High Purity Type I Collagen Based Skin Substitute Vs Dehydrated Human Amnion/Chorion Membrane in Treatment of DFUs: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for High Purity Type I Collagen Based Skin Substitute Vs Dehydrated Human Amnion/Chorion Membrane in Treatment of DFUs (NCT06470087), a randomized na study. The primary outcome is Percentage Wound Area Epithelialization From Week 1 Through 4.

2. Clinical Question

The comparison concerns two wound-care approaches, each combining standard care with an advanced wound-covering product. It is not a comparison of either product with no treatment or with standard care alone. The record lists complete wound closure and repeat applications as secondary outcomes. It does not report a longer follow-up period, so the findings address only the stated 4-week timeframe. Details such as ulcer duration, baseline wound characteristics, other eligibility criteria, and how standard care was otherwise delivered are not reported in the registry record.

3. Trial Design

This was a randomized, parallel-group clinical trial with no masking. The registry lists 28 participants enrolled and describes the study as completed. Fourteen participants were assigned to standard of care with a Type-I collagen-based skin substitute, and 14 to standard of care with human amnion/chorion membrane. The record identifies the sponsor as Adichunchanagiri Institute of Medical Sciences, B G Nagara.

The study start date was 2024-06-03, and the primary completion date was 2024-09-15. The primary outcome timeframe was 4 weeks. The record describes the collagen product as applied weekly or as needed, with a padded dressing afterward. For the amnion/chorion membrane group, the record also describes a padded dressing after application. The available description of the collagen arm's dressing is truncated, limiting a complete comparison of the dressing regimens.

Random allocation is a design feature intended to reduce systematic differences between groups, but the registry record does not report how the sequence was generated, whether allocation was concealed, or how assignment was implemented. Masking was listed as none; the record does not explain whether outcome assessors were masked. The record does not report the original sample-size justification, the planned analysis population, handling of missing data, or a detailed statistical analysis plan. The trial phase is listed as not applicable. No additional trial-design details should be inferred from that designation.

Because the groups received distinct wound products and the study was unmasked, expectations or knowledge of assignment could potentially influence care or measurement; whether that occurred is not reported. The outcome was measured manually from digital photographs, but procedures for image assessment, assessor training, or reproducibility are not reported in the registry record. These omissions limit assessment of how consistently the endpoint was measured across groups.

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

Analysis population for the primary outcome, as defined in the registry: The number given indicates the average change in wound area in both the groups between baseline and week 4. Since in all the study participants the wound area has decreased, the value in the table indicates average decrease in wound area in both the groups.

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.

6. Primary Endpoint

The registry lists the primary outcome as Percentage Wound Area Epithelialization From Week 1 Through 4, measured over 4 weeks.

The primary endpoint is titled percentage wound area epithelialization from week 1 through 4. The registry describes manual measurement using digital photography and gives a calculation based on epithelialized area divided by total wound area, multiplied by 100. In general, epithelialization describes the development of epithelial tissue over a wound surface, and expressing this as a percentage relates the measured area to the total wound area.

The record also says the values indicate average change in wound area between baseline and week 4 and that wound area decreased in all participants. This description does not align neatly with the endpoint title and calculation, which refer to percentage epithelialization. The record does not clarify whether the posted arm values are percentages of wound area epithelialized, percentage changes from baseline, or another summary of wound-area change. That ambiguity matters when interpreting the size and direction of the group contrast.

For a wound-care comparison, an area-based measure can provide a numerical description of change over a defined follow-up period. It does not by itself capture every aspect of wound status, patient experience, or durability of closure. The registry record reports a group mean and standard deviation for each arm, but does not provide individual measurements or further measurement details. Complete closure is listed separately as a secondary outcome, distinguishing that outcome from the continuous primary measure.

7. Results Posted in the Registry

• SOC and Human Amnion/Chorion Membrane: mean 77.71 versus 93.62 on control; difference -15.91 (95% CI -16.07 to -15.75), standardized effect d = -73.86; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Proportion of Subjects That Obtain Complete Closure Over 4-week Treatment Period

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • SOC and Human Amnion/Chorion Membrane: 50.0% (7/14) versus 71.4% (10/14) on control; risk difference -21.4 percentage points (95% CI -56.7 to 13.9), risk ratio 0.70 (0.38–1.30); unadjusted two-proportion z-test p = 0.246.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between SOC and Human Amnion/Chorion Membrane and the control. The interval gives the range of effects that remain compatible with the data.

Percenatge of Participants Undergoing Repeat Applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane Used to Obtain Wound Closure

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • SOC and Human Amnion/Chorion Membrane: 28.6% (4/14) versus 35.7% (5/14) on control; risk difference -7.1 percentage points (95% CI -41.6 to 27.4), risk ratio 0.80 (0.27–2.37); unadjusted two-proportion z-test p = 0.686.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between SOC and Human Amnion/Chorion Membrane and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists two secondary outcomes: complete closure during the 4-week treatment period and repeat applications of the advanced wound product or membrane used to obtain closure. Together, these outcomes add information about whether wounds reached closure and whether repeated product applications were recorded. They are related to the primary area-based measure but are not interchangeable with it. A wound-area summary can change without complete closure, and closure status does not describe the extent or trajectory of area change. Repeat application is a treatment-process measure rather than a direct measure of wound healing by itself.

Across the secondary outcomes, the observed group contrasts are not conclusive: their intervals include no difference and the unadjusted p-values do not provide strong evidence against a null contrast. The directions of the point estimates are not a consistent confirmation of the primary contrast. This overall pattern means the secondary outcomes neither clearly corroborate nor overturn the primary result. Their estimates remain compatible with a range of possible group differences, reflecting the limited information in the small groups.

Secondary findings deserve less weight than a clearly prespecified primary analysis because multiple outcomes create more opportunities for chance findings. The registry does not report whether these outcomes were prespecified in a statistical plan, how many hypotheses were intended, or whether multiplicity was addressed. The record lists 6 outcome measures but posts results for 2 secondary outcomes. It is not clear from the registry record how the other measures relate to the analysis plan or whether they were collected, analyzed, or omitted from reporting.

These outcomes should be considered supportive and exploratory in the context of the available record, not as independent proof of a treatment difference. Their interpretation also depends on clear definitions of closure, repeat application, assessment timing, and missing observations. Those procedural details are not fully reported. A future confirmatory analysis would need transparent outcome definitions and a prespecified hierarchy or multiplicity strategy to clarify how secondary results contribute to overall inference.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Proportion of Subjects That Obtain Complete Closure Over 4-week Treatment Period
• Percenatge of Participants Undergoing Repeat Applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane Used to Obtain Wound Closure

9. Statistical Interpretation

10. Statistical Methods Explained

A continuous outcome is measured on a numeric scale, rather than being limited to categories such as closed or not closed. The registry classifies the primary outcome as a mean with standard deviation. A mean gives a group-level average, while a standard deviation describes variation among observations around that average. They answer different questions: the mean describes the central level, and the standard deviation describes the spread of individual values. Neither alone shows the full distribution of participant outcomes.

What does the mean difference express?

A mean difference compares the average outcome in one group with the average in the other, using a stated group order. The posted contrast is for the human amnion/chorion membrane group relative to the Type-I collagen-based skin substitute group. Its negative sign follows from the ordering of the reported means. The estimate is expressed in the endpoint's reported scale; it is not a relative percentage or a ratio. Interpretation depends on knowing what that scale represents. In this record, the title and calculation refer to percentage wound-area epithelialization, while the outcome description also calls the values average change or decrease in wound area. The record does not resolve this inconsistency.

What does a confidence interval describe?

In general, a confidence interval describes uncertainty in an estimated effect under the statistical procedure used. It gives a range of values reasonably compatible with the observed data and the method's assumptions. A narrower interval indicates greater precision under those assumptions; it does not eliminate bias, measurement error, or ambiguity in the outcome definition. The primary contrast's interval does not include zero, while the intervals for the posted secondary risk differences do include zero. This is a distinction in the numerical results, not proof that one outcome is important and another is not.

How should the p-values be read?

A p-value describes how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the analysis assumptions held. It is not the probability that the null hypothesis is true, nor a measure of the size or clinical importance of an effect. The primary comparison has an unadjusted p-value < 0.001. Secondary comparisons are also reported with unadjusted p-values. The registry does not describe the test used, whether hypotheses were prespecified, or any adjustment for the number of outcomes and comparisons. Consequently, the p-values should be read as unadjusted summaries rather than as a complete account of confirmatory evidence.

Why do small groups affect interpretation?

With 14 participants in each group, a small number of observations can have substantial influence on group summaries, especially for outcomes with limited possible values or uneven distributions. The record does not provide individual observations, so it is not possible to inspect distributions, outliers, or whether standard assumptions were reasonable. General statistical methods for continuous outcomes often rely on assumptions about the distribution of errors or the sampling behavior of estimates. Which assumptions were checked, and how, are not reported in the registry record.

For binary outcomes, such as whether complete closure occurred, the registry reports counts and compares proportions using a risk difference. In general, a risk difference describes the absolute difference between group proportions. Its confidence interval indicates uncertainty in that difference. Relative measures such as risk ratios and odds ratios describe contrasts on different scales and can yield different numerical impressions, particularly with limited data. The record lists these measures for the secondary comparisons, but it does not report analyses adjusted for covariates.

The standard deviation figures and other posted summaries are not substitutes for participant-level data. Nor does an unadjusted analysis necessarily account for chance differences in baseline characteristics. Randomization helps support group comparability in expectation, but the registry record does not show baseline data or detail the allocation process. The record also does not report how missing measurements, protocol deviations, or withdrawals were handled. Those details matter because analyses based on different participant sets or missing-data assumptions can lead to different estimates.

The posted re-calculations are unadjusted comparisons based on the recorded summary statistics. No discrepancy is flagged between the sponsor's posted result and the re-calculated result. However, the registry lists no reported analyses, and it does not explain the source analysis method in detail. The comparison statistics therefore should not be mistaken for a full reconstruction of the trial's prespecified analysis. A statistical result is most informative when its outcome definition, analysis population, assumptions, and decision rules are clear; several of those details are not reported in this registry record.

11. Confidence Intervals and Precision

Precision concerns how tightly an estimate is determined by the data under the analysis method. The primary mean difference is -15.91, with a confidence interval from -16.07 to -15.75. This interval is relatively narrow around the estimate, indicating limited sampling uncertainty according to the reported calculation. That description is conditional on the endpoint being correctly defined and measured and on the analysis assumptions being appropriate. It does not address systematic measurement error or whether the endpoint is clinically meaningful.

The secondary confidence intervals are much wider relative to their point estimates. For complete closure, the risk difference is -0.214, with an interval from -0.567 to 0.139. For repeat applications, the risk difference is -0.071, with an interval from -0.416 to 0.274. Each interval includes zero and spans values in both directions. The observed data therefore leave substantial uncertainty about the direction and size of these secondary group differences.

Precision is affected by the number of participants and by the variability or frequency of the outcome. Each arm included 14 participants. For binary outcomes, a few participants can materially affect the estimated proportions when groups are this small. The registry does not report missing data or participant-level outcomes, so the influence of any incomplete observations cannot be assessed. Narrowness of the primary interval should not be read as resolving the discrepancy in endpoint wording or as proof that all sources of uncertainty are small. Confidence intervals quantify only the uncertainty captured by the calculation, not every limitation of the trial.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size estimates are planning illustrations based on the observed effects, not the trial's original design rationale. The original design assumptions and sample-size justification are not reported in the registry record. The planning method assumes a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It considers detecting the stated fraction of the observed effect. Because these outcomes are not time-to-event outcomes, the estimates are participants per arm, not total events.

The 80% power column describes the planned number of participants per arm for a design with an 80% chance of detecting the specified effect if that effect and the planning assumptions were true. The 90% column uses a higher chance of detection, and therefore generally calls for more participants. These are design calculations, not guarantees that a future study will detect an effect. They are not observed power.

The primary continuous-outcome illustration gives 1 participant per arm for each of the listed fractions of the observed effect. Such outputs are highly dependent on the observed estimate and recorded variability and should not be treated as a practical sample-size recommendation. For complete closure, the estimates range from 81 to 306 participants per arm for 80% power and from 108 to 409 for 90% power, across the listed effect fractions. For repeat applications, the corresponding ranges are 670 to 2,758 and 897 to 3,692 per arm. Smaller target effects require more participants than larger target effects, all else equal. These figures are planning illustrations only; they do not describe the number actually enrolled, which was 28.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -15.910; pooled standard deviation σ = 0.215.
2. n = 2 × (1.96 + 0.842)² × 0.215² / -15.910² = 0.0, rounded up to 1 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -15.91                      # observed difference in means
sigma <- 0.21540659228538                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(6470087)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 1 (80% power), 1 (90% power)
 75% of observed effect: n per arm = 1 (80% power), 1 (90% power)
 50% of observed effect: n per arm = 1 (80% power), 1 (90% power)
power.t.test: 1.3 
Simulated power at n = 1 per arm: NA (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when several outcomes, time points, or comparisons are tested. Even when no underlying group differences exist, conducting many tests increases the chance that at least one result appears statistically notable by chance. The registry lists 6 outcome measures and posts the primary outcome and 2 secondary outcomes. It does not report a multiplicity adjustment, a hierarchy for testing outcomes, or a statistical analysis plan specifying which comparisons were confirmatory. The posted p-values are unadjusted. They should therefore not be interpreted as if the record establishes control of the overall false-positive risk across all outcomes.

The absence of a reported multiplicity procedure does not prove that none was planned or used; it means the procedure is not reported in the registry record. Likewise, the record does not explain the status or results of the other outcome measures. The registry lists no reported analyses. It is not possible to determine whether outcomes or analyses changed after trial initiation, or whether results were selected for posting, because these details are not reported.

Missing-data handling is also not reported. The record does not state whether every randomized participant completed follow-up, whether all participants contributed to each endpoint, how incomplete photographs or measurements were treated, or whether any imputation or sensitivity analysis was used. The arm summaries list 14 participants each, but that does not establish that the same participant set contributed to every outcome or that no observations were missing. The distinction between enrolled, randomized, treated, and analyzed participants is not described.

The record also does not specify an intention-to-treat or per-protocol analysis population, how protocol deviations were handled, or whether the primary analysis adjusted for baseline factors. It does not report detailed participant flow or baseline characteristics. These omissions limit assessment of selection, attrition, and comparability after randomization. They also constrain reproducibility: readers cannot fully reconstruct the analysis or determine whether alternative reasonable choices would materially change the estimates.

15. 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 reports no participants affected by serious adverse events in either group. It also reports no participants affected by other adverse events and records zero deaths in each group. Fourteen participants were listed at risk in each arm for both serious and other adverse events.

These figures describe what the registry reports for the recorded safety categories. They should not be read as proof that no unwanted events occurred under any definition or during any period. The record does not provide event-level descriptions, severity grading beyond the serious-event category, relatedness assessments, collection procedures, or details about the safety observation window. It also does not report how participants with incomplete safety follow-up were handled. No serious adverse-event terms are listed.

With 14 participants per group, the safety record is limited in its ability to characterize uncommon events. The absence of recorded events in these groups cannot establish that an event is impossible or that the approaches have equivalent safety. The figures are a concise registry report, not a comprehensive safety evaluation.

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

The posted primary result is a group-level comparison of an area-related measure over 4 weeks. The reported means differ, and the unadjusted confidence interval for the mean difference does not include zero. This is evidence of a numerical separation in the posted summaries under the calculation used. It is not, by itself, a complete interpretation of treatment benefit: the registry's wording is inconsistent about whether the measure represents percentage epithelialization or change in wound area.

The result does not establish what would happen over a longer period, whether wounds remained closed, or whether participants experienced outcomes not captured by the listed measures. The registry record does not report patient-reported outcomes, longer-term follow-up, or detailed baseline ulcer characteristics. The two secondary outcomes provide additional short-term information, but their estimates are imprecise and do not clearly resolve the interpretation of the primary comparison.

Randomization is a strength for comparing groups, but the record does not report sequence generation or allocation concealment, and masking was listed as none. The study enrolled 28 participants, with 14 in each arm. Small groups make results sensitive to individual observations and limit how broadly findings can be generalized. The trial also reports no detailed analysis plan, missing-data methods, or analysis populations. Those limitations do not erase the observed data, but they restrict the strength of conclusions that can be drawn from them.

Accordingly, the result should be understood as a short-term finding from this completed randomized trial, with uncertainty about endpoint interpretation and incomplete reporting of methods. It does not prove that either approach is superior, equivalent, or ineffective in other circumstances. It does not establish outcomes for populations or care settings not described in the registry. Statistical evidence, measurement quality, clinical relevance, and reproducibility are distinct considerations; the registry record gives only partial information about several of them.

17. Why This Trial Matters Statistically

This trial illustrates how outcome wording is not a minor editorial detail. The primary measure is titled percentage wound area epithelialization and includes a formula based on epithelialized area, yet the registry also describes the group values as average decrease in wound area from baseline. Those concepts may not yield the same interpretation. A clear operational definition is needed to understand the scale, direction, and meaning of an estimate, even when the arithmetic contrast is precise.

The record also shows the difference between statistical precision and broader evidential strength. The primary confidence interval is narrow, while important details about measurement, analysis population, missing observations, and the original analysis plan are not reported. A narrow interval can reflect precision under a calculation, but cannot compensate for uncertainty about what was measured or how data were selected and analyzed.

Small randomized studies can generate useful preliminary estimates, while still leaving considerable uncertainty for binary and safety outcomes. The secondary results and adverse-event counts are based on 14 participants in each group. These data are informative as registry observations but do not characterize uncommon outcomes or provide definitive estimates across settings. Planning estimates based on observed effects can also be unstable, especially when an estimate is derived from a small study.

Finally, this record highlights why transparent reporting matters. Clear allocation methods, participant flow, outcome definitions, analysis populations, missing-data procedures, and multiplicity plans help readers distinguish prespecified evidence from exploratory findings. Their absence does not imply misconduct or that the methods were inadequate; it means readers cannot evaluate those aspects from the registry record. Statistical interpretation is strongest when numerical results and the procedures that produced them are both described.

18. 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.

Several limitations are specific to the information recorded for this trial. The primary outcome has inconsistent wording: the title and formula refer to percentage epithelialization, while the accompanying description says the values indicate average change or decrease in wound area. The record does not explain how the posted values map to that formula, so the endpoint's exact interpretation is uncertain.

The study was unmasked, and the primary measurement was made manually using digital photography. The record does not state whether image assessors were masked, how measurements were standardized, or whether repeated assessments were checked for agreement. The available arm description for the collagen group is truncated, so the full dressing regimen cannot be compared from the record. Detailed eligibility criteria, baseline wound characteristics, and participant flow are also not reported.

The groups were small, with 14 participants in each arm. The record does not report the original sample-size justification, allocation sequence methods, concealment procedures, statistical analysis plan, or analysis populations. Missing-data handling and sensitivity analyses are not reported. It is therefore not possible to assess whether all participants contributed to each measure or how incomplete data may have affected results.

The follow-up described for the primary and secondary outcomes is 4 weeks. Longer-term closure, recurrence, and other outcomes are not reported in the posted results. The registry lists 6 outcome measures, but reports results for the primary and 2 secondary outcomes, with no reported analyses listed. It does not explain the status of the other measures or any approach to multiplicity. These gaps limit reproducibility and the strength of conclusions that can be drawn from the registry record.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: High Purity Type I Collagen Based Skin Substitute Vs Dehydrated Human Amnion/Chorion Membrane in Treatment of DFUs — NCT06470087.
• Registry record last updated 2025-11-14; status last verified 2025-11.
• Results first posted 2025-01-06.
• 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.

22. Record Summary

NCT06470087 is a completed randomized, unmasked, parallel-group trial of standard care with a Type-I collagen-based skin substitute versus standard care with human amnion/chorion membrane for diabetic foot ulcers. The registry lists 28 participants enrolled, with 14 in each group. The primary outcome concerns percentage wound-area epithelialization over 4 weeks, although the accompanying description also characterizes the values as average wound-area decrease.

The posted primary means are 93.62 and 77.71, with a mean difference of -15.91 and a 95% confidence interval from -16.07 to -15.75; the unadjusted p-value is < 0.001. Two secondary outcomes are posted, while no reported analyses are listed. Serious adverse events, other adverse events, and deaths are recorded as zero in both groups. Important details about outcome interpretation, allocation, missing data, analysis populations, and multiplicity are not reported in the registry record.