Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis
Recruiting · NCT06256575 · Interventional (participants receive a specific treatment) · Lead sponsor: Primus Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
DiosminPlacebo
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
5 locations listed.
- 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