Recruiting

Diosmin

Sponsor:

Primus Pharmaceuticals

Code:

NCT06256575

Conditions

Scleroderma, Systemic

Digital Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diosmin

Placebo

Study Details

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

Scleroderma, Systemic

Digital Ulcer

Study ID

NCT06256575

Start date

May 2, 2025

Status verified date

Sep, 2026

Completion date

Aug 15, 2027

Anticipated

Primary completion date

Jul 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active

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

placebo comparator: Placebo

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

Interventions

Diosmin

A medical food of diosmin and alka4-complex

Placebo

Corn starch one (1) capsule twice daily

Primary outcome measure

  • Efficacy - Number (%) of healed baseline ulcers [ Time Frame: Screening, Day 1, Day 28, Day 56 ]

Central Contacts and Locations

Central contacts

Lukban

(480) 483-1410jlukban@primusrx.com

Mary L Sanstead

480-250-6689msanstead@primusrx.com

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Rebutoc

rarebuto@ucalgary.ca

Saint Joseph Health Care Centre

Recruiting

London, Ontario, Canada, N6A 4V2

Contacts

Clinical Study Administrator

+1-519.646.6100jillian.bylsma@sjhc.london.on.ca

Research Coordinator

+1-(519) 646-6000amanda.phlilip@sjhc.london.on.ca

Principal Investigator:

Division Head Rheumotology

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 7W9

Contacts

Saidi

nasaidi@ohri.ca

Mount Sinai Health System

Recruiting

Toronto, Ontario, Canada, M5T 3L9

Contacts

Director, Toronto Scleroderma Program

+1-416-586-4800Shafina.hasmani@sinaihealth.ca

More Information

Sponsor

Primus Pharmaceuticals

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • SSc
  • Digital Ulcers
  • Sclerosis
  • Scleroderma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Primus Pharmaceuticals on 2026-09-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.