Trial · NCT05005052
Sulodexide in the Treatment of Chronic Primary Venous Disease of the Lower Extremities
NCT05005052, Phase 3, Unknown, Value Outcomes Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sulodexide in the Treatment of Chronic Primary Venous Disease of the Lower Extremities. Trials, record NCT05005052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05005052
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sulodexide in the Treatment of Chronic Primary Venous Disease of the Lower Extremities
- NCT number
- NCT05005052
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 290 participants, estimated
- Lead sponsor
- Value Outcomes Ltd.
- Conditions
- Chronic Venous Disease, Chronic Insufficiency Venous
- Interventions
- Vessel, Placebo
- First posted
- 2021-08-13
- Last updated
- 2023-06-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Revised Venous Clinical Severity Score (rVCSS) | 24 weeks of treatment | A minimal decrease in rVCSS score by 4 points will be considered a clinically significant response to treatment. |
| Secondary | Revised Venous Clinical Severity Score (rVCSS) | 4, 8 and 12 weeks of treatment | A minimal decrease in rVCSS score by 4 points will be considered a clinically significant response to treatment. |
| Secondary | Volume in lower limb | 4, 8, 12 and 24 weeks of treatment | The decrease of lower limb volume of at least 30 mL will be determined using water displacement leg volumetry and will be considered a clinically significant response to treatment. |
| Secondary | Visual Analogue Scale (VAS) | 4, 8, 12 and 24 weeks of treatment | Decrease in mean pain on Visual Analogue Scale. |
| Secondary | Work Productivity and Activity Impairment (WPAI questionnaire) | 8 and 24 weeks of treatment | Increase in mean work productivity in WPAI questionnaire. |
| Secondary | EQ-5D questionnaire | 8 and 24 weeks of treatment | Increase in the mean generic quality of life in EQ-5D questionnaire. |
| Secondary | Chronic Venous Insufficiency Quality of Life (CIVIQ-20 questionnaire) | 8 and 24 weeks of treatment | Increase in the mean disease-specific quality of life in CIVIQ-20 questionnaire. |
| Secondary | Mean time of clinically significant worsening rVCSS | 4, 8, 12 and 24 weeks of treatment | Mean time of worsening the rVCSS score since study initiation of at least 4 points. The difference will be visualized using Kaplan-Meier estimates and tested using Cox proportional-hazards models. |
| Secondary | Compression therapy initiation | 4, 8, 12 and 24 weeks of treatment | Mean time of duration of initiation of compression therapy since study initiation. The difference will be visualized using Kaplan-Meier estimates and tested using Cox proportional-hazards models. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05005052
GET https://conductscience.org/api/trials/v1/NCT05005052/registered