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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in PTS
Timeframe: 6 months
Trial details
NCT IDNCT03833024
SponsorSir Mortimer B. Davis - Jewish General Hospital