Trial · NCT01295736
Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDY
NCT01295736, Phase 3, Completed, University Hospital, Lille
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDY. Trials, record NCT01295736. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01295736
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sildenafil Effect on Digital Ulcer Healing in sClerodErma SEDUCE STUDY
- NCT number
- NCT01295736
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 84 participants, actual
- Lead sponsor
- University Hospital, Lille
- Conditions
- Systemic Scleroderma
- Interventions
- Sildenafil, placebo
- First posted
- 2011-02-14
- Last updated
- 2026-05-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | time to healing of ischemic digital ulcers (DUs) in patients with scleroderma treated by sildenafil 20 mg TID versus placebo for 90 days | 90 days | |
| Secondary | To evaluate the time to healing of ischemic DUs (2 mm at entry and > 1 month and <3 months old) in patients with scleroderma treated by sildenafil 20 mg TID versus placebo for 90 days. | 90 days | |
| Secondary | To evaluate the change in the number of ischaemic DUs between baseline and day 90. | 90 days | |
| Secondary | To evaluate the proportion of patients with complete healing of all DUs present at baseline at day 90. | 90 days | |
| Secondary | To evaluate the proportion of patients with complete healing of all DUs (baseline DUs and new DUs) at day 90. | 90 days | |
| Secondary | To evaluate the proportion of patients who do not develop any new DU after 28 days of treatment with the study drug up to day 90. | 90 days | |
| Secondary | To evaluate the change between baseline and day 90 in hand function and pain. | 90 days | |
| Secondary | To evaluate the proportion of patients with complicated DUs (infection, gangrene, amputation, DU requiring IV prostanoids) over the 90 days period of treatment. | 90 days | |
| Secondary | To evaluate the evolution of the severity of Raynaud's phenomenon between baseline and day 90. | 90 days |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25995322 | RESULT |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01295736
GET https://conductscience.org/api/trials/v1/NCT01295736/registered