Diosmin for healing finger (digital) ulcers in scleroderma
Official title: Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin: A Randomized, Double-blind, Placebo-controlled Multi-centre Pilot Study
Run by Primus Pharmaceuticals · NCT06256575 · Data updated 2026-11-12
This study will test whether the pill diosmin can safely help heal open finger ulcers in people with systemic sclerosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Primus Pharmaceuticals Industry-sponsored |
| Locations | 5 sites (Calgary, Alberta and 4 other locations) |
| Status | Recruiting |
| Started | May 2, 2025 |
| Main results expected | July 15, 2027 |
| Study ends | August 15, 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT06256575 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
University of Calgary
Calgary, Alberta, Canada Recruiting -
Dalhousie University
Halifax, Nova Scotia, Canada 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.