Trial · NCT07432529
Design and Rationale of the COLT Study
NCT07432529, Phase 3, Not yet recruiting, Azienda Sanitaria Locale ASL 6, Livorno
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Design and Rationale of the COLT Study. Trials, record NCT07432529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07432529
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Design and Rationale of the COLT Study
- NCT number
- NCT07432529
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 940 participants, estimated
- Lead sponsor
- Azienda Sanitaria Locale ASL 6, Livorno
- Conditions
- Venous Thrombosis Deep (Limbs), Post-thrombotic Syndrome, Venous Thromboembolism (VTE), Venous Insufficiency
- Interventions
- Colchicine 0.5 MG Oral Tablet, Placebo
- First posted
- 2026-02-25
- Last updated
- 2026-02-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-thrombotic syndrome (PTS) | From the start of treatment to the 12-month follow-up visit | To determine whether addition of low-dose colchicine to standard anticoagulation reduces the incidence of PTS at 12 months in patients with acute proximal lower-limb DVT. PTS is defined as: chronic clinical condition that occurs after DVT, presenting with symptoms such as leg pain, heaviness, cramps, pruritus, and paresthesia, and signs such as edema, skin hyperpigmentation, venous ectasia, lipodermatosclerosis, or venous ulcer, in the previously thrombosed limb, between 3 to 12 months after the acute event, and not explained by other causes \[31\]. A Villalta score \> 5 is considered diagnostic for PTS. |
| Primary | Recurrent venous thromboembolism. | From the start of treatment to the 12-month follow-up visit | To evaluate the effect of low-dose colchicine added to standard anticoagulation on the incidence of recurrent venous thromboembolism (VTE), defined as objectively confirmed recurrent DVT and/or pulmonary embolism (PE), within 12 months of the index event. |
| Secondary | Longitudinal evaluation of PTS severity | From the start of treatment to the 12-month follow-up visit | Subgroup analysis evaluating differences in efficacy of low-dose colchicine added to standard anticoagulation in mild (5-9) to moderate (10-14) to severe PTS (\> 15). |
| Secondary | Venous healing and function on imaging | From the start of treatment to the 12-month follow-up visit | To assess the effect of colchicine on venous recanalization and valvular competence at 3 months using duplex ultrasound, including: 1. vein compressibility, 2. residual vein obstruction, 3. presence of venous reflux. |
| Secondary | Change From Baseline in Health-Related Quality of Life (HRQOL) as Measured by the VEINES-QOL/Sym Questionnaire | From the start of treatment to the 12-month follow-up visit | Change from baseline in health-related quality of life as measured by the Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire. The VEINES-QOL score ranges from 0 to 100, with higher scores indicating better quality of life. The VEINES-Sym score ranges from 0 to 100, with higher scores indicating fewer symptoms. |
| Secondary | Adverse event and treatment discontinuation | From the start of treatment to the 12-month follow-up visit | To determine the 12-months safety profile of colchicine in this population (major and clinically relevant non-major bleeding, defined by ISTH definitions, gastrointestinal adverse events, neutropenia). |
| Secondary | Adherence and persistence to colchicine therapy | From the start of treatment to the 12-month follow-up visit | To evaluate adherence and persistence to colchicine treatment and to explore their association with clinical outcomes, including PTS severity and recurrent VTE. |
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/NCT07432529
GET https://conductscience.org/api/trials/v1/NCT07432529/registered