An interventional study of Diosmin and Placebo in Scleroderma, Systemic and Digital Ulcer, sponsored by Primus Pharmaceuticals. Recruiting at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Primus Pharmaceuticals · Not applicable, Interventional, and Treatment
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.
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). The study will include 21-45 participants randomly given active product or inactive product (placebo). Two (2) out of every three (3) participants enrolled will receive active product. The participants will have four (4) visits over eight (8) weeks. At each visit physical exams and photos will be performed. Each person will also be asked a variety of questions describing level of pain and any changes to their lifestyle.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 45 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Primus Pharmaceuticals is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Vasculera 630 mg, tablet, two (2) times per day for eight (8) weeks
Combination Product: Diosmin
Cornstarch, one (1) capsule, two (2) times per day for eight (8)
Other: Placebo
A medical food of diosmin and alka4-complex
Also known as: Vasculera
Corn starch one (1) capsule twice daily
Efficacy - Number (%) of healed baseline ulcers
Number (%) of healed baseline ulcers and change in net ulcer burden
Time frame: Screening, Day 1, Day 28, Day 56
Safety - number of adverse events
The number of product related adverse events experienced
Time frame: Screening, Day 1, Day 28, Day 56
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan
Time frame: starting 6 months after publication
Access criteria: Primus director of clinical research will review requests submitted via email.
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Jul 2027, 26 months after the start.
Of 100 interventional studies with no phase under Scleroderma, Systemic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 26 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Diosmin
Primus Pharmaceuticals