Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers (NCT06403605), a randomized na study. The primary outcome is Complete Wound Healing.

2. Clinical Question

The central statistical question is whether the observed difference in complete wound closure between the dressing strategies is estimated precisely enough to distinguish a meaningful difference from sampling variation. Random assignment supports a comparative analysis, but it does not by itself establish what the results were or how certain they are. Those judgments require the outcome counts, a defined analysis, and measures of uncertainty, none of which are reported as a single primary comparison in the registry record.

The question concerns the dressing strategy within a context of standard wound care, not the matrix or dressing in isolation. Both descriptions include offloading and an outer dressing. The trial therefore compares care approaches as specified in the registry, rather than an intervention against no wound care. Its stated population is people with diabetic foot ulcers; more detailed eligibility criteria are not reported in the registry record.

The registry names additional outcomes concerning percentage area reduction, time to heal, quality of life, and pain. These broaden the clinical questions beyond complete closure, but the reported information does not establish how those outcomes were analyzed or whether they support a consistent comparative conclusion.

3. Trial Design

This was a prospective, multicenter, randomized controlled trial with a parallel-group design. Participants were assigned to a primary dressing strategy involving Mirragen Advanced Wound Matrix or to a strategy involving Fibracol. Both arms included standard of care and descriptions of offloading and an additional moisture-retention dressing. The registry reports enrollment of 148 participants.

The study is listed as completed. Its recorded start date is 2022-09-13, and its primary completion date is 2025-01-17. The registry identifies ETS Wound Care, LLC as the sponsor. The study description says it was designed to collect patient outcome data on two commercially available treatments for diabetic foot wounds.

Masking is listed as none. This means the registry does not describe the trial as masked; whether outcome assessors were separately masked is not reported in the registry record. Details of the randomization sequence, allocation concealment, stratification, or implementation are also not reported in the registry record. The allocation is identified as randomized, but that label alone does not disclose those procedural details.

The primary outcome is complete wound healing, described as the proportion of subjects achieving complete wound closure, with a 12-week timeframe. The registry says that both modified intent-to-treat and per-protocol analysis populations are represented. It does not report the population-specific outcome values, the way participants were assigned to those populations, or which population was designated as primary for the main comparison.

Secondary outcomes listed are percentage area reduction, time to heal, changes in quality of life, and change in pain level. The registry record does not report a detailed statistical analysis plan, including the planned model, covariate adjustment, or procedures for handling repeated assessments. It also does not report a sample-size justification or interim-analysis plan. Those details should not be inferred from the randomized design or from the trial’s completion status.

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.

Before assignment: 245 subjects were assessed for eligibility to participate in the study.

Randomization and Initial Treatment

Follow-up

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.

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: Both modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.

6. Primary Endpoint

The registry lists the primary outcome as Complete Wound Healing, measured over 12 weeks.

Complete wound healing is defined in the registry as the proportion of subjects achieving complete wound closure. In practical terms, this is a binary outcome for each participant at the stated assessment: the wound either meets the study’s definition of complete closure or it does not. The registry describes the measure in participants and gives a 12-week timeframe.

A closure endpoint is useful because it expresses an outcome in a form that can be compared between randomized groups. The proportion achieving closure conveys how frequently the specified outcome occurred within each group, while a between-group contrast addresses the comparative question. General statistical interpretation should consider both the estimated contrast and its uncertainty; an observed difference alone does not show how precisely the effect is estimated.

The record does not specify the operational criteria for complete closure, how confirmation was determined, or how healing status was handled if an assessment was unavailable. Those details matter because definitions and assessment procedures can affect classification. The registry also says that both modified intent-to-treat and per-protocol populations are represented, so the reported endpoint could be summarized for more than one analysis population. The population-specific counts and estimates are not reported in the registry record.

Although the endpoint is defined and timed, the posted outcome information is not reduced to a single comparison. Therefore, its stated definition should not be mistaken for a reported estimate of the difference between dressing strategies.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical concepts can clarify what a complete report would allow readers to evaluate, but the registry record does not report a detailed analysis plan. The explanations below are general and should not be read as claims about analyses performed in this trial.

How does a binary endpoint work?

A binary endpoint classifies each participant into one of two outcome states. For complete wound healing, the registry’s stated outcome is whether complete closure was achieved within the 12-week timeframe. Group-specific proportions would describe the share of participants in each analysis group classified as having achieved closure. A comparative estimate could then express the contrast between those proportions. The record does not report a single set of group-specific primary outcome counts or a comparative estimate, so the contrast cannot be interpreted from the posted information.

Binary outcomes can be analyzed using methods designed for proportions, including approaches based on differences in proportions or regression models. The selected method affects the form of the estimate and, in some settings, the assumptions used for uncertainty estimates. The statistical method used for the primary outcome is not reported in the registry record. It should not be inferred from the fact that the outcome is binary.

Why consider uncertainty as well as the estimate?

General statistical reasoning separates the estimated effect from its precision. A confidence interval expresses uncertainty around an estimate under the chosen model and assumptions. Its width is influenced by the amount of outcome information and its distribution across groups. A confidence interval is not a guarantee that the true effect lies within its limits, nor does it establish clinical importance by itself. The registry record does not report a confidence interval for a single primary comparison.

A p-value, when calculated under a specified hypothesis test, describes how unusual data at least as incompatible with that hypothesis would be under the test’s assumptions. It does not measure the probability that a treatment effect is real, and it does not quantify the size or clinical relevance of an effect. The registry record does not report a primary-comparison p-value. The significance level of 0.05 appears only as an assumption in the described planning illustration, not as a reported trial result or a confirmed analysis threshold.

What does randomization contribute?

In general, random allocation is intended to make treatment groups comparable with respect to both observed and unobserved characteristics at the point of assignment, on average across repeated assignments. It supports a causal comparison when the trial is conducted and analyzed appropriately. Randomization does not ensure identical groups in a particular trial, eliminate missing data, or prevent bias arising after assignment. Details such as sequence generation and allocation concealment are not reported in the registry record.

Masking can reduce the influence of expectations on care, assessment, or reporting. The registry lists masking as none. That is relevant context for an outcome involving assessment of wound closure, but the record does not say whether outcome assessors had separate masking arrangements. It would be inappropriate to assume either that assessors were masked or that they were not based on information not given.

Why might analysis populations matter?

The record represents both a modified intent-to-treat population and a per-protocol population. In general, an intent-to-treat approach aims to preserve comparison according to randomized assignment, while modified definitions may exclude or otherwise handle participants according to prespecified rules. A per-protocol analysis commonly focuses on participants who meet specified adherence or eligibility criteria. These approaches can differ in their susceptibility to bias and in the question they answer. The exact definitions, exclusions, and primary analysis designation are not reported in the registry record, so the labels alone do not establish how the analyses were conducted.

Missing outcome data can affect binary proportions if participants with unknown healing status are excluded, counted as not healed, or handled through a model or imputation procedure. Different choices rely on different assumptions. A sound interpretation needs to know the extent and pattern of missingness and the analysis used to address it. Those details are not reported in the registry record. No missing-data method should be assumed.

What do the planning assumptions mean?

The registry describes a planning illustration based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. Such calculations are hypothetical planning exercises: they describe a sample size under stated assumptions and are not observed power, proof of effect, or a summary of the trial’s results. The registry record does not report the numerical planning outputs or a sample-size justification from the trial’s own design. The planning assumptions therefore should not be treated as evidence that the trial was adequately powered for its primary outcome.

General power calculations depend on the assumed effect, variability or event rate, significance level, allocation, and analysis method. If an assumed effect is based on an observed estimate, that estimate itself is uncertain. Planning for a fraction of an observed effect illustrates sensitivity to assumptions; it does not repair the lack of a reported primary comparison. The record does not provide enough detail to evaluate the assumptions or reproduce the illustration.

How should multiple outcomes be considered?

When a study evaluates multiple outcomes, time points, or analysis populations, the chance of at least one apparently notable result can increase if each is tested separately without an adjustment or an interpretive plan. General strategies include prespecifying a primary outcome, controlling an error rate, or treating secondary analyses as exploratory. The registry lists a primary endpoint and several secondary outcomes, but the multiplicity strategy and testing hierarchy are not reported. The outcome information is also not reduced to a single primary comparison, limiting interpretation across the listed measures.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies complete wound healing at 12 weeks as the primary outcome and lists secondary outcomes concerning percentage area reduction, time to heal, quality of life, and pain. It also states that both modified intent-to-treat and per-protocol populations are represented. Considering multiple outcomes, time points, and analysis populations can create interpretive complexity: results may differ across measures, and testing many hypotheses can increase the chance of a seemingly notable result arising by chance. This is a general concern, not a claim that a particular multiplicity problem occurred in this trial.

The registry record does not report a testing hierarchy, multiplicity adjustment, or the way the primary and secondary analyses were prioritized. It also does not report whether analyses across time points were prespecified or how repeated measurements were handled. Without these details, the evidential role of any individual secondary result cannot be determined from the record.

Missing-data methods are not reported in the registry record. The record does not state how participants without an endpoint assessment were classified, whether any imputation was used, or whether sensitivity analyses tested alternative assumptions. For a binary closure outcome, the treatment of unknown status can affect group proportions and the estimated comparison. The number and pattern of missing assessments are also not reported in the registry record.

The record names modified intent-to-treat and per-protocol populations, but does not provide their definitions or population-specific outcome estimates. These omissions limit assessment of how exclusions, adherence, and unavailable assessments may have affected results. No particular analytic choice should be inferred from the population labels alone.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: cellulitis, right leg (1.5%), anasarca (1.5%), bilateral pleural effusions (1.5%), acute respiratory failure (1.5%), cystitis (1.5%).

The registry reports descriptive adverse-event counts by arm. In the Mirragen arm, 6 participants were listed as having a serious adverse event among 67 at risk, and 5 were listed with other adverse events among 67 at risk; the record lists 1 death. In the Fibracol arm, 3 participants were listed as having a serious adverse event among 66 at risk, and 5 were listed with other adverse events among 66 at risk; the record lists 0 deaths.

The serious-event terms listed include cellulitis, right leg; anasarca; bilateral pleural effusions; acute respiratory failure; cystitis; and deep space infection of left plantar mid foot. Each listed term is accompanied by 1.5% in the registry record. These entries describe reported events; they do not establish that a dressing caused an event. The record does not provide a causal attribution or a comparative statistical analysis for these terms.

Counts and at-risk denominators should be read as descriptive safety information, not as proof of a difference or equivalence between groups. A comparative interpretation would require a defined analysis and uncertainty estimates, which are not reported in the registry record. The listed deaths should likewise be read as counts, without assuming cause or relationship to treatment.

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

The registry record establishes that a randomized, prospective, multicenter comparison was conducted between a Mirragen-based dressing strategy and a Fibracol-based dressing strategy, each used with standard wound care. It defines complete wound healing at 12 weeks as the primary outcome and records that the trial is completed. These details identify the comparison and the intended outcome, but they do not amount to a reported estimate of comparative healing.

The posted outcome information is not reduced to a single primary comparison. As a result, the record does not show the group-specific primary healing proportions, the difference between them, or the precision of that difference. It cannot support a conclusion that one strategy produced more or less healing, nor can it establish that the strategies had similar outcomes. A missing comparative estimate should not be interpreted as a null result.

The safety information provides counts of participants with serious and other adverse events and a death count in each arm. Those figures are descriptive. Without details of event attribution, follow-up completeness, definitions, and comparative analysis, they do not establish whether an event was caused by a dressing or whether safety differed between strategies.

General interpretation of a randomized trial would consider the estimated effect, its confidence interval, the outcome definition, missingness, analysis populations, and the conduct of the trial. Here, important details—including the statistical plan and missing-data methods—are not reported in the registry record. The labels modified intent-to-treat and per-protocol do not resolve those uncertainties without definitions and corresponding estimates.

The record therefore supports a description of the trial design, endpoint, and reported adverse-event counts. It does not, as recorded, support a numerical statement about comparative efficacy or a firm comparative safety conclusion. That distinction is important: the existence of a completed randomized study and a defined outcome is not a substitute for outcome estimates and their uncertainty.

13. Why This Trial Matters Statistically

This trial is statistically relevant because it compares two dressing strategies within a shared standard-care context and uses random assignment. That design targets a comparative question rather than simply describing outcomes after use of a single product. The primary endpoint, complete wound healing at 12 weeks, is a participant-level binary outcome that can be summarized as group-specific proportions and a contrast between groups.

The record also illustrates why a named primary endpoint is not enough for interpretation. A useful result requires the actual group outcome information, a clearly identified analysis population, a defined comparison, and an uncertainty measure. The registry record does not reduce its primary outcome information to one comparison, so readers cannot assess the magnitude or precision of a healing contrast from the posted information.

Including both modified intent-to-treat and per-protocol populations raises an important analytic issue. Different populations may reflect different estimands and assumptions, particularly when adherence or outcome availability varies. Reporting their definitions and results would help readers understand whether conclusions depend on analytic choices. Those details are not reported in the registry record.

The range of secondary outcomes adds further dimensions to the trial question. Percentage area reduction, time to heal, quality of life, and pain can capture aspects of outcome beyond complete closure, but multiple measures require a clear plan for interpretation and multiplicity. The registry does not report that plan.

Finally, the adverse-event counts show why descriptive safety information should be separated from causal or comparative claims. Counts can inform what was recorded in each arm, but they do not replace a prespecified safety analysis or account for uncertainty. This trial therefore offers a useful example of the distinction between a defined randomized design and the fuller statistical reporting needed to interpret results.

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 registry record does not provide a single comparative estimate for the primary endpoint, despite defining complete wound healing at 12 weeks. This is the central limitation for interpreting efficacy: the posted information does not establish the size, direction, or precision of a difference between the dressing strategies.

Further details needed to assess the outcome are not reported in the registry record. These include the operational definition and confirmation process for complete closure, group-specific endpoint counts, and the handling of participants without an outcome assessment. Missing-data methods and sensitivity analyses are also not reported, so the effect of unavailable outcome information cannot be evaluated.

The record identifies modified intent-to-treat and per-protocol populations but does not define them or provide their separate outcome estimates. It does not identify which population served as the principal analysis for the primary comparison. The statistical model, covariate adjustments, randomization implementation, and allocation-concealment procedures are not reported in the registry record.

Masking is listed as none. Whether outcome assessors had separate masking arrangements is not reported. This is relevant context for an endpoint involving assessment of wound closure, though the record does not establish that assessment bias occurred.

The multiplicity strategy for the primary and secondary outcomes is not reported. Nor does the registry provide a detailed sample-size justification or enough information to assess the planning illustration’s assumptions and numerical outputs. The adverse-event counts are not accompanied by a comparative analysis or attribution details. These limitations constrain interpretation of efficacy and safety; they do not, by themselves, show that the trial was biased or that a particular result occurred.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers — NCT06403605.
• Registry record last updated 2025-11-10; status last verified 2025-10.
• Results first posted 2025-11-10.
• 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

NCT06403605 is a completed, prospective, multicenter, randomized, parallel-group trial sponsored by ETS Wound Care, LLC. It compared a Mirragen Advanced Wound Matrix primary dressing strategy with a Fibracol primary dressing strategy, with standard wound care described in both arms. Enrollment was 148. Masking is listed as none.

The registry defines the primary outcome as complete wound healing, measured as the proportion achieving complete wound closure at 12 weeks. It says that modified intent-to-treat and per-protocol populations are represented. Secondary outcomes include percentage area reduction, time to heal, quality of life, and pain.

The posted results do not reduce the primary outcome information to a single comparative estimate. The registry lists adverse-event counts by arm, but no comparative safety analysis is reported. Details of the statistical plan, missing-data methods, multiplicity handling, and analysis-population definitions are not reported in the registry record.