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

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.

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