What side effects are associated with this type of intervention?

Common treatments for Post-Thrombotic Syndrome (PTS) that aim to improve venous tone, reduce inflammation, and enhance lymphatic drainage, such as Micronized Purified Flavonoid Fraction (MPFF), generally have a favorable safety profile. However, potential side effects may include gastrointestinal disturbances (e.g., nausea, diarrhea), headaches, and allergic reactions. It is important for patients to discuss these potential side effects with their healthcare provider to ensure the benefits outweigh the risks.

What prior FDA approvals exist?

There is limited information on specific FDA approvals for the treatment of Post-Thrombotic Syndrome (PTS) that directly align with the mechanisms of Micronized Purified Flavonoid Fraction (MPFF). MPFF is believed to improve venous tone, reduce inflammation, and enhance lymphatic drainage. While there are various treatments for PTS, including compression therapy and anticoagulants, specific drugs with similar mechanisms to MPFF are not well-documented in FDA approvals. Patients should consult their healthcare providers for the most current and personalized treatment options.

What other types of research exist?

Promising novel alternatives to MPFF for PTS patients include: 1) Hemoperfusion with polymyxin-B immobilized fiber, which has shown improvement in oxygenation and survival rates in lung injury contexts, suggesting potential anti-inflammatory benefits. 2) Intravenous recombinant thrombomodulin (rhTM), although not effective in a specific trial for AE-IPF, its anti-inflammatory and anticoagulant properties may offer benefits in PTS. 3) Salsalate, which has shown efficacy in slowing kidney cyst growth and may have anti-inflammatory effects relevant to PTS. These alternatives should be discussed with a healthcare provider to evaluate their suitability for individual patients.

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Flavonoid

MPFF for Post-Thrombotic Syndrome (MUFFIN-PTS Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for Post-Thrombotic Syndrome (PTS) aim to improve venous function, reduce inflammation, and enhance lymphatic drainage. Micronized Purified Flavonoid Fraction (MPFF) is thought to improve venous tone, reduce inflammation, and enhance lymphatic drainage, which may alleviate symptoms of PTS and improve quality of life (QOL). These mechanisms are crucial for PTS patients as they help reduce pain, swelling, and other debilitating symptoms, thereby enhancing overall mobility and daily functioning.

Phase 3

Waitlist Available

Led By Susan R Kahn, MD, MSc

Research Sponsored by Sir Mortimer B. Davis - Jewish General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females of childbearing age must use medically approved method of birth control and must have negative pregnancy test results at the time of randomization

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

Must not have

Age<18 years

Liver cirrhosis Child-Pugh class C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 9 months

Awards & highlights

Pivotal Trial

Summary

This trial tests if a pill made from purified plant compounds can help people with chronic leg vein issues after a blood clot. The goal is to see if it improves their symptoms and quality of life by making their veins work better and reducing swelling. Micronized purified flavonoid fraction (MPFF) has been studied for its effectiveness in improving symptoms and quality of life in patients with chronic venous disease.

Who is the study for?

The MUFFIN-PTS Trial is for individuals with Post-Thrombotic Syndrome who experience symptoms like heaviness, cramps, pain, and leg swelling. Participants must be adults not on venoactive drugs recently, without severe liver or kidney disease, not pregnant or breastfeeding, and able to consent.

What is being tested?

This trial tests if taking Micronized Purified Flavonoid Fraction (MPFF) daily for six months can improve symptoms and quality of life in Post-Thrombotic Syndrome patients compared to a placebo.

What are the potential side effects?

Potential side effects of MPFF are generally mild but may include gastrointestinal discomfort such as upset stomach or diarrhea. Allergic reactions could occur in those sensitive to flavonoids.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am using birth control and my pregnancy test was negative.

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I have a Villalta score of 5 or more and experience daily heaviness, cramps, pain, or swelling in one leg due to a past blood clot.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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My liver condition is severe (Child-Pugh class C).

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I have changes in my mental status, either suddenly or over time.

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I am currently hospitalized.

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I have severe kidney disease and may be on dialysis.

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I have an open sore on the same side as my vein problem.

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I cannot speak English or French.

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I have had a blood clot in my leg within the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in PTS

Cramps

General Quality of life

+16 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: VenixxaActive Control1 Intervention

Micronized Purified Flavonoid Fraction (MPFF) for 6 months MPFF 500 mg, BID (morning and evening) for 6 months

Group II: PlaceboPlacebo Group1 Intervention

Placebo for 6 months 1 Tablet, BID (morning and evening) for 6 months

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Post-Thrombotic Syndrome (PTS) aim to improve venous function, reduce inflammation, and enhance lymphatic drainage. Micronized Purified Flavonoid Fraction (MPFF) is thought to improve venous tone, reduce inflammation, and enhance lymphatic drainage, which may alleviate symptoms of PTS and improve quality of life (QOL). These mechanisms are crucial for PTS patients as they help reduce pain, swelling, and other debilitating symptoms, thereby enhancing overall mobility and daily functioning.

The effect of exogenous phosphocreatine on maximal walking distance, blood rheology, platelet aggregation, and fibrinolysis in patients with intermittent claudication.Role of platelet-activating factor (PAF) in platelet accumulation in rabbit skin: effect of the novel long-acting PAF antagonist, UK-74,505.Alterations in platelet function in patients receiving interleukin-6 as cytokine therapy.