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 Healing Rate of Leg Wounds Treated With Contact and Noncontact Ultrasound: The VIP Ultrasound Protocol (NCT02045303), a na na study. The primary outcome is Total Wound Area.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02045303 |
| Phase | NA |
| Condition | Chronic Ulcer of Lower Extremity |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Texas Health Resources |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with chronic or sub-acute lower extremity ulcers of various causes that required selective debridement. The condition listed in the registry record is chronic ulcer of the lower extremity. The record does not describe further eligibility details or report participant characteristics.
Intervention
The protocol combined contact ultrasound therapy with noncontact ultrasound therapy. The registry description says contact ultrasound was followed by noncontact ultrasound, with care delivered through an ambulatory wound clinic. It does not give detailed treatment schedules or doses.
Comparator
There was no concurrent control group in the registered design: the model is single group, and allocation is listed as NA. The registry summary discusses comparison with either Sonoca-180 or MIST Therapy alone as a rationale, but the design information does not identify either as a study arm.
Primary question
The primary outcome was total wound area, measured at the initial visit on day 1 and again at the subject’s last visit, up to 12 weeks or sooner if the wound closed. The registry does not report the numerical measurements or an estimate of change. Thus, the registered question concerns wound-area progress during the combined protocol, but the record does not establish how large that change was or whether it differed from what would have occurred without the protocol.
3. Trial Design
The VIP Ultrasound Protocol is registered as a completed, single-group study sponsored by Texas Health Resources. The listed enrollment is 11. The registry gives a start date of 2014-02 and a primary completion date of 2015-08. Phase is listed as NA. Allocation is also listed as NA, and masking is listed as none.
The intervention description includes contact ultrasound therapy and noncontact ultrasound therapy. The ambulatory wound clinic arm description states that both were used according to the study protocol for subjects receiving wound-clinic care. The brief summary describes contact ultrasound followed by noncontact ultrasound. The registry does not describe a randomized assignment or a concurrent control arm. Its design therefore does not support a like-for-like comparison between the combined protocol and ultrasound alone.
The primary outcome was total wound area. It was to be measured at the initial assessment on day 1 and at the subject’s last visit, which could occur at 12 weeks or sooner if the wound closed. Wound area was defined as length multiplied by width. Secondary outcomes listed are total wound volume and reductions in wounds with slough or eschar at visit 2 and at the last visit.
The registry lists 4 outcome measures, while the analysis count is 0. It does not report the statistical analysis plan, the approach to follow-up measurements, or the way missing observations were handled. The completed status indicates the trial’s registry status, but it does not supply numerical results for the primary endpoint.
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: The wound care doctor wrote orders for ultrasound therapy performed by Physical Therapist (PT). Throughout the open enrollment phase, the PT screened referred patients to check if they met study criteria.
Overall Study
| Stage | Ambulatory Wound Clinic - Wound Age Between 4 and 21 Weeks | Ambulatory Wound Clinic - Wound Age Between 22 and 46 Weeks | Ambulatory Wound Clinic - Wound Age >= 47 Weeks |
|---|---|---|---|
| STARTED | 6 | 3 | 2 |
| COMPLETED | 4 | 0 | 2 |
| NOT COMPLETED | 2 | 3 | 0 |
Reasons for not completing this period:
| Reason | Ambulatory Wound Clinic - Wound Age Between 4 and 21 Weeks | Ambulatory Wound Clinic - Wound Age Between 22 and 46 Weeks | Ambulatory Wound Clinic - Wound Age >= 47 Weeks |
|---|---|---|---|
| Protocol Violation | 2 | 1 | 0 |
| Withdrawal by Subject | 0 | 2 | 0 |
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 | Wound Age Between 4 and 21 Weeks | Wound Age >=47 Weeks | Total |
|---|---|---|---|---|
| Participants analysed | 4 | 2 | 6 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 | 2 | 4 |
| Age, Categorical: >=65 years | Participants | 2 | 0 | 2 |
| Sex: Female, Male: Female | Participants | 1 | 1 | 2 |
| Sex: Female, Male: Male | Participants | 3 | 1 | 4 |
| Race/Ethnicity, Customized: Asian | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Black | Participants | 1 | 1 | 2 |
| Race/Ethnicity, Customized: Hispanic or Latino | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: White | Participants | 3 | 1 | 4 |
| Wound Location: Ankle | Wounds | 0 | 1 | 1 |
| Wound Location: Foot/Heel/Toes | Wounds | 3 | 2 | 5 |
| Wound Location: Knee | Wounds | 0 | 1 | 1 |
| Wound Location: Lower Leg | Wounds | 1 | 4 | 5 |
| Initial Wound Area | cm^2 | 10.12 (1.92 to 15.36) | 7.93125 (1.02 to 18.6) | 8.66083 (1.02 to 18.6) |
| Associated Diagnosis: S/p Ganglion Cyst Removal | Wounds | 1 | 0 | 1 |
| Associated Diagnosis: Stage IV Pressure Ulcer | Wounds | 1 | 0 | 1 |
| Associated Diagnosis: Diabetes | Wounds | 2 | 3 | 5 |
| Associated Diagnosis: Peripheral Artery Disease | Wounds | 2 | 0 | 2 |
| Associated Diagnosis: Above Knee Amputation (opposite limb) | Wounds | 1 | 0 | 1 |
| Associated Diagnosis: Post-Surgical Debridement | Wounds | 1 | 0 | 1 |
| Associated Diagnosis: Vasculitis | Wounds | 0 | 3 | 3 |
| Associated Diagnosis: Cat Bite | Wounds | 1 | 0 | 1 |
| Associated Diagnosis: 3rd Degree Burn | Wounds | 0 | 5 | 5 |
| Associated Diagnosis: Venous Insufficiency | Wounds | 0 | 5 | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Total Wound Area, measured over Initial measurement at day 1 and measurement at the subject's last visit at 12 weeks or sooner if the wound closed before then..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Squared centimiters |
| Endpoint classification | Continuous Endpoint |
Total wound area is the primary endpoint. The registry defines the measurement as wound length multiplied by width and describes reporting the group mean and standard deviation at the initial measurement on day 1 and the last treatment day. The last measurement was scheduled for up to 12 weeks, or earlier if the wound closed. The listed unit is squared centimiters.
Area is used as a measurable description of wound size and is intended in this protocol to assess progress towards closure. A change in area over follow-up can describe how the measured wounds changed while participants received care. However, the registry record does not give the mean values, standard deviations, or a numerical change. It also does not report a statistical estimate or uncertainty interval for change.
As a general statistical point, a group mean gives a summary of the measured areas, while a standard deviation describes how spread out individual measurements are around that mean. The standard deviation is not itself a measure of uncertainty in the group mean. The registry’s endpoint description does not say how any change between the initial and last measurements was calculated or tested.
Because the design is single group, a change over time would describe the course observed among participants in the protocol, not a treatment effect relative to a concurrent control. Natural healing, other wound care, and differences among wounds could also contribute to change. The registry does not report numerical endpoint results with which to assess the direction, size, or precision of the observed course.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically interpretable measurement—total wound area at the initial assessment and at the last visit—but does not report the resulting values. No numerical mean, standard deviation, change estimate, confidence interval, or test result for the primary outcome is included in the record. Consequently, the size and precision of any change cannot be assessed from these registry entries.
The design is important to interpretation. This was a single-group study, with allocation listed as NA and no masking. The registry does not identify a concurrent comparison group. A before-and-after measurement can describe what happened to wounds during follow-up, but it cannot separate changes associated with the intervention from changes due to the natural course of wounds, other care, or time. The study summary states a belief about healing rate after contact ultrasound followed by noncontact ultrasound, and mentions comparison with either Sonoca-180 or MIST Therapy alone. That statement is the registry’s rationale, not a comparative result from a registered control arm.
The enrolled number is 11, but the registry entries do not state how many participants contributed measurements at both time points or how many wounds were assessed for the primary outcome. The endpoint permits a last visit before 12 weeks if a wound closed. Without participant-level follow-up information and a stated analysis approach, the effect of differing observation times and incomplete measurements is not assessable.
In general, a confidence interval communicates the range of effect sizes compatible with the data and the analysis assumptions. A narrow interval indicates greater precision than a wide interval; it does not by itself resolve biases from a non-comparative design. No interval is reported in the registry record. Similarly, no primary-outcome p-value is reported, so there is no basis for describing statistical significance.
The secondary outcomes include total wound volume and slough/eschar reduction at specified visits. Their presence broadens what the protocol intended to observe, but no numerical values or statistical analyses for them are reported in the registry record. The registry lists 4 outcome measures and 0 analyses. The available information therefore describes the question and measurements, not an estimate of efficacy. It should not be read as evidence that the combined protocol did or did not improve healing.
9. Statistical Methods Explained
The statistical methods documented in the registry record are limited. The primary endpoint is a continuous measure, total wound area, and the planned descriptive summaries are the mean and standard deviation. The record specifies an initial measurement on day 1 and a last-visit measurement at 12 weeks or earlier if the wound closed. It does not describe a formal hypothesis test, a model, an adjustment strategy, or an uncertainty interval.
What do the mean and standard deviation describe?
As a general statistical explanation, the mean is a measure of the central value of a set of observations. The standard deviation describes the spread of those observations around their mean. A standard deviation reflects variation among measured wounds or participants; it is not the same as the uncertainty around the mean. That uncertainty depends on features of the data and the analysis, which are not reported for this trial.
The registry says that wound area was measured as length multiplied by width. This defines the recorded area, but the record does not give details such as measurement reliability, assessor procedures, or whether the same assessor made repeated measurements. It also does not report whether the primary analysis used each participant’s change, compared group summaries across visits, or applied another method. Those distinctions matter because paired observations from the same people are related, and analyses should account for that relationship when estimating change.
What can repeated measurements establish?
In general, measuring an outcome at baseline and follow-up can show how the recorded outcome changes over time in the observed group. A within-group change is not equivalent to a randomized treatment comparison. Without a concurrent control group, the change cannot isolate the contribution of treatment from other explanations, including the natural course of the condition, accompanying care, or changes in who remains under observation.
The protocol allowed the last measurement at 12 weeks or sooner if a wound closed. This means the last-visit timing could vary. In general, the timing and reason for a missing or early measurement can affect interpretation. The registry record does not say how early closure was represented in the analysis, how measurements were handled when a participant did not return, or whether all enrolled participants were included in the primary analysis.
How should uncertainty be understood?
In general, a confidence interval expresses uncertainty around an estimated quantity under the model and assumptions used. It gives a range of values that are reasonably compatible with the data and method; it does not show that the whole range is equally likely, and it cannot remove design limitations. A p-value, when reported, describes how unusual the data would be under a specified null hypothesis and analysis assumptions. Neither a p-value nor a confidence interval is reported for the primary outcome in the registry record.
The registry includes sample-size assumptions for planning illustrations: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect set as a stated fraction of the observed effect. Those assumptions are explicitly described as planning illustrations, not the trial’s own design. The study itself is registered as single group, and no calculated planning values are included in the registry record. Such illustrations are not observed power and do not establish that the study was designed or analyzed as a two-arm trial.
What remains unknown about the analysis?
The registry lists 0 analyses. It does not report whether an analysis was adjusted for baseline characteristics, how any outliers were treated, whether a distributional assumption was checked, or how uncertainty was calculated. The record also does not provide an analysis population definition. These omissions prevent a detailed appraisal of the statistical implementation. They should not be filled in by assuming customary methods: the registry does not report them.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 4 outcome measures. The primary outcome is total wound area; listed secondary outcomes include total wound volume and slough/eschar reduction at visit 2 and at the last visit. The record does not describe a multiplicity strategy, such as prioritizing a family of tests or adjusting inference when examining several outcomes. It also does not report statistical tests for these outcomes. Therefore, the chance of false-positive findings across multiple analyses cannot be evaluated from the registry record.
Missing-data handling is not reported in the registry record. The primary measurement could occur at the last visit up to 12 weeks, or sooner if the wound closed, but the record does not explain how participants with no final measurement were handled. It does not report whether all enrolled participants were included, whether observations were excluded, or whether any imputation or sensitivity analysis was used.
The analysis populations are also not reported in the registry record. In general, a clear analysis population definition helps readers understand who contributed data and whether the analysis follows the intended study group. The registry lists enrollment of 11 but does not state the number with usable baseline and follow-up measurements for each outcome. The analysis count is 0. Without these details, the effects of missing follow-up, exclusions, and multiple outcome assessments remain unknown.
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 |
|---|---|---|---|
| Wound Age Between 4 and 21 Weeks | 0 | 4 | 0.0% |
| Wound Age >=47 Weeks | 0 | 2 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Wound Age Between 4 and 21 Weeks | 0 of 4 |
| Wound Age >=47 Weeks | 0 of 2 |
The registry lists serious adverse event figures in two wound-age groups: “Wound Age Between 4 and 21 Weeks” and “Wound Age >=47 Weeks.” In the first group, 4 were listed as at risk and 0 as affected for serious events; 4 were listed as at risk and 0 as affected for other events. In the second group, 2 were listed as at risk and 0 as affected for serious events; 2 were listed as at risk and 0 as affected for other events.
These entries mean that no affected events are recorded in the displayed group fields. They do not establish that no adverse events occurred in every participant or outside the listed reporting categories. The registry record does not report death counts, and no serious-event terms are listed. The record also does not explain how the wound-age groups relate to the primary analysis population or provide further safety follow-up detail.
In general, zero events in a registry entry should be read with its denominator, reporting definitions, and follow-up context in mind. The listed at-risk counts are limited group figures, not a complete account of all safety information. These sparse entries do not, by themselves, establish the absence of risk.
12. What the Result Does, and Does Not, Mean
The registry record describes a protocol that used contact ultrasound followed by noncontact ultrasound for lower extremity ulcers, with total wound area as the primary outcome. It identifies the intended measurement times and the study’s single-group structure. These details clarify what the investigators intended to observe.
The record does not report primary outcome values or statistical analyses. It therefore does not show how wound area changed, how variable the measurements were, or how precise an estimate of change might be. The stated summary that healing rate is higher with the combined approach is a description of the study’s premise, not a numerical result in the registry record recorded.
Even if a within-group reduction in area were reported, it would describe change during the observed care period rather than establish that the intervention caused the change. Without a concurrent comparator, differences attributable to time, other care, or participant and wound characteristics cannot be separated from the intervention. The registry’s mention of comparisons with individual ultrasound therapies does not make those therapies study arms in the registered single-group design.
In general, statistical significance and clinical meaning are different questions. A statistical test concerns compatibility with a specified null hypothesis under its assumptions; clinical interpretation concerns the size and relevance of the change in context. Neither can be assessed for the primary endpoint from the numerical information in this record, because those results are not reported.
The appropriate reading is therefore bounded: the registry documents the planned combined intervention and wound-area endpoint, but the registry entries do not support a conclusion about the magnitude, precision, or causal effect of the protocol. Nor do the sparse adverse-event entries establish that the intervention is free of risk.
13. Why This Trial Matters Statistically
This trial is statistically notable because its registry rationale describes comparison with ultrasound approaches used alone, while the registered model is single group and allocation is NA. That distinction is central: a within-group follow-up can describe change, but it cannot provide the direct comparative estimate implied by a control-based question. Readers need the design information as well as the intervention description to understand what conclusions the data could support.
The primary endpoint is a repeated measurement of wound area, defined as length multiplied by width. The initial measurement and last-visit measurement create a natural opportunity to describe change over time. At the same time, the last assessment could occur at 12 weeks or earlier if the wound closed, so timing and outcome availability are relevant to interpretation. The registry does not explain how these features were handled statistically.
The record also illustrates the difference between specifying an outcome and reporting evidence about it. It identifies total wound area and secondary measures, but lists 0 analyses and gives no numerical primary outcome results in the registry record. Without estimates and uncertainty, readers cannot judge the size or precision of observed changes. Without a comparator, any observed change would still require cautious interpretation as an association over time rather than a causal treatment contrast.
Finally, the safety entries show why event counts need context: the record provides small at-risk group counts and zero affected entries, but does not report death counts or detailed follow-up. Taken together, the design and reporting make this record useful for understanding the intended question and measurement plan, while leaving the treatment effect and its uncertainty unresolved.
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 most important limitation for interpretation is the single-group design. Allocation is listed as NA, and the registry does not identify a concurrent control group. Consequently, the design cannot isolate the effect of the combined ultrasound protocol from the natural course of wounds or other care. The registry summary’s assertion about healing rate and its mention of therapies used alone do not substitute for a control arm in the registered design.
Numerical primary outcome results are not reported in the registry record. There is no mean area at either measurement time, standard deviation, change estimate, confidence interval, or test result in the registry record. The registry lists 0 analyses, so the statistical approach cannot be evaluated.
Follow-up timing could vary because the last measurement was planned at 12 weeks or earlier if the wound closed. The record does not report how many participants had a final measurement, how early closure was handled analytically, or how missing values were treated. Participant characteristics, wound-level details, and information about measurement procedures are also not reported in the registry record.
The registry includes secondary outcome descriptions, but does not report their results or a plan for handling multiple outcomes. Safety entries are limited to the displayed wound-age groups; death counts are not reported in the registry record, and no serious-event terms are listed. These limitations prevent a complete assessment of benefit, uncertainty, and safety from the information recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Healing Rate of Leg Wounds Treated With Contact and Noncontact Ultrasound: The VIP Ultrasound Protocol — NCT02045303.
- Registry record last updated 2022-01-24; status last verified 2022-01.
- Results first posted 2022-01-24.
- 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
NCT02045303 is a completed, single-group study sponsored by Texas Health Resources, with enrollment of 11. It studied contact ultrasound therapy followed by noncontact ultrasound therapy for lower extremity ulcers. Allocation is listed as NA, masking as none, and phase as NA.
The primary outcome was total wound area, measured initially on day 1 and at the last visit up to 12 weeks or earlier if the wound closed. Secondary outcomes included wound volume and slough/eschar reduction. The registry lists 4 outcome measures and 0 analyses. Numerical primary outcome results and the statistical analysis plan are not reported in the registry record.