Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin: A Randomized, Double-blind, Placebo-controlled Multi-centre Pilot Study
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Combination product
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of systemic sclerosis (scleroderma)
• At least one active digital ulcer
• Medication for systemic sclerosis unchanged for 30 days
Locations
Other Locations
Canada
Saint Joseph Health Care Centre
RECRUITING
London
Mount Sinai Health System
NOT_YET_RECRUITING
Toronto
Contact Information
Primary
Lukban
jlukban@primusrx.com
(480) 483-1410
Backup
Sanstead
msanstead@primusrx.com
919-810-9722
Time Frame
Start Date: 2025-05-02
Estimated Completion Date: 2027-08-15
Participants
Target number of participants: 45
Treatments
Active_comparator: Active
Vasculera 630 mg, tablet, two (2) times per day for eight (8) weeks
Placebo_comparator: Placebo
Cornstarch, one (1) capsule, two (2) times per day for eight (8)
Related Therapeutic Areas
Sponsors
Collaborators: KGK Science Inc.
Leads: Primus Pharmaceuticals