NCT06256575 Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis
| NCT ID | NCT06256575 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Primus Pharmaceuticals |
| Condition | Scleroderma, Systemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-05-02 |
| Primary Completion | 2027-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2025-05-02 with a primary completion date of 2027-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Lukban
STUDY DIRECTOR
Primus Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06256575 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Scleroderma, Systemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06256575 currently recruiting?
Yes, NCT06256575 is actively recruiting participants. Contact the research team at jlukban@primusrx.com for enrollment information.
Where is the NCT06256575 trial being conducted?
This trial is being conducted at Calgary, Canada, Halifax, Canada, London, Canada, Ottawa, Canada and 1 additional location.
Who is sponsoring the NCT06256575 clinical trial?
NCT06256575 is sponsored by Primus Pharmaceuticals. The principal investigator is Lukban at Primus Pharmaceuticals. The trial plans to enroll 45 participants.