Diosmin for healing finger (digital) ulcers in scleroderma
Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin: A Randomized, Double-blind, Placebo-controlled Multi-centre Pilot Study
This study will test whether the pill diosmin can safely help heal open finger ulcers in people with systemic sclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Primus Pharmaceuticals Industry-sponsored |
| Locations | 5 sites (Calgary, Alberta and 4 other locations) |
| Trial ID | NCT06256575 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled trial will enroll 21–45 participants with systemic sclerosis who have at least one active digital ulcer, with a 2:1 randomization to diosmin versus placebo. Participants will attend four clinic visits over eight weeks for physical exams, ulcer photography, and questionnaires about pain and daily function. The protocol emphasizes safety monitoring and measurement of ulcer healing over the two-month treatment period. Medication for systemic sclerosis must be stable before enrollment and common exclusions include infection, unstable organ disease, citrus allergy, current cancer therapy, and pregnancy.
Who should consider this trial
Good fit: Ideal candidates are adults with a confirmed diagnosis of systemic sclerosis who have at least one active digital ulcer and stable systemic sclerosis medications for 30 days, and who are able to attend visits at a participating site.
Not a fit: Patients with infected or gangrenous ulcers, unstable heart/kidney/liver disease, active infection, current cancer treatment, citrus allergy, or who are pregnant or breastfeeding are unlikely to benefit or are excluded from participation.
Why it matters
Potential benefit: If successful, diosmin could speed healing of digital ulcers, reduce pain, and improve hand function for people with systemic sclerosis.
How similar studies have performed: Diosmin is used for venous disorders but there is limited clinical evidence for treating scleroderma-related digital ulcers, so this application is relatively novel and exploratory.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Calgary, Alberta and 4 other locations
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
- Dalhousie University — Halifax, Nova Scotia, Canada (Not_yet_recruiting)
- Saint Joseph Health Care Centre — London, Ontario, Canada (Recruiting)
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
- Mount Sinai Health System — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Lukban
- Email: jlukban@primusrx.com
- Phone: (480) 483-1410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.