RecruitingNot ApplicableNCT06256575

Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis

Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin: A Randomized, Double-blind, Placebo-controlled Multi-centre Pilot Study


Sponsor

Primus Pharmaceuticals

Enrollment

45 participants

Start Date

May 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). Two (2) out of three (3) participants will receive active product. The participants will have four (4) visits over eight (8) weeks. Physical exams and photos will be performed. A variety of questions will be asked describing level of pain and lifestyle changes.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests diosmin — a plant-based compound with blood vessel-protecting properties — for treating painful digital ulcers (open sores on the fingers) in people with systemic sclerosis (scleroderma). Scleroderma is a chronic autoimmune disease that causes the skin and blood vessels to harden, reducing blood flow to the fingers and causing difficult-to-heal ulcers. **You may be eligible if...** - You have a confirmed diagnosis of systemic sclerosis (scleroderma) - You have at least one active digital ulcer on your fingers - Your scleroderma medications have not changed in the past 30 days **You may NOT be eligible if...** - Your ulcer is infected or has gangrene - You have a citrus allergy (diosmin is derived from citrus fruits) - You have unstable heart, kidney, or liver disease - You have an active infection of any type - You are currently being treated for cancer or have uncured cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTDiosmin

A medical food of diosmin and alka4-complex

OTHERPlacebo

Corn starch one (1) capsule twice daily


Locations(5)

University of Calgary

Calgary, Alberta, Canada

Dalhousie University

Halifax, Nova Scotia, Canada

Saint Joseph Health Care Centre

London, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Mount Sinai Health System

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06256575


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