Trial · NCT02158806
Low Dose Aspirin for Venous Leg Ulcers
NCT02158806, Phase 3, Completed, University of Auckland, New Zealand; results first posted 2019-01-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Low Dose Aspirin for Venous Leg Ulcers. Trials, record NCT02158806. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02158806
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Low Dose Aspirin for Venous Leg Ulcers
- NCT number
- NCT02158806
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 251 participants, actual
- Lead sponsor
- University of Auckland, New Zealand
- Conditions
- Venous Leg Ulcer
- Interventions
- Aspirin, Placebo
- First posted
- 2014-06-09
- Last updated
- 2019-01-04
- Results first posted
- 2019-01-04
- Limitations and caveats
- Recruitment was lower than anticipated as fewer aspirin-naive patients being available than estimated. However we had 82% power to observe the anticipated difference if assumptions had been correct.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Complete Healing of Reference Ulcer | 24 weeks | Time to event (complete healing defined as intact skin with absence of scab) |
| Secondary | Number of Participants With Healed Venous Leg Ulcers | 24 weeks | Number of participants in each arm with completely healed reference ulcers at 24 weeks |
| Secondary | Change in Estimated Ulcer Area | Baseline, 24 weeks | Change in estimated ulcer area from baseline to 24 weeks |
| Secondary | Change in Health-related Quality of Life (Short Form 36) | Baseline, 24 weeks | Mean difference in change in Short Form 36 (SF36) from baseline to 24 weeks. Crude subscale scores for each group are not shown (each crude subscale is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on the subscales for that group. |
| Secondary | Change in Health-related Quality of Life (EuroQol-5D 3L) | Baseline, 24 weeks | Mean difference in change measured by EuroQol 5D (EQ5D 3L) from baseline to 24 weeks. Crude health state scores for each group are not shown (health state is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on health state for that group. |
| Secondary | Change in Health-related Quality of Life (Charing Cross Venous Ulcer Questionnaire) | 24 weeks | Mean difference in change in Charing Cross Venous Ulcer Questionnaire (CXVUQ)) from baseline to 24 weeks. Crude subscale scores for each group are not shown (each crude subscale is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on the subscales for that group. |
| Secondary | Number of Participants With Adherence to Treatment | 24 weeks | Adherence to study medication as measured by pill counts (agreement between expected number of tablets remaining after healing and days to healing) |
| Secondary | Incidence of Adverse Events at 24 Weeks | 24 weeks | Total number of different types of adverse events in participants who reported with any untoward medical event |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Complete Healing of Reference Ulcer | 24 weeks | days | MEDIAN | |
| SECONDARY | Number of Participants With Healed Venous Leg Ulcers | 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Estimated Ulcer Area | Baseline, 24 weeks | Ulcer area estimated using maximum width and length of the ulcer to calculate the area of an ellipse. We have previously shown this approach to be highly correlated with digital calculation of measured area (r=0.92). | square centimetres | MEAN |
| SECONDARY | Change in Health-related Quality of Life (Short Form 36) | Baseline, 24 weeks | Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomized. | units on a scale | MEAN |
| SECONDARY | Change in Health-related Quality of Life (EuroQol-5D 3L) | Baseline, 24 weeks | Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomised. | score on a scale | MEAN |
| SECONDARY | Change in Health-related Quality of Life (Charing Cross Venous Ulcer Questionnaire) | 24 weeks | Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomised. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Adherence to Treatment | 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Adverse Events at 24 Weeks | 24 weeks | Only participants that reported any reported untoward medical event were included in this analysis. | Number of events | COUNT_OF_UNITS |
Source ClinicalTrials.gov
Results by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Complete Healing of Reference Ulcer | Aspirin | 77 | 95% Confidence Interval 56 to 98 | days | |
| Time to Complete Healing of Reference Ulcer | Placebo | 69 | 95% Confidence Interval 56 to 98 | days | |
| Number of Participants With Healed Venous Leg Ulcers | Aspirin | 88 | Participants | ||
| Number of Participants With Healed Venous Leg Ulcers | Placebo | 101 | Participants | ||
| Change in Estimated Ulcer Area | Aspirin | 4.1 | Standard Error 0.4 | square centimetres | |
| Change in Estimated Ulcer Area | Placebo | 4.8 | Standard Error 0.4 | square centimetres | |
| Change in Health-related Quality of Life (Short Form 36) | Aspirin | Physical Functioning | 5.0 | Standard Error 2.2 | units on a scale |
| Change in Health-related Quality of Life (Short Form 36) | Placebo | Physical Functioning | 3.8 | Standard Error 2.2 | units on a scale |
| Change in Health-related Quality of Life (Short Form 36) | Aspirin | Role Physical | 11.7 | Standard Error 3.4 | units on a scale |
| Change in Health-related Quality of Life (Short Form 36) | Placebo | Role Physical | 10.3 | Standard Error 3.4 | units on a scale |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aspirin | 125 | |
| Overall Study | STARTED | Placebo | 126 | |
| Overall Study | COMPLETED | Aspirin | 121 | |
| Overall Study | COMPLETED | Placebo | 121 | |
| Overall Study | NOT COMPLETED | Aspirin | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events98
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Aspirin | 1 | 125 | 1 |
| other | Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 126 | 0 |
| other | Bleeding from any lower leg ulceration | Blood and lymphatic system disorders | Aspirin | 2 | 125 | 2 |
| other | Bleeding from any lower leg ulceration | Blood and lymphatic system disorders | Placebo | 2 | 126 | 2 |
| other | Infection of ulceration, any lower leg ulceration | Infections and infestations | Aspirin | 1 | 125 | 1 |
| other | Infection of ulceration, any lower leg ulceration | Infections and infestations | Placebo | 3 | 126 | 4 |
| other | Developed any new lower leg ulceration | Skin and subcutaneous tissue disorders | Aspirin | 1 | 125 | 1 |
| other | Developed any new lower leg ulceration | Skin and subcutaneous tissue disorders | Placebo | 3 | 126 | 3 |
| other | Extension of reference ulceration | Skin and subcutaneous tissue disorders | Aspirin | 1 | 125 | 1 |
| other | Extension of reference ulceration | Skin and subcutaneous tissue disorders | Placebo | 2 | 126 | 2 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aspirin | 2 | 125 |
| Total, all-cause mortality | Placebo | 0 | 126 |
| Total, other adverse events | Aspirin | 20 | 125 |
| Total, other adverse events | Placebo | 18 | 126 |
| Total, serious adverse events | Aspirin | 11 | 125 |
| Total, serious adverse events | Placebo | 10 | 126 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aspirin vs Placebo: Number of Participants With Adherence to Treatment | Trial comparisons |
| Aspirin vs Placebo: deaths from any cause | Trial comparisons |
| Aspirin vs Placebo: Number of Participants With Healed Venous Leg Ulcers | Trial comparisons |
| Aspirin vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02158806
GET https://conductscience.org/api/trials/v1/NCT02158806/results?page=2