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

Not Applicable

Not yet recruiting

• Conditions: Digital Ulcer; Scleroderma, Systemic
• Interventions: Combination Product: Diosmin; Other: Placebo

• Registration Number: NCT06256575
• Lead Sponsor: Primus Pharmaceuticals

Brief 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.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-13
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Study Start: 2024-12-15
• Primary Completion: 2025-07-15
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Diosmin	Vasculera 630 mg, tablet, two (2) times per day for eight (8) weeks
Placebo	Placebo	Cornstarch, one (1) capsule, two (2) times per day for eight (8)

Primary Outcome Measures

Name	Time	Method
Efficacy - Number (%) of healed baseline ulcers	Screening, Day 1, Day 28, Day 56	Number (%) of healed baseline ulcers and change in net ulcer burden

Secondary Outcome Measures

Name	Time	Method
Safety - number of adverse events	Screening, Day 1, Day 28, Day 56	The number of product related adverse events experienced