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
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