Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers (NCT01549860), a randomized na study. The primary outcome is Wound Area Mean Percent Reduction.

2. Clinical Question

3. Trial Design

This completed study is registered as NCT01549860, with the title “Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers.” Its official title is “IN-BALANCE VLU Inflammation, Bacteria, & Angiogenesis Effects in Launching Venous Leg Ulcer Healing.” Celleration, Inc. is listed as sponsor. The registry describes the design as randomized, single-masked, and parallel-group. The phase is listed as not applicable.

The study compared MIST Therapy plus standard care with standard care alone in subjects with chronic lower-extremity venous ulcers. Both groups received compression, wound dressings, and debridement as needed. The standard-care description allows a minimum of one treatment per week and up to 3 times per week at investigator discretion for four weeks. The combined-treatment group received non-contact low-frequency ultrasound 3 times per week for four weeks, in addition to standard care. Further details about masking procedures and how randomization was implemented are not reported in the registry record.

The registry lists enrollment of 156. The primary outcome record is based on 40 participants in the Standard Care group and 41 in the SC + Mist Therapy group. How these endpoint denominators relate to total enrollment, including reasons for participants not appearing in the posted primary results, is not reported in the registry record. The study start is listed as 2012-04, primary completion as 2014-05, and status as completed.

The primary endpoint was assessed four weeks after the baseline, or randomization, visit. Secondary outcomes listed include healing rates and change in Pain VAS Scores. The posted healing count is at twelve weeks after randomization. How pain scores were analyzed, and the full details of outcome assessment and follow-up, are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: 156 subjects were consented for the study, 112 subjects met the major inclusion/exclusion criteria (study cohort), 81 subject were randomized (reduced \<30% during run-in period).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: eligible subjects that were randomized

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: Eligible subjects randomized

6. Primary Endpoint

The registry lists the primary outcome as Wound Area Mean Percent Reduction, measured over 4 weeks post baseline visit (randomization visit).

The primary endpoint is wound area mean percent reduction, assessed four weeks after the baseline visit at randomization. It measures the percentage reduction in wound size, summarized as a mean for each group. A larger percentage reduction represents a greater average reduction in measured wound area over the assessment interval; it does not, by itself, establish complete healing for an individual participant.

The registry frames the primary question as a comparison of the mean percentage reduction in the two groups. Its stated null hypothesis is that the group means are equal, and its alternative is that they differ. Because the alternative is two-sided, the question is not restricted to whether one particular group has a larger reduction. The outcome is continuous, and the posted group summaries give a mean and standard deviation.

A continuous measure can preserve information about the amount of change rather than reducing every participant's course to a healed/not-healed category. Mean change can describe the average response in each group, while the standard deviation describes variation among participants. These are general statistical reasons to use a continuous endpoint. The registry does not report the measurement procedures, rules for handling wounds with missing measurements, or whether the endpoint used one wound per participant when multiple wounds were present. Those details are not reported in the registry record.

7. Results Posted in the Registry

• SC + Mist Therapy: mean 61.60 versus 45.80 on control; difference 15.80 (95% CI 2.40 to 29.20), standardized effect d = 0.51; z-test p = 0.021.

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.

Heal Rates

• 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:
  • SC + Mist Therapy: 39.0% (16/41) versus 25.0% (10/40) on control; risk difference 14.0 percentage points (95% CI -6.1 to 34.1), risk ratio 1.56 (0.81–3.02); unadjusted two-proportion z-test p = 0.176.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between SC + Mist Therapy and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcomes are intended to add context to the primary comparison, but they do not measure precisely the same thing. The registry lists healing rates and change in Pain VAS Scores as secondary outcomes. A healing count is posted at twelve weeks after randomization, while the primary endpoint is mean wound-area reduction at four weeks. The pain outcome is listed, but its result is not reported in the registry record.

Across the reported primary and secondary results, the estimated directions are compatible with greater improvement in the SC + Mist Therapy group. However, the healing comparison is less statistically conclusive: its unadjusted interval includes zero, and its unadjusted p-value does not provide the same evidence against no difference as the primary comparison. This should not be treated as a contradiction. The endpoints differ in measurement scale and follow-up time, and a group-level mean reduction in wound area is not equivalent to the proportion of participants classified as healed.

Secondary outcomes generally carry less confirmatory weight when there are several outcomes or comparisons and no reported multiplicity strategy. Testing multiple outcomes can increase the chance of at least one apparently notable result by chance. General statistical practice addresses this by prespecifying a hierarchy or using an adjustment, but whether either approach was used in this study is not reported in the registry record. The record lists 3 outcome measures and 2 analyses; the relationship between all listed outcomes and the posted analyses is not fully explained.

The secondary results can therefore be read as supportive context, not as a replacement for the primary endpoint or as independent proof of a consistent effect across all outcomes. The absence of a posted pain result also limits any assessment across the full set of listed secondary outcomes. Statistical interpretation should keep the endpoint definitions, timing, uncertainty, and incomplete reporting in view.

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

• Heal Rates
• Change in Pain VAS Scores

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is continuous: mean percentage reduction in wound area. For each group, the registry posts a sample size, a mean, and a standard deviation. The mean is the arithmetic average of the measured values in that group. The standard deviation describes the spread of individual measurements around that average. General statistical interpretation: a larger standard deviation indicates more variability among observed values, while the mean describes only the center of the group distribution.

What does a difference in means express?

The comparison is expressed as the mean in the SC + Mist Therapy group minus the mean in the Standard Care group. The posted estimate is 15.8. This is a difference between group averages, not a statement that every participant's wound-area reduction differed by that amount. It is also not an adjusted estimate: the recalculation uses the posted group summaries and does not incorporate participant-level data or covariates. The registry's endpoint description specifies a comparison between randomized groups, and its reported analysis is a two-sided t-test.

What does a two-sided t-test assess?

General explanation: a two-sided t-test evaluates whether the observed difference in group means is unusual under a null model in which the population means are equal. It considers departures in either direction, consistent with the registry's alternative hypothesis that the means differ. A p-value summarizes how compatible the observed result is with that null model under the test's assumptions; it is not the probability that the null hypothesis is true, nor does it measure the size or importance of an effect.

The registry reports the sponsor's two-sided t-test as p < 0.024. A separate unadjusted recalculation from the posted summaries gives p = 0.021. The registry does not report further detail about the sponsor's test specification, such as whether equal variances were assumed, so that detail is not reported in the registry record. General explanation: t-test procedures compare means while accounting for the amount of variability and the number of observations. Their exact behavior depends on the chosen test specification and the data.

Why consider the confidence interval?

A confidence interval gives a range of estimates compatible with the data under the procedure used. The recalculated 95% interval for the mean difference is 2.395 to 29.2. In general, an interval that excludes zero is consistent with a two-sided test finding evidence of a difference at the corresponding conventional level, when both use compatible assumptions. The interval also conveys uncertainty about the magnitude: the posted data are compatible with a range of positive mean differences, not only with the point estimate of 15.8.

The recalculation is unadjusted and based on the reported means, standard deviations, and group sizes. It is not an analysis of individual participant observations. The registry does not report whether its own analysis used any adjustment, how deviations from assumptions were assessed, or what procedures were used for missing measurements. These methods are not reported in the registry record.

Why does variation matter?

General explanation: greater variation makes a group mean less precise, all else equal, because individual results are more dispersed around the average. The primary group standard deviations are 32.5 and 28.9, and the posted group sizes are 40 and 41. These summaries inform the uncertainty around the difference. A mean alone would not show how variable wound-area reductions were among participants. Conversely, a standard deviation is not a confidence interval for the mean or for the difference between groups.

Over-dispersion is a general concern mainly for count outcomes when the observed counts vary more than a chosen model expects. The primary endpoint is continuous, and the record does not describe a count model for it. It would therefore be inappropriate to assert that over-dispersion affected the primary analysis. More generally, any modeling concern must be matched to the actual outcome and analysis; the registry does not report diagnostics for the primary endpoint.

How is the secondary comparison different?

Healing is posted as a participant count at twelve weeks, making it a binary outcome at the participant level: participants are counted according to whether they are recorded as healed. The recalculated comparison is expressed as a risk difference, the difference between the proportions in the two groups. General explanation: risk differences state the absolute difference in event proportions, whereas relative measures such as risk ratios compare the proportions multiplicatively. They answer different questions and can give different impressions of the same data. The posted unadjusted interval for the risk difference crosses zero, and its p-value is 0.176.

The secondary outcome uses a different follow-up time and estimand from the primary continuous measure. The registry also lists change in Pain VAS Scores as a secondary outcome, but a corresponding result is not reported in the registry record. No details about a multiplicity procedure are reported. Therefore, the posted unadjusted secondary result should be treated as exploratory rather than as an independent confirmatory test. The record does not report whether a prespecified hierarchy or adjustment was used.

11. Confidence Intervals and Precision

The primary recalculated 95% confidence interval for the difference in mean percentage wound-area reduction is 2.395 to 29.2. The estimate is 15.8. The interval expresses uncertainty about the size of the group difference, given the posted summaries and the recalculation method. It does not mean that 95% of participants had outcomes within that range. In general, a confidence interval is a range produced by a procedure that, under its assumptions, would cover the target parameter at the stated rate over repeated samples.

The interval lies above zero, so its range is compatible with a positive difference under this unadjusted calculation. But its span also shows that the data do not pin down one precise magnitude. The estimate should not be treated as exact, and the interval does not account for uncertainty arising from unreported design choices, missing data, measurement procedures, or departures from the statistical assumptions. The registry does not provide a sponsor-reported confidence interval for the primary comparison.

For the secondary healing comparison, the recalculated confidence interval for the risk difference is -0.060 to 0.341. It crosses zero, so the posted counts are compatible with a range that includes no difference as well as differences in either direction. This wider uncertainty cautions against interpreting the observed direction as a settled estimate. Because this endpoint is binary and measured at twelve weeks, its interval is not directly comparable to the primary interval, which concerns a continuous mean at four weeks.

Precision depends on sample size and variability, as a general statistical principle. The primary results use 40 and 41 participants, and the posted standard deviations are 32.5 and 28.9. The enrollment figure is 156, but the record does not explain the relation between enrollment and the endpoint denominators. Wider or narrower intervals should be understood in light of the particular endpoint, its scale, its observed variability, and the analysis method—not as a stand-alone measure of study quality.

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 planning figures are participants per arm, not total events. They are illustrations based on the observed effect and are not the trial's original design calculations. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each planning scenario uses the stated fraction of the observed effect as the effect to detect.

The 80% power column gives the illustrative number of participants per arm for a design with an 80% chance of detecting the specified effect, if the assumptions and effect size used in that calculation hold. The 90% power column gives the corresponding number for a 90% chance. These are planning concepts: power describes the probability of detecting a specified effect under a statistical model when that effect is real. It is not the probability that the study's conclusion is correct.

The rows consider planning for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. Smaller effects are harder to distinguish from random variation, so the planning illustrations require more participants per arm as the target effect becomes smaller. This relationship is general; the figures depend on the stated assumptions and should not be interpreted as a recommendation or as a reconstruction of the trial's original design.

The record does not report the trial's own sample-size justification or original design assumptions. The displayed planning figures are not observed power; they are prospective illustrations based on the effect estimated from the posted results. Because the observed effect is itself uncertain, planning around it does not guarantee that a future study would obtain the same effect or achieve the stated power.

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 = 15.800; pooled standard deviation σ = 30.730.
2. n = 2 × (1.96 + 0.842)² × 30.730² / 15.800² = 59.4, rounded up to 60 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 <- 15.8                      # observed difference in means
sigma <- 30.7299692915276                     # 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(1549860)
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 = 60 (80% power), 80 (90% power)
 75% of observed effect: n per arm = 106 (80% power), 142 (90% power)
 50% of observed effect: n per arm = 238 (80% power), 318 (90% power)
power.t.test: 60.4 
Simulated power at n = 60 per arm: 0.797 (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. Analyses Reported by the Sponsor

The registry reports the sponsor's primary analysis as a two-sided t-test with p < 0.024. It does not post the sponsor's numerical estimate of the mean difference, its confidence interval, or the test statistic. The posted group means, standard deviations, and sample sizes allow an unadjusted recalculation: the difference in means is 15.8, with a 95% confidence interval from 2.395 to 29.2 and p = 0.021.

These are related but distinct reports. The sponsor's entry is the analysis reported in the registry; the recalculation is a simple comparison from the posted summary statistics and is not a substitute for any participant-level or adjusted analysis. The registry does not report enough detail to establish whether every aspect of the sponsor's test matches the assumptions used in the recalculation. The discrepancy flag is false, and the two reported p-values are close, but the sponsor's own analysis takes precedence if a discrepancy exists between the registry analysis and a summary-statistic recalculation.

Neither p-value describes the clinical importance of the difference. The estimated effect and its uncertainty are needed for that interpretation, and the registry does not provide a threshold for a clinically meaningful change in wound-area reduction. The recalculated interval conveys the precision available from the posted summaries; it does not resolve unreported details about missing observations or analysis populations.

15. Multiplicity, Missing Data and Analysis Populations

The registry states a primary hypothesis comparing mean wound-area reduction between the two groups, and it lists healing rates and change in Pain VAS Scores as secondary outcomes. It also reports 3 outcome measures and 2 analyses. The specific relationship among all outcomes, analyses, and any planned testing sequence is not reported in the registry record. No multiplicity adjustment, gatekeeping strategy, or hierarchy of endpoints is reported.

General explanation: when several hypotheses are tested, the chance of obtaining at least one small p-value by chance can rise. A prespecified approach to multiple testing can control that risk, but the appropriate method depends on the study questions and analysis plan. Without a reported plan, the primary comparison can be distinguished from secondary findings, but the registry does not permit a full assessment of how the overall family of tests was handled. The unadjusted secondary results should therefore be interpreted cautiously.

The record identifies eligible randomized subjects as the primary population, but it does not state whether the reported analyses included every randomized participant, whether participants were analyzed according to assigned group, or whether a per-protocol or other population was used. The primary outcome denominators are 40 and 41; the total enrollment is 156. Reasons for this difference are not reported in the registry record. No flow of participants through randomization, follow-up, and analysis is described in the registry record.

Missing-data procedures are also not reported in the registry record. The record does not state how unavailable wound measurements were handled, whether any values were imputed, or whether sensitivity analyses assessed the effect of missing outcomes. For a continuous endpoint, the handling of missing measurements can affect both group means and uncertainty. For the healing count, the record does not explain whether every randomized participant had an assessed status at twelve weeks or how an unknown status was treated.

These omissions do not prove that the study lacked a prespecified analysis plan or that missing data occurred; they mean those details are not reported in the registry record. As a result, readers can describe the posted group summaries and uncertainty, but cannot fully evaluate adherence to an original statistical plan or the robustness of results to analysis-population and missing-data choices.

16. Safety Results

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

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 0 serious adverse events among 40 participants at risk in the Standard Care group and 0 among 41 participants at risk in the SC + Mist Therapy group. It also lists 0 other adverse events among 40 and 41 participants at risk, respectively. These figures describe the entries in the registry record for the specified groups; they do not establish that no event occurred outside the recorded categories or observation period.

Deaths are not reported in the registry record. The adverse-event entries do not provide event terms, definitions, severity grading, causality assessments, or a detailed observation period. The absence of listed events should therefore be read as the recorded counts, not as a complete characterization of safety. With no listed events in either group, these entries alone cannot estimate comparative risks with useful precision or exclude uncommon harms. They also do not provide a basis for medical advice or for conclusions about safety in other populations.

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

The primary result estimates the difference between group means in percentage wound-area reduction at four weeks. The posted averages and the unadjusted recalculation indicate a positive mean difference, with a confidence interval that excludes zero. This is evidence about the measured group-level endpoint in the participants represented in the posted primary results. It is not a guarantee that an individual participant will have a particular outcome.

The result does not, by itself, show how many participants achieved complete healing by four weeks, because the primary measure is mean area reduction rather than a healed/not-healed count. The separately posted healing outcome uses a later assessment time and a different endpoint. The registry also lists change in Pain VAS Scores, but that result is not reported in the registry record. Longer-term outcomes beyond the listed follow-up periods are not reported.

Statistical evidence against equal group means is not the same as evidence that the difference is clinically important. The registry does not report a threshold for a meaningful change in wound area, and it does not provide the context needed to translate the mean difference into an individual-level expectation. The confidence interval indicates uncertainty in the estimated magnitude; its endpoints are not limits on every participant's possible outcome.

The trial's comparison is between a combination of standard care and MIST Therapy versus standard care alone. The findings therefore concern the comparison as implemented in these groups, including the differing ultrasound exposure and the standard-care schedules described in the registry. They do not isolate the effects of every component, and the registry record does not provide enough detail to assess all features of treatment delivery or adherence.

Finally, the record does not report the analysis population, missing-data method, or original sample-size justification. Those omissions constrain how completely the results can be assessed. The posted estimates can be interpreted as trial results with stated uncertainty, but they do not settle questions about persistence, generalizability, or outcomes not reported in the registry.

18. Why This Trial Matters Statistically

This trial illustrates why a clinical result needs more than a p-value. The primary comparison includes group means, standard deviations, sample sizes, a difference in means, and a confidence interval. Together, these statistics describe both the observed contrast and its precision. The p-value alone would not communicate the estimated size or the range of values compatible with the summary data.

It also demonstrates the importance of distinguishing outcome types. Mean wound-area reduction is continuous and captures average change, while healing status is a participant count at a later time. A favorable direction across related measures does not make them interchangeable: they have different scales, definitions, and follow-up timing. Their uncertainty can also differ.

The record highlights how registry reporting shapes statistical interpretation. Total enrollment is 156, while the primary results list 40 and 41 participants in the two groups. Without an explanation of the analysis denominators, readers cannot establish why those numbers differ. The lack of reported details about missing data, analysis populations, multiplicity, and the original sample-size rationale further limits assessment of robustness and prespecification.

Finally, the planning illustrations show the link between effect size and the number of participants needed under stated assumptions. They are distinct from the original design and from the observed results. Separating planning calculations, sponsor-reported analysis, and recalculation from summary statistics is essential: each answers a different statistical question. This distinction supports a careful reading of evidence without turning a single estimate into a broader claim than the record supports.

19. 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 trial-specific limitations arise from the registry entries. Although total enrollment is 156, the primary endpoint results include 40 participants in the Standard Care group and 41 in the SC + Mist Therapy group. The reason those denominators do not account for the full enrollment is not reported in the registry record. The record does not provide participant flow, the number assessed at each time point, or reasons for any exclusions or unavailable measurements.

The primary outcome is reported at four weeks, and the healing count at twelve weeks. The registry does not report longer follow-up results. Pain VAS Scores are listed as a secondary outcome, but a result is not reported in the registry record. Therefore, the posted findings do not permit a complete assessment of all listed outcomes or of outcomes beyond those time points.

Important analysis details are not reported: the original sample-size justification, missing-data methods, analysis population, any adjustment for baseline variables, and any multiplicity procedure. The registry also does not provide the sponsor's primary effect estimate or confidence interval, nor detailed specifications for the reported t-test. These gaps prevent a full comparison of the sponsor analysis with a participant-level analysis and limit evaluation of sensitivity to analytic choices.

The treatment descriptions indicate that standard care could be delivered at investigator discretion between a minimum of one and up to 3 times per week, while the combination arm received ultrasound 3 times per week. The registry does not report treatment adherence or the distribution of standard-care frequency. The specific masking procedures and measurement methods are also not reported in the registry record. These are reporting limitations; they do not establish that the study failed to use procedures that are simply not described.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers — NCT01549860.
• Registry record last updated 2015-07-30; status last verified 2015-07.
• Results first posted 2015-07-30.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

23. Record Summary

NCT01549860 is a completed, randomized, single-masked, parallel-group study sponsored by Celleration, Inc. It compared standard care with standard care plus MIST Therapy for chronic lower-extremity venous ulcers. Total enrollment is listed as 156.

The primary endpoint was mean percentage wound-area reduction four weeks after baseline. The posted group means were 45.8 for Standard Care and 61.6 for SC + Mist Therapy. The recalculated unadjusted difference was 15.8, with a 95% confidence interval of 2.395 to 29.2 and p = 0.021. The sponsor-reported two-sided t-test is listed as p < 0.024.

A secondary healing count is posted for twelve weeks after randomization. Change in Pain VAS Scores is listed as a secondary outcome, but its result is not reported in the registry record. The record does not report the original sample-size justification, missing-data procedures, analysis population, or multiplicity approach.