This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Polidocanol Versus Glucose Treatment of Telangiectasia Trial (NCT02657252), a randomized phase 4 study. The primary outcome is Change From Baseline in Extent of Telangiectasias.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02657252 |
| Phase | Phase 4 |
| Condition | Varicose Veins, Telangiectasis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 115 |
| Arms in the primary outcome | 2 |
| Lead sponsor | UPECLIN HC FM Botucatu Unesp |
| Results posted | Yes |
2. Clinical Question
Population
The record describes adult women with reticular veins on the side of the thighs and mild venous insufficiency classified as CEAP 1. It concerns telangiectasias of the lower limbs. The primary outcome description specifies that only one lower limb was submitted to treatment. The registry record does not give further eligibility details, such as the severity or extent thresholds for the visible veins, or report how many screened people were excluded.
Intervention
The trial title and brief summary frame the comparison as polidocanol versus glucose sclerotherapy. The summary describes 0,2% polidocanol versus 75% hypertonic glucose. However, the detailed description for the Polidocanol With Glucose arm says 0.2% Polidocanol + 70% Glucose, and the Glucose arm has the same detailed description. The exact treatment contrast therefore cannot be determined from the treatment descriptions in the registry record.
Comparator
The arm labels identify Glucose as the control and Polidocanol With Glucose as the other group. The detailed descriptions for both arms specify the same combination, rather than distinguishing the treatments as the title and brief summary do. This conflict is important when interpreting the comparison: the posted arm labels identify groups, but do not resolve which distinct formulations participants received.
Primary question
The primary outcome is change from baseline in the extent of telangiectasias, measured as a mean continuous outcome at 2 months. The registry describes comparing initial measurements in centimeters with measurements after treatment and labels the unit as percent of change negative values. The posted group means are 57.24 for Glucose and 76.08 for Polidocanol With Glucose. The reported mean difference is 18.84, with a confidence interval from 10.58 to 27.1. The record does not clarify the sign convention or explain how these values map onto disappearance of telangiectasias.
3. Trial Design
The registry identifies NCT02657252 as a Phase 4, randomized, parallel-group clinical trial. Its status is COMPLETED. The stated enrollment is 115. The recorded start is 2015-01, and primary completion is 2016-09. The sponsor is UPECLIN HC FM Botucatu Unesp. The listed conditions are Varicose Veins and Telangiectasis.
The masking field says QUADRUPLE, while the brief summary calls the study triple-blind. These descriptions do not agree, and the registry record does not explain who was masked or how masking was implemented. The allocation is listed as randomized, but the method used to generate or conceal the allocation sequence is not reported in the registry record. The record also does not describe stratification, blocking, or other allocation features.
The brief summary describes a comparison of 0,2% polidocanol with 75% hypertonic glucose. The intervention list names Glucose and Polidocanol with Glucose, while the detailed description for each arm gives the same regimen: 0.2% Polidocanol + 70% Glucose, with a maximum volume of 5 ml. The registry therefore contains conflicting descriptions of what distinguished the assigned treatments. This prevents a confident reconstruction of the treatment contrast from the record alone.
The primary outcome is assessed at 2 months. The arm descriptions also mention a return at a week to investigate adverse effects and a return at 2 months to assess efficacy and adverse effects. The primary outcome population description refers to one treated lower limb. The record does not report the trial's original sample-size justification, detailed statistical analysis plan, or full participant flow through screening, allocation, follow-up, and analysis.
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: Some patients (n=17) were withdrawn because did not appear at the previous scheduled appointments, and were replaced for new ones. In order to avoid loss of individuals we have decided to include 17 more patients.
Overall Study
| Stage | Glucose | Polidocanol With Glucose |
|---|---|---|
| STARTED | 57 | 58 |
| COMPLETED | 47 | 51 |
| NOT COMPLETED | 10 | 7 |
Analysis population for the primary outcome, as defined in the registry: Only one lower limb submited to the treatment.
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.
| Characteristic | Unit | Glucose | Polidocanol With Glucose | Total |
|---|---|---|---|---|
| Participants analysed | 57 | 58 | 115 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 57 | 58 | 115 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 40.7 (SD 10) | 43.6 (SD 10) | 42.2 (SD 10) |
| Sex: Female, Male: Female | Participants | 57 | 58 | 115 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Region of Enrollment: Brazil | Participants | 57 | 58 | 115 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Extent of Telangiectasias, measured over 2 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | percent of change negative values |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled “Change From Baseline in Extent of Telangiectasias.” It is a continuous measure summarized by a mean and standard deviation, with the assessment timeframe recorded as 2 months. The description says that measurements in centimeters at the start are compared with measurements after two months, and that treatment groups are then compared. The population description specifies that only one lower limb was submitted to treatment.
The registry labels the unit “percent of change negative values.” This wording signals that the measure is intended to represent change, but does not clearly state how the sign is assigned or whether a larger positive reported value indicates more disappearance, more residual telangiectasia, or another direction of change. The posted means are positive values, but the record does not explain how those values relate to the phrase “negative values.” That uncertainty limits interpretation of the clinical direction of the contrast.
Using a mean allows the outcome to be summarized across participants on a continuous scale and compared between groups. A mean difference gives the estimated separation between group averages on the reported scale. Its clinical interpretation depends on a clear scale definition, consistent measurement, and a known direction in which change is favorable. The record describes the general measurement approach but does not report instrument details, assessor procedures, or a fuller scoring rule. The endpoint is therefore understandable as a two-month comparison of change in treated telangiectasia extent, while its sign and clinical meaning remain insufficiently specified.
7. Results Posted in the Registry
- Polidocanol With Glucose: mean 76.08 versus 57.24 on control; difference 18.84 (95% CI 10.58 to 27.10), standardized effect d = 0.91; z-test p = <0.001.
Mean difference: Polidocanol With Glucose
95% CI: 10.58 to 27.10
Recalculated from the posted summary statistics
8. Statistical Interpretation
The posted primary results report a mean of 57.24 with a standard deviation of 22.69 for Glucose, based on 47 participants, and a mean of 76.08 with a standard deviation of 18.63 for Polidocanol With Glucose, based on 51 participants. The reported mean difference is 18.84, with a 95% confidence interval from 10.58 to 27.1, and an unadjusted p-value of <0.001. On the recorded scale, the average outcome is higher in the Polidocanol With Glucose group. Whether higher values represent more or less disappearance cannot be established from the registry wording, so the numerical contrast should not be translated into a direction of clinical benefit.
The confidence interval describes a range of values compatible with the observed data under the analysis assumptions. Its endpoints are both on the positive side of zero, and the unadjusted p-value is reported as <0.001. Together, these statistics indicate that the posted group means are separated on the recorded measure. They do not resolve whether the groups received different formulations, because the detailed descriptions for the arms are identical even though the title and summary describe a contrast between polidocanol and glucose.
The record says that the primary outcome is a mean continuous measure, but it does not supply a full statistical analysis plan. The posted comparison is unadjusted in the recalculated summary. Whether the sponsor conducted an adjusted primary analysis, whether the displayed comparison reproduces the trial's prespecified analysis, and whether any analyses were planned but not posted are not reported in the registry record. The record reports zero serious adverse events in each group and reports other adverse events affecting 28 participants in Glucose and 21 in Polidocanol With Glucose. These counts describe posted safety information, not a complete account of event types, severity, timing, or causal attribution.
These results apply to the population and outcome as recorded, with the limitations of the available descriptions. The registry does not report whether all randomized participants contributed to the primary analysis, how missing outcome data were handled, or whether analysis followed assigned treatment. The stated enrollment is 115, while the primary outcome groups list 47 and 51 participants. The record does not explain the difference between enrollment and the outcome group counts. It also does not give the original sample-size assumptions or a full account of protocol adherence. Those omissions limit assessment of precision, potential bias, and the extent to which the posted comparison reflects the intended trial analysis.
The difference is statistically distinct from zero according to the reported interval and p-value, but statistical evidence alone does not establish the clinical importance of the contrast. A clinically meaningful interpretation would require a clear outcome scale, a known favorable direction, and context for what magnitude of change matters. Those details are not reported in the registry record. The inconsistent intervention descriptions also mean that readers should be cautious about attributing the outcome difference to a clearly defined difference in treatment.
9. Statistical Methods Explained
The methods statistics help describe the comparison, but their meaning depends on how the outcome and treatment groups are defined. The registry records a randomized, parallel-group design and reports a continuous primary measure as a mean with standard deviation. The following explanations are general statistical context, followed by the interpretation possible from the posted record.
What does randomization contribute?
In general, random allocation is intended to make treatment groups comparable with respect to both measured and unmeasured characteristics, on average. It supports a causal comparison when allocation is implemented appropriately, participants are analyzed in a suitable way, outcomes are measured consistently, and losses or protocol deviations do not introduce substantial bias. Randomization does not guarantee that every characteristic will be balanced in a particular trial. The registry lists randomized allocation, but the sequence-generation and concealment methods are not reported in the registry record. It also does not state whether the posted analysis preserves the randomized comparison.
A parallel-group design assigns participants to separate groups that remain under their assigned treatment strategy for the comparison. The record labels the study parallel. The primary outcome description refers to one lower limb being treated, but does not provide enough detail to assess whether the unit of analysis was always the participant, how limbs were selected, or how observations were handled if more than one measurement was available. Those analysis details are not reported in the registry record.
What do the mean and standard deviation describe?
For a continuous outcome, the mean is the arithmetic average on the recorded scale. The posted means are 57.24 for Glucose and 76.08 for Polidocanol With Glucose. The standard deviation describes how dispersed individual outcome values are around their group mean. The posted standard deviations are 22.69 and 18.63, respectively. A standard deviation is not the uncertainty of the mean; it describes variation among observations. The uncertainty around a group contrast is instead reflected in its standard error and confidence interval.
The outcome's registry wording is not fully clear: it is titled as change from baseline, described as a comparison of measurements in centimeters, and labeled “percent of change negative values.” A statistical calculation can compare the posted numbers, but it cannot settle what a higher value means clinically when the sign convention and scale are not fully explained. Interpretation also depends on whether measurements were made consistently and by assessors whose awareness of treatment could not influence the result. The record's masking labels conflict, and assessor procedures are not reported in the registry record.
How should the mean difference be read?
A mean difference expresses the estimated separation between two group averages in the units of the outcome. The posted mean difference is 18.84 for Polidocanol With Glucose relative to Glucose. It describes the contrast on the registry's reported scale; it is not a percentage-point difference unless the scale and calculation support that interpretation. The posted values do not establish the clinical direction of the contrast because the outcome's sign convention is unclear.
The unadjusted comparison uses the group outcome summaries without adjustment for other variables. In general, an adjusted analysis can account for prespecified baseline factors or design features and can yield a different estimate or uncertainty. The registry record does not report a detailed prespecified model or an adjusted primary estimate. The displayed recalculated comparison should therefore be understood as an unadjusted re-calculation from posted summary statistics, rather than evidence about an unreported sponsor analysis. The registry does not state whether a different sponsor analysis was conducted.
What does a p-value tell the reader?
In general, a p-value measures how surprising data at least as inconsistent with a specified null model would be if that model and its assumptions were true. The posted unadjusted p-value is <0.001. It is not the probability that the null hypothesis is true, nor does it measure the size or clinical importance of an effect. A small p-value does not address ambiguity in outcome scoring, treatment assignment descriptions, missing data, or departures from the analysis plan. Those are separate questions about study conduct and interpretation.
The p-value is described as unadjusted. The registry lists three outcome measures and two posted secondary outcomes, but does not report whether the primary analysis or other tests were selected from a larger set of analyses. The original multiplicity strategy is not reported in the registry record. If several outcomes or analyses are considered, the chance of at least one apparently unusual finding can differ from that for a single prespecified test. General methods for addressing multiple testing include prespecifying a primary outcome and applying an adjustment when appropriate, but the record does not say whether such an approach was used.
Why does dispersion matter?
General statistical interpretation of a mean comparison depends on both the estimated difference and the variability of observations. Greater dispersion makes group means less precisely estimated when other features are comparable. The standard deviations provide information about variability, while the confidence interval conveys uncertainty around the group difference. The interval is more informative about precision than the point estimate alone.
These summary statistics do not show the distribution of individual values. A mean and standard deviation can conceal skewness, outliers, or subgroups with different patterns. The registry does not report distributional diagnostics or whether the analysis accounted for any non-normality. For a continuous endpoint, the appropriateness of a mean-based method depends on the outcome distribution and model assumptions, particularly for smaller samples or strongly skewed data. No distributional assessment is reported in the registry record.
What is recalculated and what remains unknown?
The comparison statistics are labeled recalculated when they are simple unadjusted re-calculations from posted summary statistics. Such calculations provide a way to examine the reported group means, but they are not a substitute for the trial's full analysis. The record does not report individual participant data, a protocol-linked analysis plan, adjusted results, or details of how missing observations were treated. The sample-size illustrations are based on the observed effect and are planning examples, not observed power. The registry's own design assumptions are not reported in the registry record.
Finally, the treatment contrast itself needs to be clarified before the statistics can be assigned a firm treatment interpretation. The title and summary describe polidocanol versus glucose, but both arm descriptions specify the same combination and volume. Statistical methods can quantify a contrast between labeled groups; they cannot determine from those numbers which formulations the participants actually received. The methods and numerical results should therefore be read alongside this unresolved inconsistency.
10. Confidence Intervals and Precision
The reported mean difference is 18.84, and its 95% confidence interval extends from 10.58 to 27.1. A confidence interval represents the uncertainty associated with an estimate under the statistical model and its assumptions. In repeated studies using the same valid method, intervals constructed in this way would tend to cover the underlying parameter at the stated rate. It is not a statement that a particular range contains the true value with a specified probability after the data have been observed.
The interval conveys more than the point estimate alone. Its endpoints indicate a range of plausible mean differences on the recorded scale, given the analysis. Both endpoints are above zero, consistent with the reported unadjusted p-value of <0.001. The interval does not communicate whether the observed contrast is clinically important. That judgment requires knowing what the outcome's scale means, which direction is favorable, and what size of change matters. Those interpretive details are not reported in the registry record.
The width of an interval is affected by the amount of information in the data and by variability. The group standard deviations are 22.69 and 18.63, and the reported group counts are 47 and 51. These statistics help describe the data contributing to the comparison, but do not by themselves establish that the analysis is unbiased or that the observations are independent. The registry does not report the handling of missing outcomes, the precise analysis population, or whether the reported interval comes from the trial's prespecified analysis.
Precision should also be considered separately from validity and clinical meaning. A relatively narrow interval can still estimate a measure whose sign convention is unclear, and a precise difference between labeled groups does not resolve the conflicting treatment descriptions. The interval quantifies uncertainty in the numerical comparison as analyzed; it cannot correct limitations in endpoint definition, reporting, or study conduct.
11. 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.
| Effect to detect | Participants per arm, 80% power | Participants per arm, 90% power |
|---|---|---|
| 100% of the observed effect | 19 | 26 |
| 75% of the observed effect | 34 | 45 |
| 50% of the observed effect | 76 | 102 |
The planning figures are participants per arm, not total events. They illustrate the number of participants per arm associated with planning for 80% power or 90% power under the stated assumptions. The 80% column describes a planning target where a study would have an 80% chance of detecting the specified effect if that effect were real and the assumptions held. The 90% column uses a higher chance of detection under those same assumptions. These are design concepts, not guarantees about a future study's results.
The illustrations use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. The rows therefore represent planning for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. For 100% of the observed effect, the figures are 19 participants per arm for 80% power and 26 participants per arm for 90% power. For 75% of the observed effect, they are 34 participants per arm for 80% power and 45 participants per arm for 90% power. For 50% of the observed effect, they are 76 participants per arm for 80% power and 102 participants per arm for 90% power.
Smaller effects are harder to distinguish from random variation, so planning for a smaller effect requires more participants. The pattern across the rows illustrates that general principle. These values are planning illustrations computed from the observed effect, not the trial's original design calculations. The original sample-size assumptions are not reported in the registry record. This is not observed power: power is a prospective design quantity under assumptions, and calculating it after observing the results does not establish how informative or reliable the trial was.
The illustrations also assume a defined outcome and treatment contrast. The registry's endpoint wording and arm descriptions are not fully consistent, so the observed effect used in these calculations may not represent an unambiguous clinical contrast. Readers should treat the figures as conditional planning examples based on the stated statistical assumptions, rather than as evidence that the completed study was designed to detect a particular effect.
12. 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 z1−α/2 = 1.960) and the desired power (z1−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
- Observed difference Δ = 18.840; pooled standard deviation σ = 20.675.
- n = 2 × (1.96 + 0.842)2 × 20.6752 / 18.8402 = 18.9, rounded up to 19 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 <- 18.84 # observed difference in means
sigma <- 20.6751424823789 # 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(2657252)
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 = 19 (80% power), 26 (90% power)
75% of observed effect: n per arm = 34 (80% power), 45 (90% power)
50% of observed effect: n per arm = 76 (80% power), 102 (90% power)
power.t.test: 19.9
Simulated power at n = 19 per arm: 0.774 (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.
13. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary continuous outcome and two secondary outcomes: Skin Hyperpigmentation and Number of Participants With Deep Venous Thrombosis (DVT). It reports three outcome measures and two posted secondary outcomes. The primary endpoint is change from baseline in extent of telangiectasias at 2 months. The posted primary comparison has an unadjusted p-value of <0.001.
Multiplicity arises when multiple outcomes, time points, subgroups, or analytical choices are examined. In general, testing multiple hypotheses can increase the chance of at least one result appearing statistically unusual by chance. A protocol may address this by identifying a primary outcome, ordering tests, or adjusting the significance threshold. The trial's original multiplicity strategy is not reported in the registry record. It is also not reported whether there were additional planned analyses, how the secondary outcomes were analyzed, or whether adjustments were made.
The record does not provide an analysis population definition, such as whether the posted primary analysis included all randomized participants, all treated participants, or only those with outcome data. It does not report the number with missing primary outcome measurements, reasons for missingness, or methods used to handle missing data. These omissions matter because missing outcomes can affect both the estimate and its uncertainty, especially if the likelihood of missingness is related to treatment or outcome.
The record also does not describe whether participants were analyzed according to their randomized group, how treatment deviations were handled, or whether any per-protocol or sensitivity analyses were conducted. Those features are not reported in the registry record. The primary outcome groups list 47 and 51 participants, while the stated enrollment is 115; the registry does not reconcile these figures or give a participant flow account. Consequently, the relationship between enrollment and the analyzed outcome counts cannot be established from the record.
These reporting gaps do not prove that the trial lacked prespecification or appropriate methods. They mean the registry record does not allow readers to verify those methods. The result should therefore be interpreted with attention to the posted unadjusted comparison and the unresolved questions about outcome availability, analysis population, and multiplicity.
14. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Glucose | 0 | 47 | 0.0% |
| Polidocanol With Glucose | 0 | 51 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Glucose | 0 of 47 |
| Polidocanol With Glucose | 0 of 51 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Glucose | 28 of 47 |
| Polidocanol With Glucose | 21 of 51 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Glucose | Polidocanol With Glucose |
|---|---|---|---|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | 28 of 47 | 21 of 51 |
The safety figures report zero serious adverse events among 47 participants at risk in the Glucose group and zero among 51 participants at risk in the Polidocanol With Glucose group. The registry also reports zero deaths in each group. These are the posted counts; they do not establish that no serious events could occur outside the recorded follow-up or under different conditions.
For other adverse events, the record lists 28 affected participants among 47 at risk in the Glucose group and 21 affected participants among 51 at risk in the Polidocanol With Glucose group. These counts describe participants with other adverse events, not the number of separate event episodes. The record does not give the specific event terms, severity categories, timing, duration, or whether investigators considered events related to treatment. The serious-event terms list is empty.
Safety comparisons require consistent follow-up, event definitions, and reporting across groups. The arm descriptions mention assessment of adverse effects at a week and again at 2 months, but a fuller account of collection procedures and completeness is not reported in the registry record. The counts should be read as the safety information posted for these groups, not as proof of equivalence or a complete description of risk.
15. What the Result Does, and Does Not, Mean
The posted results show different average values on the registry's primary outcome scale: 57.24 for Glucose and 76.08 for Polidocanol With Glucose. The reported mean difference is 18.84, with a 95% confidence interval from 10.58 to 27.1 and an unadjusted p-value of <0.001. These figures describe a difference between the group averages on the recorded measure. The interval indicates that the estimated contrast is not highly compatible with zero under the analysis assumptions, but statistical separation is not the same as clinical importance.
The result does not by itself establish which group had more disappearance of telangiectasias. The endpoint is labeled as a percent of change with negative values, while the posted means are positive; the registry does not explain the sign convention. Nor can the contrast be confidently attributed to a distinct active treatment: the title and brief summary describe polidocanol versus glucose, but the detailed descriptions for both arms give the same mixture of 0.2% Polidocanol + 70% Glucose. The record does not resolve this discrepancy.
The results also do not establish that the difference would be similar in other populations, settings, or treatment regimens. The brief summary focuses on adult women with reticular veins on the side of the thighs and mild venous insufficiency classified as CEAP 1. The primary outcome description concerns one treated lower limb. The registry does not report enough detail about recruitment, missing outcomes, analysis populations, or outcome measurement procedures to assess all potential sources of bias or generalizability.
Zero serious adverse events and zero deaths are reported in both groups, while other adverse events are reported for 28 participants in Glucose and 21 in Polidocanol With Glucose. These counts do not establish comparative safety because the event details, causal assessments, and completeness of follow-up are not reported. Overall, the record supports a description of the posted group means and uncertainty, but leaves important questions about the treatment contrast, outcome direction, and analysis methods unresolved.
16. Why This Trial Matters Statistically
This trial is statistically informative as an example of why numerical results must be interpreted together with endpoint definitions and trial-record consistency. A mean difference and confidence interval can describe the magnitude and uncertainty of a comparison, but they cannot resolve what a scale means when its wording is unclear. Here, the endpoint is described as a change in telangiectasia extent and labeled as percent of change with negative values, yet the record does not explain the sign convention for the positive posted means.
The intervention descriptions create a separate interpretive issue. The title and brief summary frame the study as polidocanol versus glucose, while the detailed descriptions for both arms specify the same mixture. Statistical analysis can compare the outcomes attached to the arm labels, but it cannot independently verify that participants received different formulations. This illustrates why treatment definitions are part of the evidence, not merely background information.
The posted comparison also shows why statistical significance, precision, and clinical importance should be kept distinct. The p-value is <0.001 and the confidence interval is entirely above zero, but neither statistic explains whether a difference of this size matters to patients or practitioners. That assessment needs a clear measurement scale and context for meaningful change, which the record does not provide.
Finally, the planning illustrations demonstrate how assumptions shape sample-size requirements. They use fractions of the observed effect, a stated significance level, equal allocation, and a normal approximation. Such examples can inform design thinking, but they are not the trial's original justification or observed power. The record's incomplete reporting on missing outcomes, analysis populations, and multiplicity further underscores that a result's interpretation depends on transparent methods as well as calculations.
17. 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 specific to this registry record affect interpretation. The most consequential is the inconsistency in treatment descriptions. The title and brief summary present polidocanol versus glucose, and the brief summary states 0,2% polidocanol versus 75% hypertonic glucose. In contrast, the detailed descriptions for both arm labels specify 0.2% Polidocanol + 70% Glucose, with a maximum volume of 5 ml. Without clarification, the actual treatment contrast cannot be reconstructed reliably.
The primary outcome is also incompletely defined. It is described as change in extent of telangiectasias, using initial measurements in centimeters and measurements after 2 months, but is labeled “percent of change negative values.” The record does not define the calculation or the sign convention, leaving the clinical direction of higher values uncertain. It does not report measurement instrument details, assessor procedures, or a threshold for clinically meaningful change.
Masking information is inconsistent: the registry field says QUADRUPLE, while the brief summary calls the study triple-blind. The record does not identify the masked parties or describe how masking was maintained. The study is listed as randomized, but sequence generation and allocation concealment are not reported in the registry record.
The posted primary outcome groups list 47 and 51 participants, while enrollment is recorded as 115. The registry does not explain the difference, provide participant flow, or state how missing outcomes were handled. It also does not report the analysis population, the original sample-size justification, the trial's full statistical plan, or its multiplicity approach. These omissions limit evaluation of potential attrition, selection, measurement, and analysis biases. They do not establish that such problems occurred, but the available record does not permit them to be assessed fully.
18. Related Tutorials
19. Related Statistical Calculators
20. Sources
- ClinicalTrials.gov: Polidocanol Versus Glucose Treatment of Telangiectasia Trial — NCT02657252.
- Registry record last updated 2018-01-04; status last verified 2017-11.
- Results first posted 2017-11-28.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
21. Record Summary
NCT02657252 is a completed Phase 4 randomized, parallel-group trial sponsored by UPECLIN HC FM Botucatu Unesp. The registry records enrollment of 115, a start date of 2015-01, and primary completion in 2016-09. The stated population is adult women with reticular veins on the side of the thighs and mild venous insufficiency classified as CEAP 1.
The primary outcome is change from baseline in extent of telangiectasias at 2 months, summarized as a mean. The posted group means are 57.24 for Glucose and 76.08 for Polidocanol With Glucose; the reported mean difference is 18.84, with a 95% confidence interval from 10.58 to 27.1 and an unadjusted p-value of <0.001. The outcome's sign convention is not clarified. The title and summary contrast polidocanol with glucose, but the detailed descriptions for both arms list the same mixture.
The record reports zero serious adverse events and zero deaths in each group, with other adverse events affecting 28 participants in Glucose and 21 in Polidocanol With Glucose. Original design assumptions, missing-data handling, analysis populations, and multiplicity methods are not reported in the registry record.