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

December 2, 2025 updated by: Primus Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • Recruiting
        • University of Calgary
        • Contact:
          • Larche', MD
        • Contact:
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4K4
    • Ontario
      • London, Ontario, Canada, N6A 4V2
      • Ottawa, Ontario, Canada, K1H 7W9
        • Recruiting
        • The Ottawa Hospital
        • Contact:
          • Maltez, MD
        • Contact:
      • Toronto, Ontario, Canada, M5T 3L9
        • Recruiting
        • Mount Sinai Health System
        • Contact:
        • Contact:
          • Shafina Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active
Vasculera 630 mg, tablet, two (2) times per day for eight (8) weeks
Combination product: Diosmin
A medical food of diosmin and alka4-complex
Other Names:
  • Vasculera
Placebo Comparator: Placebo
Cornstarch, one (1) capsule, two (2) times per day for eight (8)
Other: Placebo
Corn starch one (1) capsule twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - Number (%) of healed baseline ulcers
Time Frame: Screening, Day 1, Day 28, Day 56
Number (%) of healed baseline ulcers and change in net ulcer burden
Screening, Day 1, Day 28, Day 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - number of adverse events
Time Frame: Screening, Day 1, Day 28, Day 56
The number of product related adverse events experienced
Screening, Day 1, Day 28, Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Primus Pharmaceuticals

Collaborators

KGK Science Inc.

Investigators

  • Study Director: Lukban, Primus Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2025

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

August 15, 2027

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 13, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVDUS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

Primus director of clinical research will review requests submitted via email.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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