Actively Recruiting
Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis
Led by Primus Pharmaceuticals · Updated on 2025-12-04
45
Participants Needed
5
Research Sites
119 weeks
Total Duration
On this page
Sponsors
P
Primus Pharmaceuticals
Lead Sponsor
K
KGK Science Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of systemic sclerosis (scleroderma)
- At least one "active" digital ulcer
- Medication for systemic sclerosis unchanged for 30 days
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Actively Recruiting
2
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 4K4
Not Yet Recruiting
3
Saint Joseph Health Care Centre
London, Ontario, Canada, N6A 4V2
Actively Recruiting
4
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9
Actively Recruiting
5
Mount Sinai Health System
Toronto, Ontario, Canada, M5T 3L9
Actively Recruiting
Research Team
L
Lukban
CONTACT
M
Mary L Sanstead
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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