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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosis of systemic sclerosis (scleroderma) - At least one "active" digital ulcer - Medication for systemic sclerosis unchanged for 30 days Who Should NOT Join This Trial: - Infection or gangrene in ulcer - Citrus allergy - Unstable heart, kidney, or liver disease - Active infection of any type - Current cancer treatment or uncured cancer - Pregnancy or breast feeding Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Diagnosis of systemic sclerosis (scleroderma) * At least one "active" digital ulcer * Medication for systemic sclerosis unchanged for 30 days Exclusion Criteria: * Infection or gangrene in ulcer * Citrus allergy * Unstable heart, kidney, or liver disease * Active infection of any type * Current cancer treatment or uncured cancer * Pregnancy or breast feeding

Treatments Being Tested

COMBINATION_PRODUCT

Diosmin

A medical food of diosmin and alka4-complex

OTHER

Placebo

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