The MUFFIN-PTS Trial (NCT03833024) | Clinical Trial Compass
UnknownPhase 3
The MUFFIN-PTS Trial
Canada88 participantsStarted 2022-02-04
Plain-language summary
In this randomized controlled trial (RCT), the investigators will determine whether a 6-month course of oral Micronized Purified Flavonoid Fraction (MPFF 1000 mg daily), compared with placebo, improves the symptoms and signs of the post-thrombotic syndrome (PTS) and quality of life (QOL) at 6 months follow-up.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Villalta score ≥5 with at least two of the following four PTS manifestations (daily heaviness, cramps, pain, and objective edema) in the leg ipsilateral to a previous objectively diagnosed DVT, or DVT of unknown date but with presence of residual proximal or distal venous obstruction on ultrasound. Females of childbearing age must use medically approved method of birth control and must have negative pregnancy test results at the time of randomization.
Exclusion Criteria:
* Recent acute ipsilateral DVT (\<3 months)
* Active ipsilateral venous ulcer
* Acute or chronic altered mental status
* Any venoactive drug intake within 3 months of the start of the study
* Allergy or hypersensitivity to MPFF/Venixxa
* Age\<18 years
* Pregnant or breastfeeding women
* Life expectancy \<1 year
* Refuse or unwilling to provide consent
* Unable to speak English or French
* Alcohol/drug abuse
* Hospitalized patients
* End-stage kidney disease (dialysis, creatinine clearance \< 10ml/min)
* Liver cirrhosis Child-Pugh class C.
* Currently enrolled in other clinical trials, other than trials of prevention or treatment of venous thromboembolism
What they're measuring
1
Change in PTS
Timeframe: 6 months
Trial details
NCT IDNCT03833024
SponsorSir Mortimer B. Davis - Jewish General Hospital