The MUFFIN-PTS Trial

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Criteria

Inclusion Criteria:

• Villalta score >4 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

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