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

Inclusion Criteria3

  • Diagnosis of systemic sclerosis (scleroderma)
  • At least one "active" digital ulcer
  • Medication for systemic sclerosis unchanged for 30 days

Exclusion Criteria6

  • 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

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