NCT06256575

Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis

Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin: A Randomized, Double-blind, Placebo-controlled Multi-centre Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Primus Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Scleroderma, Systemic
• Digital Ulcer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Diosmin	A medical food of diosmin and alka4-complex
OTHER	Placebo	Corn starch one (1) capsule twice daily

Timeline

• Start date: 2025-05-02
• Primary completion: 2027-07-15
• Completion: 2027-08-15
• First posted: 2024-02-13
• Last updated: 2025-12-04

Locations

5 sites across 1 country: Canada