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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 May 15, 2024
Est. completion date June 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-diosmetin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). . The study will include 21-45 patients who will randomly be given either active product or inactive product (placebo). Two (2) out of every three (3) patients enrolled will receive active product. The patients 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. Diosmin-Diosmetin is a naturally occurring compound found in citrus fruits and vegetables known as flavonoids. This product has been used to treat poor blood circulation in a variety of countries.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 45
Est. completion date June 15, 2025
Est. primary completion date May 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 plus Diosmetin
diosmin plus diosmetin one (1) capsule twice daily
Drug:
• Corn starch
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 Safety - Incidence, relationship, and severity of adverse events (AEs) and serious adverse events (SAEs) Incidence, relationship, and severity of adverse events (AEs) and serious adverse events (SAEs) Baseline to Visit 4 at Week 8
Secondary Efficacy - Number (%) of healed baseline ulcers Number (%) of healed baseline ulcers Number (%) of participants with at least one healed baseline ulcer Number (%) of healed baseline "cardinal" ulcers Number (%) of ulcers exhibiting > 50% healing Change in Net Ulcer Burden Screening to Visit 4 at 8 weeks
See also
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