes. It also records that the study was terminated after one subject enrolled in the standard-of-care group and was withdrawn before the six-week assessment. No subjects enrolled in the supplementation group.

What the record does not establish is whether supplementation changed ulcer severity, whether the groups differed, or how large or precise any difference might have been. There is no reported primary endpoint estimate, comparative analysis, or confidence interval. Accordingly, the record cannot support a conclusion that the supplement improved healing, worsened healing, or had the same effect as standard care. The lack of an estimate is not evidence of no effect.

The record also does not establish comparative safety. No subjects enrolled in the immunonutrition arm, and the safety counts in the standard-of-care arm describe only the recorded observations there. They cannot show what adverse events would occur with supplementation or how its safety compares with standard care.

More broadly, a small pilot study may be intended to inform the design or feasibility of later research, but the registry does not report specific feasibility criteria or whether they were met. The reason for termination is also not reported. Thus, it is not possible to infer whether recruitment, logistics, safety, or another factor drove the study’s closure.

The appropriate statistical reading is narrow: the registry describes an intended clinical question and records incomplete enrollment and follow-up, but contains no completed treatment-effect comparison. It should not be treated as either supportive or refuting evidence about the efficacy of immunonutrition for diabetic foot ulcers.

13. Why This Trial Matters Statistically

This study matters statistically because it illustrates the difference between a design and a result. Randomization, a defined comparator, a stated primary outcome, and planned follow-up describe how a treatment effect could be studied. They do not themselves provide evidence about that effect. To answer the question, the record would need outcome information from the assigned groups and an analysis that compares them.

Here, enrollment did not produce an observed supplementation group, and the only enrolled subject was withdrawn before the planned primary assessment. The registry reports no analyses. This means the central limitation is not an imprecise estimate or a nonsignificant test; it is the absence of a reported estimate and test. Distinguishing these situations prevents an uncompleted comparison from being mistaken for evidence of no difference.

The study also highlights why follow-up and missing-data reporting matter. An outcome can be clearly defined, but if the planned measurements are not available, the intended comparison cannot be made. Reporting withdrawal reasons, measured values, analysis populations, and planned handling of missing data can help readers understand what a study did and did not establish. Those details are not reported in the registry record.

Finally, safety counts need their exposure context. Zero recorded events in a group with a subject at risk and no subjects at risk in the other group do not provide a balanced safety comparison. Clear reporting of exposure, follow-up, event definitions, and analysis is essential for interpreting even simple event counts. This record is a useful example of why statistical conclusions must follow the actual observed information, not the study’s intended design.

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 principal limitation is the absence of a completed primary outcome comparison. The registry reports one enrolled subject, assigned to standard care and withdrawn before six weeks, with no subjects enrolled to the immunonutrition arm. It reports no analyses or primary endpoint values. As a result, there is no treatment-effect estimate and no basis for assessing its precision.

The reason for termination and the reason for withdrawal are not reported in the registry record. These omissions prevent assessment of whether the limited enrollment and follow-up were related to recruitment, conduct, participant circumstances, or another factor. The record also does not provide a detailed account of treatment adherence, actual supplement exposure, or completed visit data.

The planned primary measure and intervention are described, but several important design and analysis details are not reported. These include the randomization procedure, allocation concealment, outcome-assessor masking, the detailed statistical plan, the sample-size justification, the analysis population, and the handling of missing observations. The standard-of-care group is described as receiving treatment determined by a treating physician, without a more detailed protocol in the record.

The safety information has similarly limited scope. There were no subjects at risk in the supplementation group, and the available event counts cannot characterize comparative safety. The registry does not report detailed safety definitions, collection procedures, or duration of adverse-event surveillance.

These limitations mean the record cannot establish efficacy, comparative safety, feasibility, or the reason the study ended. They should not be converted into a claim that the supplement failed, that it was safe, or that the study encountered any particular operational problem.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Immunonutrition for Diabetic Foot Ulcers — NCT05281562.
• Registry record last updated 2024-12-27; status last verified 2024-12.
• Results first posted 2024-12-27.
• 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.

18. Record Summary

NCT05281562, “Immunonutrition for Diabetic Foot Ulcers,” was a randomized, unmasked, parallel-group pilot study sponsored by Prisma Health-Midlands. It was listed under phase 2 and phase 3 and is recorded as terminated. The study started on 2023-02-08, with primary completion dated 2023-03-20.

The planned intervention was six weeks of daily oral Omega-3 fatty acids, L-Arginine, and Vitamin C, compared with standard-of-care wound treatment determined by a treating physician. The primary outcome was change in ulcer severity from consent to six weeks using the PUSH Tool 3.0. The registry also describes patient satisfaction and longer-term ulcer outcomes.

One subject enrolled in the standard-of-care group and was withdrawn before six weeks; no subjects enrolled in the immunonutrition group. The registry reports zero analyses and no primary treatment-effect estimate. The reason for termination is not reported in the registry record.