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

Sponsor: Primus Pharmaceuticals • ClinicalTrials.gov ID: NCT06256575

Registry updated: 2026-09-11

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Description

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.

Interventions

Diosmin (Combination product)
A medical food of diosmin and alka4-complex
Placebo (Other)
Corn starch one (1) capsule twice daily

Eligibility criteria

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

Conditions

Scleroderma, Systemic Digital Ulcer

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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