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 Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures (NCT01941719), a randomized na study. The primary outcome is Foot Care Behavior Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01941719 |
| Phase | NA |
| Condition | Diabetes Mellitus, Diabetic Neuropathies, Foot Complications |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 99 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Temple University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people with diabetes, with the registry listing Diabetes Mellitus, Diabetic Neuropathies, and Foot Complications as conditions. Enrollment was 99. The primary-outcome description notes that fewer participants were available at follow-up visits because of drop out.
Intervention
Enhanced Foot Care Education added a personal component to standard diabetic foot self-care instruction. At baseline, participants viewed their personal barefoot plantar pressure during gait, and the importance of daily foot self-care was reinforced.
Comparator
Standard Foot Care Education reviewed daily foot inspection and proper footwear at all times. Both study arms therefore received foot-care instruction; the distinguishing feature described for the enhanced arm was viewing personal plantar-pressure information during education.
Primary question
The study aimed to examine whether the enhanced educational strategy changed foot-care behavior compared with standard education. The primary outcome was the number of participants inspecting their feet at least daily, assessed at baseline and follow-up visits. A single between-arm outcome estimate is not reported in the registry record.
3. Trial Design
This was a randomized, parallel-group study with single masking. The registry lists the study as completed and gives enrollment as 99. The phase is listed as NA. Temple University is named as the sponsor. The recorded start date is 2008-05-02, and the primary completion date is 2011-09-07.
The two behavioral interventions were Enhanced Foot Care Education and Standard Foot Care Education. The standard arm reviewed diabetic foot self-care instructions, including daily inspection and proper footwear at all times. The enhanced arm included that standard instruction and, at baseline, reinforced daily self-care by showing participants personal barefoot plantar pressure during gait.
The primary outcome was described as a foot-care behavior score, with the measure stated in terms of participants who inspect their feet at least daily. The assessment schedule was baseline, 1, 3,6,9 and 12 months. The registry description notes that fewer participants attended follow-up visits because of drop out. Foot complications were listed as a secondary outcome.
The registry does not identify which people were masked, how randomization was generated or implemented, or whether allocation was concealed. The protocol, eligibility criteria, study setting, and details of follow-up procedures are not reported in the registry record. These omissions limit how fully the conduct of the comparison can be assessed from the record alone.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Standard Foot Care Education | Enhanced Foot Care Education |
|---|---|---|
| STARTED | 48 | 51 |
| Month 1 | 43 | 48 |
| Month 3 | 38 | 44 |
| Month 6 | 34 | 42 |
| Month 9 | 29 | 37 |
| Month 12 | 28 | 32 |
| COMPLETED | 28 | 32 |
| NOT COMPLETED | 20 | 19 |
Reasons for not completing this period:
| Reason | Standard Foot Care Education | Enhanced Foot Care Education |
|---|---|---|
| Lost to Follow-up | 20 | 19 |
Analysis population for the primary outcome, as defined in the registry: Fewer participants at follow up visits due to drop out
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 | Standard Foot Care Education | Enhanced Foot Care Education | Total |
|---|---|---|---|---|
| Participants analysed | 48 | 51 | 99 | |
| Age, Continuous | years | 53.0 (SD 9.5) | 55.9 (SD 10.2) | 54.5 (SD 10.0) |
| Sex: Female, Male: Female | Participants | 18 | 20 | 38 |
| Sex: Female, Male: Male | Participants | 30 | 31 | 61 |
| Region of Enrollment: United States | participants | 48 | 51 | 99 |
6. Primary Endpoint
The registry lists the primary outcome as Foot Care Behavior Score, measured over baseline, 1, 3,6,9 and 12 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled Foot Care Behavior Score, but the specific measure described is the number, and percentage, of participants who inspect their feet at least daily. It is a count-based behavioral measure: participants are classified according to whether they meet the daily-inspection criterion at an assessment visit. The measure is not a count of complications or a direct measure of plantar pressure.
Daily inspection is relevant to the educational objective because both arms received instruction about foot self-care, and the enhanced strategy specifically reinforced the importance of daily care. Comparing this behavior between education groups could therefore address whether the additional personalized educational component is associated with a difference in the targeted practice. That rationale does not establish that the measure captures every aspect of foot care or predicts clinical outcomes.
The registry lists assessments at baseline and at follow-up visits through 12 months. Repeated observations can describe behavior over time, but the record does not report a single primary follow-up time point or a rule for combining measurements across visits. It also does not provide outcome values by arm, an effect estimate, or an uncertainty interval. Consequently, the endpoint's intended meaning can be described, but its observed comparative result cannot be interpreted from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison of two educational approaches, but it does not report a single result for the primary foot-care behavior outcome. The outcome description concerns participants inspecting their feet at least daily and lists assessments at baseline and follow-up. The record also notes that fewer participants were available at follow-up because of drop out. Without arm-specific outcome counts at a defined visit, or a stated method for analyzing repeated assessments, there is no reported primary comparison to interpret.
Accordingly, no direction or magnitude of an effect on daily inspection can be stated from this record. A p-value, confidence interval, and estimate of the difference between groups for the primary outcome are not reported in the registry record. The absence of a reported estimate is not evidence that the groups were alike, nor does it show that one educational approach was better. It means the posted record does not provide the information needed to judge the primary comparison's size or precision.
The adverse-event entries provide descriptive counts. For Standard Foot Care Education, the registry lists 0 serious events among 48 at risk and 21 other events among 48 at risk. For Enhanced Foot Care Education, it lists 0 serious events among 51 at risk and 30 other events among 51 at risk. These entries describe events recorded in each group; they do not by themselves establish that an event was caused by an intervention. No deaths are listed in either arm. The record lists cellulitis, foot and lower limb amputation among serious-event terms, each at 0.0%.
These safety entries do not substitute for the primary behavioral results. The registry lists Foot Complications as a secondary outcome, but does not report its results in the registry record for interpretation. The record also does not provide event definitions, follow-up completeness for adverse events, or statistical comparisons for these counts. The counts should therefore be read as descriptive registry entries, not as a formal test of differences in safety or effectiveness.
9. Statistical Methods Explained
The design is described as randomized, parallel-group, and single-masked. Randomization is intended, in general, to make treatment assignment independent of participants' characteristics. If assignment is implemented adequately, it can support a fair comparison by reducing systematic differences at the start of a trial. The registry record does not report the random-sequence method, allocation concealment, or which individuals were masked. Those details matter when assessing whether assignment could have been anticipated and whether expectations might influence care or outcome assessment.
What does a count-based endpoint mean?
The primary measure is the number of participants who inspect their feet at least daily. A count is useful for describing how many people meet a defined behavioral criterion, but interpreting a comparison also requires knowing the group denominators and the visit to which the count applies. The registry describes several assessment occasions rather than identifying one result for a single follow-up visit. It does not report a method for handling the repeated measurements or an arm-by-time estimate.
For a binary outcome, a statistical analysis may compare the proportion meeting the criterion in each group or model the outcome at participant level. These are general possibilities, not methods confirmed for this study. The record does not report the statistical model, the effect measure, covariate adjustment, or the handling of within-participant correlation across visits. Thus a specific model should not be attributed to the trial.
How should uncertainty be understood?
In general, a confidence interval expresses a range of effect values compatible with the data and the method used. Its width conveys precision: wider intervals indicate greater uncertainty, while narrower intervals indicate greater precision. A p-value, in general, describes how unusual the observed data would be under a specified null hypothesis and statistical model. Neither quantity gives the probability that a treatment works. No confidence interval or p-value for the primary outcome is reported in the registry record, so neither the magnitude nor precision of the primary comparison can be assessed.
The registry record identifies a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The illustration is not the trial's own design justification or an observed-power analysis. The record does not report a sample-size justification, target effect, or protocol-level planning assumptions. Planning calculations based on an observed effect are conditional illustrations; they cannot replace a reported outcome estimate and uncertainty interval, and they should not be interpreted as evidence that the study was adequately powered.
Why does missing follow-up matter?
The primary-outcome description explicitly notes fewer participants at follow-up because of drop out. In general, missing outcome data can affect both precision and the validity of a comparison. If participants with missing observations differ systematically from those observed, a complete-case comparison may not represent the original randomized groups. The extent and consequences of missingness depend on why observations are absent and how the analysis handles them. The registry does not report visit-specific denominators, reasons for drop out, imputation, sensitivity analyses, or a missing-data assumption.
Finally, multiple assessment visits raise a general multiplicity issue. Examining several visits can create multiple opportunities to identify an apparently notable result. A prespecified primary visit, a repeated-measures model, or an adjustment for multiple comparisons are possible approaches, but the registry does not report which approach was planned or used. The outcome's several time points are not reduced to a single comparison in the record. Therefore, the primary result cannot be reconstructed or evaluated from the stated outcome description alone.
10. Multiplicity, Missing Data and Analysis Populations
The primary foot-care behavior measure is scheduled at baseline and follow-up visits, and the registry description notes that fewer participants were available at follow-up because of drop out. The record does not identify a single primary follow-up visit or explain how results across visits were combined. It also does not report whether the analysis accounted for repeated measurements on the same participant.
Multiplicity is relevant when results are examined across more than one visit or outcome. In general, testing multiple comparisons can increase the chance of finding a statistically notable result by chance. A statistical plan may address this through a prespecified primary comparison, an adjustment, or a model that uses the repeated observations. The registry does not report a multiplicity strategy, an analysis plan, or which comparisons were designated in advance.
Missing-data methods are also not reported in the registry record. The record does not give visit-specific numbers of participants with observed outcomes, reasons for missing assessments, or details of any imputation or sensitivity analysis. The analysis population is not specified, and there is no stated intention-to-treat or per-protocol analysis. Without these details, the effects of drop out on the primary comparison cannot be assessed. These are reporting gaps, not evidence that a particular method was or was not used.
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 |
|---|---|---|---|
| Standard Foot Care Education | 0 | 48 | 0.0% |
| Enhanced Foot Care Education | 0 | 51 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Standard Foot Care Education | 0 of 48 |
| Enhanced Foot Care Education | 0 of 51 |
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 |
|---|---|
| Standard Foot Care Education | 21 of 48 |
| Enhanced Foot Care Education | 30 of 51 |
Most frequent serious adverse event terms
| Event term | Organ system | Standard Foot Care Education | Enhanced Foot Care Education |
|---|---|---|---|
| cellulitis, foot | Infections and infestations | 0 of 48 | 0 of 51 |
| lower limb amputation | Infections and infestations | 0 of 48 | 0 of 51 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Standard Foot Care Education | Enhanced Foot Care Education |
|---|---|---|---|
| Hospitalization | Cardiac disorders | 8 of 48 | 12 of 51 |
| Pre-ulcerative lesion | Skin and subcutaneous tissue disorders | 7 of 48 | 11 of 51 |
| Ingrown | Skin and subcutaneous tissue disorders | 3 of 48 | 4 of 51 |
| diabetic foot ulcer | Skin and subcutaneous tissue disorders | 3 of 48 | 3 of 51 |
Serious events with the highest arm-level rate: cellulitis, foot (0.0%), lower limb amputation (0.0%).
The safety entries distinguish serious events from other events and list the number at risk and the number affected in each arm. In Standard Foot Care Education, 0 serious events are listed among 48 at risk, with 21 other events among 48 at risk. In Enhanced Foot Care Education, 0 serious events are listed among 51 at risk, with 30 other events among 51 at risk. The registry lists 0 deaths in each arm.
Foot cellulitis and lower limb amputation are listed among serious-event terms, each at 0.0%. The entries are descriptive counts in the registry record. They do not establish that an event was caused by an intervention, and the record does not provide a statistical comparison, definitions, or details about adverse-event ascertainment and follow-up. The other-event counts should not be interpreted as counts of serious events. These safety data also do not provide the missing primary foot-care behavior results.
12. What the Result Does, and Does Not, Mean
The study asks a focused educational question: whether adding a view of personal plantar-pressure information to standard diabetic foot instruction is associated with different foot-care behavior. The registry identifies daily foot inspection as the primary behavioral measure and describes repeated assessment through follow-up. It also identifies foot complications as a secondary outcome. These objectives make the comparison relevant to evaluating an educational strategy, but they do not establish what the results were.
The primary comparative outcome values are not reported in the registry record. There is no reported effect estimate, confidence interval, or p-value for daily inspection. As a result, the record cannot establish whether the enhanced approach was associated with more or fewer participants meeting the daily-inspection criterion, or how precise such a difference might be. No conclusion about the intervention's effectiveness can be drawn from the stated outcome description alone.
The record's adverse-event counts are descriptive and do not demonstrate a causal relationship. The zero serious-event counts and the other-event entries should be interpreted in light of the limited information about event definitions and ascertainment. Likewise, a planning illustration based on an observed effect is not an observed-power result and is not a substitute for outcome estimates with uncertainty.
In general, a randomized design can support a comparative interpretation when assignment, follow-up, outcome measurement, and analysis are adequately described. Here, key details about randomization procedures, masking, missing-data handling, and analysis methods are not reported in the registry record. The record therefore documents the study question and design features, but leaves the primary comparative finding and several important parts of its statistical interpretation unresolved.
13. Why This Trial Matters Statistically
This trial is statistically interesting because the educational contrast is specific: both groups received foot-care instruction, while the enhanced approach added a personalized view of plantar pressure during gait. The intended endpoint is also behavioral rather than a direct clinical event, counting participants who inspect their feet at least daily. This makes it important to distinguish an educational or behavioral outcome from clinical complications.
The repeated assessment schedule presents an analytical question. A behavior measured at several visits can be described visit by visit or analyzed as a trajectory, but those approaches answer different questions and may account differently for within-person dependence. The registry identifies the visit schedule but does not report the method used to handle the repeated observations or define one primary follow-up comparison. This gap prevents a clear reading of the intended estimand, meaning the precise treatment contrast the analysis sought to estimate.
Drop out is another relevant statistical feature because the record notes fewer participants at follow-up. The amount and pattern of missingness affect how precisely, and potentially how fairly, the randomized groups can be compared. Without visit-specific outcome denominators and missing-data methods, readers cannot determine how much information contributed to each follow-up result.
Finally, registry transparency matters. The record identifies a randomized parallel design and lists a planning illustration, but does not report a full statistical analysis plan or the primary outcome results. This leaves the central comparison unavailable for assessment. The statistical importance of the record is therefore partly in showing which design and reporting details are needed to evaluate an education trial, not in establishing an effect that the record does not report.
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 main trial-specific limitation in interpreting the registry record is that it does not report the primary outcome values by arm. Although daily foot inspection is described as the primary measure, the record does not provide a defined single follow-up comparison, effect estimate, or uncertainty interval. It is therefore not possible to characterize the observed difference in the central outcome from this record.
The outcome is scheduled at several visits, but the registry does not explain whether the analysis treated each visit separately or modeled change over time. The description also notes fewer participants at follow-up because of drop out, without giving visit-specific numbers or missing-data methods. These omissions make it difficult to assess the completeness and comparability of the follow-up outcome data.
Important design and analysis details are also absent. The registry does not report who was masked, how allocation was concealed, the method for generating random assignments, or the statistical model and analysis population. Eligibility criteria and the study setting are not reported in the record. The listed secondary outcome of foot complications has no reported results in the registry record for interpretation.
The safety entries are limited to counts and do not include event definitions, ascertainment procedures, or statistical comparisons. The planning illustration is based on an observed effect and should not be confused with the original design rationale or evidence of study power. These limitations concern what can be inferred from the registry record; they do not establish that unreported procedures were absent from the trial itself.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Enhancing Diabetic Foot Education by Viewing Personal Plantar Pressures — NCT01941719.
- Registry record last updated 2021-12-07; status last verified 2021-11.
- Results first posted 2021-12-07.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed randomized, parallel-group, single-masked study sponsored by Temple University, with enrollment of 99. It compared enhanced diabetic foot education, which added viewing personal barefoot plantar pressure during gait, with standard foot-care education covering daily inspection and proper footwear.
The primary measure was the number of participants who inspect their feet at least daily, assessed at baseline and follow-up visits through 12 months. The registry notes fewer participants at follow-up because of drop out. Foot complications were listed as a secondary outcome. The primary comparative results, analysis methods, and missing-data procedures are not reported in the registry record. Descriptive safety counts are listed for serious and other events, with no deaths reported in either arm.