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NCT Number: NCT06256575

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

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.

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Key information

Conditions

Scleroderma, Systemic Connective Tissue Diseases Digital Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Scleroderma, Diffuse Sclerosis Skin Diseases Skin and Connective Tissue Diseases digital ulcers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this 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). 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diosmin

Combination Product

A medical food of diosmin and alka4-complex

Other names: Vasculera

Placebo

Other

Corn starch one (1) capsule twice daily

Primary outcomes

  1. 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

Secondary outcomes

  1. Safety - number of adverse events

    Time frame: Screening, Day 1, Day 28, Day 56

    The number of product related adverse events experienced

Study contacts

Contact information is provided by the study sponsor or research team.

Lukban

CONTACT

[email protected]

(480) 483-1410

Mary L Sanstead

CONTACT

[email protected]

480-250-6689

Sponsors and collaborators

Lead sponsor

Primus Pharmaceuticals

Industry

Collaborators

  • KGK Science Inc.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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