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

NCT06256575 | Recruiting

• 1 other identifier: PVDUS-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 5

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.

Conditions

Digital Ulcer; Scleroderma, Systemic

Keywords

SSc; Digital Ulcers; Sclerosis; Scleroderma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety - number of adverse events

  Screening, Day 1, Day 28, Day 56

Study Arms (2)

Active

ACTIVE COMPARATOR

Vasculera 630 mg, tablet, two (2) times per day for eight (8) weeks

Combination Product: Diosmin

Placebo

PLACEBO COMPARATOR

Cornstarch, one (1) capsule, two (2) times per day for eight (8)

Other: Placebo

Interventions

Diosmin COMBINATION_PRODUCT

A medical food of diosmin and alka4-complex

Also known as: Vasculera

Active

Placebo OTHER

Corn starch one (1) capsule twice daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of systemic sclerosis (scleroderma)
• At least one "active" digital ulcer
• Medication for systemic sclerosis unchanged for 30 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Primus Pharmaceuticals: lead
• KGK Science Inc.: collaborator

Study Sites (5)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

Dalhousie University

Halifax, Nova Scotia, B3H 4K4, Canada

NOT YET RECRUITING

Saint Joseph Health Care Centre

London, Ontario, N6A 4V2, Canada

RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

RECRUITING

Mount Sinai Health System

Toronto, Ontario, M5T 3L9, Canada

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic; digital ulcers; Sclerosis; Scleroderma, Diffuse

Interventions

Diosmin

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lukban

  Primus Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Lukban

CONTACT

(480) 483-1410; jlukban@primusrx.com

Mary L Sanstead

CONTACT

480-250-6689; msanstead@primusrx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All subjects de-identified, all study staff blinded, all product labeled with number assignment, randomization performed by computer, number assignment conveyed to blinded study staff via computer.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a parallel study of two (2) arms in which participants receive different interventions. Participants are randomized and assigned to the treatment or placebo arm at the beginning of the trial. They continue in that arm throughout the length of the trial.

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: May 2, 2025
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 6 months after publication
• Access Criteria: Primus director of clinical research will review requests submitted via email.

Locations

CA (5)