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NCT06256575 Clinical Trial

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

Scleroderma, Systemic Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06256575
Other study ID # PVDUS-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 15, 2024
Est. completion date July 15, 2025

Study information
Verified date February 2024
Source Primus Pharmaceuticals
Contact Lukban
Phone (480) 483-1410
Email jlukban@primusrx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 45
Est. completion date July 15, 2025
Est. primary completion date July 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Combination Product:
• Diosmin
A medical food of diosmin and alka4-complex
Other:
• Placebo
Corn starch one (1) capsule twice daily

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Primus Pharmaceuticals KGK Science Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy - Number (%) of healed baseline ulcers Number (%) of healed baseline ulcers and change in net ulcer burden Screening, Day 1, Day 28, Day 56
Secondary Safety - number of adverse events The number of product related adverse events experienced Screening, Day 1, Day 28, Day 56
See also
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