Not a traditional drug phase: Diosmin for Scleroderma, Systemic
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.
Official registry: https://clinicaltrials.gov/study/NCT06256575 · Primus Pharmaceuticals · enrollment listed as 45
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Diosmin, or Placebo. The registry lists allocation as randomized. 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).
They plan to enroll about 45 people at 5 sites. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin: A Randomized, Double-blind, Placebo-controlled Multi-centre Pilot Study
Interventions: Diosmin, Placebo
Primary outcome (registry wording): Efficacy - Number (%) of healed baseline ulcers
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Diagnosis of systemic sclerosis (scleroderma)
- At least one "active" digital ulcer
- Medication for systemic sclerosis unchanged for 30 days
Who the registry excludes
- Infection or gangrene in ulcer
- Unstable heart, kidney, or liver disease
- Active infection of any type
- Current cancer treatment or uncured cancer
- Pregnancy or breast feeding
Public study contact (from the registry)
Lukban
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
5 listed- 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)
FAQ about this NCT record
Is NCT06256575 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06256575?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06256575?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary