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 Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (NCT01853384), a randomized phase 3 study. The primary outcome is Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01853384 |
| Phase | Phase 3 |
| Condition | Venous Ulcer, Venous Stasis Ulcer, Ulcer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 252 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Healthpoint |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes people with venous leg ulcers. The primary analysis population is identified as subjects who received at least one dose of test article, which the record calls the ITT population. Enrollment is recorded as 252. The brief summary had described a study expected to include at least 440 subjects; the registry does not explain the difference between that expectation and the recorded enrollment.
Intervention
The experimental group received HP802-247 with compression therapy. HP802-247 is described as fibrinogen and thrombin solutions containing living, irradiated, growth-arrested keratinocytes and fibroblasts. The description specifies application every 14 days, with vehicle used on alternate weeks.
Comparator
The comparison group received HP802-247 vehicle with compression therapy. The vehicle is described as the same solutions without cells and was given weekly. Both groups therefore received compression therapy, while the assigned study product differed.
Primary question
The primary question was whether the treatment groups differed in the number of participants achieving complete wound closure during the 12-week treatment period from baseline. Wound area was assessed weekly, and closure required confirmation over four weekly visits. The registry record does not provide a single primary comparison or a numerical estimate of the between-group effect.
3. Trial Design
This was a randomized, quadruple-masked, parallel-group Phase 3 trial sponsored by Healthpoint. The registry lists the condition as venous ulcer and related terms, and records the study as terminated. The start is recorded as 2013-11 and primary completion as 2014-12. The registry does not report why the trial was terminated.
Participants were assigned to HP802-247 plus compression therapy or HP802-247 vehicle plus compression therapy. In the HP802-247 group, the study product was administered every 14 days, with vehicle on alternate weeks. In the vehicle group, vehicle was administered weekly. Both groups received compression therapy. The vehicle is described as containing the solutions without cells.
The registry record lists enrollment as 252. Its brief summary had described an expectation of at least 440 subjects and a study across approximately 5 countries and approximately 50 sites in the European Union. The record does not explain the relationship between the expected and recorded enrollment, nor does it give a reason for the difference.
The primary endpoint concerned the number of participants with complete wound closure over the 12-week treatment period. The record describes weekly wound-area measurement and confirmation visits after initial closure. It also lists secondary outcomes concerning time to closure, closure proportions, durable healing, and pain associated with the target wound or leg. The registry does not report the detailed allocation procedure, masking procedures, or a full protocol description beyond the information stated above.
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: Subjects entered a 2-week run-in; subjects whose wound radius decreased by \< 0.349 cm/2weeks and met all other inclusion/exclusion (I/E) criteria were eligible for randomization. After completion of the treatment period, subjects entered a three-month follow up period.
Randomized
| Stage | HP802-247 Plus Compression Therapy | HP802-247 Vehicle Plus Compression Therapy |
|---|---|---|
| STARTED | 131 | 121 |
| COMPLETED | 69 | 75 |
| NOT COMPLETED | 62 | 46 |
Reasons for not completing this period:
| Reason | HP802-247 Plus Compression Therapy | HP802-247 Vehicle Plus Compression Therapy |
|---|---|---|
| Adverse Event | 5 | 3 |
| Death | 1 | 2 |
| Lost to Follow-up | 1 | 1 |
| Withdrawal by Subject | 5 | 3 |
| Sponsor Decision | 47 | 34 |
| Other | 3 | 3 |
Enrolled in Follow up Period
| Stage | HP802-247 Plus Compression Therapy | HP802-247 Vehicle Plus Compression Therapy |
|---|---|---|
| STARTED | 96 | 94 |
| Not Enrolled in Follow-up | 35 | 27 |
| COMPLETED | 96 | 94 |
| NOT COMPLETED | 0 | 0 |
Completed Follow up Visit 1
| Stage | HP802-247 Plus Compression Therapy | HP802-247 Vehicle Plus Compression Therapy |
|---|---|---|
| STARTED | 96 | 94 |
| COMPLETED | 82 | 85 |
| NOT COMPLETED | 14 | 9 |
Reasons for not completing this period:
| Reason | HP802-247 Plus Compression Therapy | HP802-247 Vehicle Plus Compression Therapy |
|---|---|---|
| Early Termination | 13 | 9 |
| Withdrawal by Subject | 1 | 0 |
Completed Follow up Visit 2
| Stage | HP802-247 Plus Compression Therapy | HP802-247 Vehicle Plus Compression Therapy |
|---|---|---|
| STARTED | 96 | 94 |
| COMPLETED | 93 | 91 |
| NOT COMPLETED | 3 | 3 |
Reasons for not completing this period:
| Reason | HP802-247 Plus Compression Therapy | HP802-247 Vehicle Plus Compression Therapy |
|---|---|---|
| Adverse Event | 1 | 0 |
| Withdrawal by Subject | 1 | 2 |
| Death | 1 | 0 |
| Lost to Follow-up | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: ITT Populations: Subjects who received at least one dose of test article.
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 | HP802-247 Plus Compression Therapy | HP802-247 Vehicle Plus Compression Therapy | Total |
|---|---|---|---|---|
| Participants analysed | 131 | 121 | 252 | |
| Age, Continuous | years | 65.6 (28 to 90) | 68.1 (28 to 92) | 66.8 (28 to 92) |
| Age, Customized: 18-39 years | participants | 6 | 3 | 9 |
| Age, Customized: 40-49 years | participants | 6 | 3 | 9 |
| Age, Customized: 50-59 years | participants | 26 | 20 | 46 |
| Age, Customized: 60-69 years | participants | 40 | 40 | 80 |
| Age, Customized: 70+ years | participants | 53 | 55 | 108 |
| Sex: Female, Male: Female | Participants | 76 | 63 | 139 |
| Sex: Female, Male: Male | Participants | 55 | 58 | 113 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 129 | 120 | 249 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 131 | 121 | 252 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline, measured over Weekly, over 12 Weeks or until wound closure, which ever occurred first.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with complete wound closure during the 12-week treatment period from baseline. Wound area was measured weekly, up to 12 weeks or until closure, using a laser-based imaging system and software to measure area. After an initial closure, participants returned for four weekly visits to confirm that the wound remained closed. A wound that opened at any of those visits was not classified as a confirmed closure.
Counting participants with an event gives a clinically interpretable summary of how many people met the closure definition during the stated follow-up. It differs from measuring the amount of wound-area change: the endpoint is based on whether a participant met the specified closure criterion. Other listed outcomes address time to closure, closure at different points during follow-up, durability of healing, and pain. These outcomes capture related but distinct aspects of the treatment experience, so they should not be treated as interchangeable with the primary endpoint.
The registry’s primary outcome description also states that remaining visit values for participants who left before the end of treatment were imputed using last observation carried forward. Wound status of closed was not imputed. That distinction matters because the primary endpoint concerns confirmed closure, not simply a carried-forward wound-area value. The record does not give a single numerical primary-endpoint result or a single between-group estimate.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a randomized comparison of HP802-247 plus compression therapy against vehicle plus compression therapy, with the primary question framed around complete wound closure during the 12-week treatment period. The available record identifies the endpoint and its assessment rules, but it does not provide one consolidated primary comparison. The registry notes that the primary outcome has several categories or time points and is not reduced to one comparison. Consequently, a single treatment-effect estimate, confidence interval, or p-value for the primary question is not reported in the registry record.
There are 39 listed analyses across 7 outcome measures. That number indicates that the results are presented through multiple analyses, but it does not by itself show which result should be treated as the primary inferential result. A set of estimates across time points can describe how outcomes vary during follow-up; it does not automatically supply one overall answer to the trial’s primary question. The registry does not report the prespecified approach for selecting or combining those analyses.
The endpoint definition adds an important qualification to interpretation. Initial apparent closure was not enough: the wound had to remain closed through four weekly confirmation visits. A wound that reopened during those visits was not counted as a confirmed closure. This makes the endpoint a measure of confirmed healing under the stated rule, rather than a snapshot of wound status at a single assessment.
The analysis population is described as subjects who received at least one dose of test article. Although the registry calls this the ITT population, the record does not provide further detail about how participants were handled across all analyses. It reports that remaining visit values for participants who discontinued before treatment ended were imputed using last observation carried forward, while wound status of closed was not imputed. Such details affect how outcome data are represented, but the record does not supply enough information to assess the influence of missing observations on the treatment comparison.
Enrollment is recorded as 252, while the brief summary had described at least 440 subjects as the expected participation. The registry does not state why the recorded enrollment differs from that expectation or whether the difference affected precision. The trial status is terminated, but no reason is reported. Neither the status nor the enrollment information alone establishes what happened to the study or why it ended.
The serious-event counts are descriptive safety information and should be read separately from the wound-closure question. Serious adverse events were reported for 5 of 131 participants in the HP802-247 group and 12 of 121 in the vehicle group. Other adverse events were reported for 60 of 131 and 64 of 121, respectively. The registry record does not provide a basis for attributing a causal difference between groups.
9. Statistical Methods Explained
Randomization is a design method intended to make treatment groups comparable, on average, with respect to characteristics that could affect outcomes. It supports a between-group comparison, but it does not guarantee that the groups are identical in a particular trial. The registry identifies the trial as randomized, quadruple-masked, and parallel-group. It does not report the allocation sequence method, the identities of the parties included in quadruple masking, or further implementation details.
What does the endpoint count?
The primary endpoint is a count of participants who met the complete-wound-closure definition during follow-up. For each group, the wound area was measured weekly, for up to 12 weeks or until closure. After initial closure, four weekly visits were used to confirm that closure persisted. Any reopening during those visits meant that the wound was not classified as a confirmed closure. Thus, the endpoint combines the occurrence of apparent closure with a confirmation requirement.
A count of participants with an event is a binary-outcome summary at the participant level: each participant is classified according to whether the defined event occurred. The registry lists the primary outcome as the number of subjects with complete closure. It does not give one consolidated comparison of those counts, an effect estimate, or an uncertainty interval in the registry record for this analysis. The number of participants alone would not describe the precision of a treatment comparison; interpretation ordinarily also considers the estimate’s uncertainty and the analysis method.
Why do repeated assessments matter?
Weekly assessment means that outcome information was collected at multiple points during follow-up. The record also lists outcomes concerning time to closure and closure at different points. Repeated measurements can describe the course of an outcome, but they raise analytical questions: which time point is primary, whether the observations are treated as related within a participant, and how results across times are interpreted together. The registry record does not report the statistical plan addressing those questions. Because the primary outcome is not reduced to a single comparison, a reader should not select one time-specific result as the overall primary finding without a stated basis.
Time to closure is a different kind of outcome from the number of participants with confirmed closure. It concerns when closure occurs, rather than only whether the event occurred during the treatment period. The listed secondary outcomes include time in days to closure and median time to closure. The registry does not provide a single summary of those results in the registry record for this analysis, nor does it describe the analysis method for handling participants without observed closure.
How should missing observations be understood?
The record says that participants who left before the end of treatment had remaining visit values imputed using last observation carried forward, abbreviated LOCF in the registry description. In general, this approach uses the last recorded value as a substitute for later missing values. It can make an analysis possible when later observations are absent, but it relies on an assumption that carrying the earlier observation forward is an acceptable representation of what would otherwise have been observed. That assumption may be uncertain when a clinical outcome changes over time.
The registry makes a separate statement that wound status of closed was not imputed. This distinction is important: carrying forward an area measurement does not mean that a participant was classified as having confirmed closure. The record does not explain how missing confirmation visits were otherwise handled, or whether alternative missing-data analyses were conducted. Those details are not reported in the registry record.
What can planning calculations establish?
The sample-size assumptions describe planning illustrations based on an observed effect, rather than the trial’s own design justification. They use a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation; the effect to detect is expressed as a fraction of the observed effect. Such calculations illustrate how a hypothetical future study’s size can depend on the effect assumed for planning. They do not describe observed power, establish the probability that the trial detected an effect, or explain the original enrollment target. The registry record does not report the trial’s sample-size justification.
More generally, a confidence interval describes a range of effect values compatible with the data and the analysis assumptions. Wider intervals indicate less precision than narrower intervals. A p-value measures how unusual the observed data would be under a specified null model and assumptions; it is not a measure of clinical importance or the probability that the null hypothesis is true. No consolidated primary estimate, confidence interval, or p-value is reported in the registry record for interpretation.
What does multiplicity mean?
Multiplicity arises when several outcomes, time points, or comparisons are examined. With more opportunities to identify a result, the chance of at least one apparently notable finding can increase if no adjustment or prespecified testing strategy is used. A statistical plan can address this through a defined hierarchy or another method, but the registry record does not report such a plan. The listed 39 analyses and 7 outcome measures make it especially important not to treat a selected result as definitive without knowing the prespecified analysis strategy. The record does not report whether multiplicity adjustments or interim analyses were used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 7 outcome measures and 39 analyses. The primary outcome is described as having several categories or time points and is not reduced to one comparison. This makes it difficult to identify a single overall primary result from the information in the record. The registry does not report a detailed statistical analysis plan that would establish a hierarchy among analyses, define a multiplicity adjustment, or explain how repeated time points were combined or interpreted.
Multiplicity is a general concern when more than one outcome, time point, or comparison is evaluated. Without a prespecified strategy, selective emphasis on one result can make the evidence appear stronger than an overall assessment would support. The record does not report whether multiplicity was controlled or whether interim analyses were conducted. Neither should be assumed to have occurred or not occurred.
The primary outcome description states that remaining visit values for participants who discontinued before treatment ended were imputed using last observation carried forward, while wound status of closed was not imputed. The record does not describe other missing-data methods, the amount of missing outcome information, or sensitivity analyses testing alternative assumptions. It also does not give a detailed account of participant inclusion for each analysis. The population is described as subjects who received at least one dose of test article, and is called the ITT population in the record; the term alone does not resolve how every analysis handled deviations or missing data.
11. 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 |
|---|---|---|---|
| HP802-247 Plus Compression Therapy | 5 | 131 | 3.8% |
| HP802-247 Vehicle Plus Compression Therapy | 12 | 121 | 9.9% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| HP802-247 Plus Compression Therapy | 60 of 131 |
| HP802-247 Vehicle Plus Compression Therapy | 64 of 121 |
Most frequent serious adverse event terms
| Event term | Organ system | HP802-247 Plus Compression Therapy | HP802-247 Vehicle Plus Compression Therapy |
|---|---|---|---|
| Multiple injuries | Injury, poisoning and procedural complications | 0 of 131 | 2 of 121 |
| Angina pectoris | Cardiac disorders | 0 of 131 | 1 of 121 |
| Arrhythmia | Cardiac disorders | 1 of 131 | 0 of 121 |
| Cardiac arrest | Cardiac disorders | 1 of 131 | 0 of 121 |
| Cardiac failure | Cardiac disorders | 0 of 131 | 1 of 121 |
| Small intestinal obstruction | Gastrointestinal disorders | 0 of 131 | 1 of 121 |
| Oedema peripheral | General disorders | 0 of 131 | 1 of 121 |
| Erysipelas | Infections and infestations | 0 of 131 | 1 of 121 |
| Gangrene | Infections and infestations | 1 of 131 | 0 of 121 |
| Pneumonia | Infections and infestations | 0 of 131 | 1 of 121 |
Most frequent non-serious adverse event terms
| Event term | Organ system | HP802-247 Plus Compression Therapy | HP802-247 Vehicle Plus Compression Therapy |
|---|---|---|---|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | 30 of 131 | 39 of 121 |
| Skin ulcer | Skin and subcutaneous tissue disorders | 17 of 131 | 20 of 121 |
| Infections and infestations | Infections and infestations | 15 of 131 | 19 of 121 |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | 18 of 131 | 13 of 121 |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | 9 of 131 | 14 of 121 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 5 of 131 | 12 of 121 |
| Excoriation | Injury, poisoning and procedural complications | 10 of 131 | 6 of 121 |
| Vascular disorders | Vascular disorders | 5 of 131 | 10 of 121 |
| General disorders and administration site conditions | General disorders | 3 of 131 | 9 of 121 |
| Infected skin ulcer | Infections and infestations | 7 of 131 | 5 of 121 |
Serious events with the highest arm-level rate: multiple injuries (1.7%), angina pectoris (0.8%), cardiac failure (0.8%), small intestinal obstruction (0.8%), oedema peripheral (0.8%).
For serious adverse events, the registry reports 5 affected participants among 131 at risk in the HP802-247 plus compression group and 12 among 121 at risk in the vehicle plus compression group. For other adverse events, it reports 60 among 131 and 64 among 121, respectively. These are counts of participants reported with events, not measures of wound closure or treatment efficacy.
The registry also lists multiple injuries at 1.7%, and angina pectoris, cardiac failure, small intestinal obstruction, oedema peripheral, and erysipelas at 0.8% each among the top serious-event terms. The record does not clarify the arm attribution for those listed percentages in the information available for this interpretation. Death counts are not reported in the registry record.
These figures describe reported events in this trial; they do not, on their own, establish that treatment caused an event or explain differences between groups. The registry record does not provide further context about event definitions, timing, severity beyond the serious-event classification, or the statistical analysis of safety outcomes. Counts should therefore be read as descriptive rather than as a causal comparison.
12. What the Result Does, and Does Not, Mean
The record establishes the trial’s intended comparison and describes how complete wound closure was assessed. It also gives enrollment, study status, and selected adverse-event counts. Those details help define what the study set out to examine and how its primary outcome was operationalized.
The information does not establish whether HP802-247 increased or decreased complete wound closure relative to vehicle. The primary result is not reported as a single comparison, and no consolidated effect estimate, confidence interval, or p-value is available in the registry record. Without those results, the size and precision of any between-group difference cannot be described. The listed number of analyses does not substitute for a clearly identified primary estimate.
The closure definition requires confirmation over four weekly visits after initial closure. This means that the endpoint represents confirmed closure under the registry’s rule, not simply an initial observation of a closed wound. The weekly assessment schedule and the secondary outcomes concerning time to closure, durable healing, and pain address different features of the outcome and should not be conflated.
The registry reports serious and other adverse-event counts, but these counts alone do not show that either study product caused an event or establish a comparative safety effect. The registry does not report deaths in the available record. Likewise, the terminated status and the difference between recorded enrollment and the expected enrollment described in the brief summary do not explain why the trial ended or what effect that had on its results.
Accordingly, the evidence described by the registry is incomplete for drawing a statistical conclusion about the primary treatment comparison. The record supports a description of trial design, endpoint rules, analysis-population wording, and selected event counts; it does not support a conclusion about treatment benefit, lack of benefit, or a definitive safety difference.
13. Why This Trial Matters Statistically
This trial raises several statistical issues that are common in clinical research. Its primary endpoint is a participant-level event with a specific confirmation rule, assessed in the context of repeated weekly measurements. Knowing how an event is defined is essential: initial wound closure and confirmed closure are not equivalent under the registry’s criteria.
The record also illustrates why results need to be interpreted alongside their analysis plan. There are multiple outcomes and analyses, while the primary outcome is not reduced to one comparison. Without a reported hierarchy or multiplicity strategy, it is not possible to establish which result should carry the greatest inferential weight. Reporting a clear primary estimate with its precision would help readers distinguish the central comparison from secondary or time-specific analyses.
Missing-data handling matters because the endpoint is followed over time and includes confirmation visits. The stated use of last observation carried forward for remaining visit values, coupled with the decision not to impute wound status as closed, shows that different outcome components were treated differently. The record does not provide enough detail to judge the consequences of missing observations or the robustness of conclusions to alternative assumptions.
Finally, the registry records enrollment of 252, although its brief summary had described at least 440 expected participants, and marks the study as terminated. These registry entries make transparent reporting of the reasons for termination, the final analysis plan, and complete outcome results particularly important for understanding the evidence. Those explanations are not reported in the registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record does not report a single consolidated primary comparison, nor does it provide the corresponding effect estimate and precision in the information available for this analysis. The primary outcome is described across several categories or time points, which limits interpretation of an overall treatment effect. The number of analyses and outcome measures is stated, but the record does not report a prespecified hierarchy or multiplicity procedure.
The population is described as subjects who received at least one dose of test article and is called the ITT population. The record does not give further details about analysis-specific inclusion, protocol deviations, or participant flow. It also does not report how many participants had missing observations, how missing confirmation visits were handled, or whether sensitivity analyses were conducted. The stated LOCF procedure applies to remaining visit values; closed wound status was not imputed.
The registry records enrollment as 252, whereas the brief summary had described at least 440 subjects as expected. It does not explain this difference or its implications. The trial is marked terminated, but the reason is not reported. The record also does not report the trial’s sample-size justification, detailed statistical analysis plan, interim analyses, or any multiplicity adjustment.
For safety, the record provides participant counts for serious and other adverse events and a list of serious-event terms with percentages, but the available description does not establish causal attribution. Death counts are not reported in the registry record. These limitations restrict what can be concluded from the recorded information and prevent a complete assessment of efficacy, precision, missing-data sensitivity, and comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers — NCT01853384.
- Registry record last updated 2016-10-03; status last verified 2016-09.
- Results first posted 2016-10-03.
- 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.
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18. Record Summary
The registry describes a randomized, quadruple-masked, parallel-group Phase 3 trial of HP802-247 plus compression therapy versus vehicle plus compression therapy for venous leg ulcers. Enrollment is recorded as 252, and the trial status is terminated. The primary endpoint was the number of participants with confirmed complete wound closure during the 12-week treatment period, with weekly wound assessment and confirmation over four weekly visits after initial closure.
The record lists 7 outcome measures and 39 analyses but does not reduce the primary outcome to one comparison. It describes LOCF for remaining visit values among participants who discontinued, while wound status of closed was not imputed. Serious adverse events were reported for 5 of 131 participants in the HP802-247 group and 12 of 121 in the vehicle group; other adverse events were reported for 60 of 131 and 64 of 121. The registry does not report a consolidated primary treatment effect, the reason for termination, or the trial’s detailed statistical plan.