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
Primus Pharmaceuticals
45 participants
May 2, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- Diagnosis of systemic sclerosis (scleroderma)
- At least one "active" digital ulcer
- Medication for systemic sclerosis unchanged for 30 days
Exclusion Criteria6
- 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
Interventions
A medical food of diosmin and alka4-complex
Corn starch one (1) capsule twice daily
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06256575