Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis
Scleroderma, Systemic · Digital Ulcer
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 45 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Quadruple masked
Active
Vasculera 630 mg, tablet, two (2) times per day for eight (8) weeks
Combination Product: Diosmin
Placebo
Cornstarch, one (1) capsule, two (2) times per day for eight (8)
Other: Placebo
Diosmin COMBINATION_PRODUCT
A medical food of diosmin and alka4-complex
Placebo OTHER
Corn starch one (1) capsule twice daily
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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 measures
Safety - number of adverse events
Time frame: Screening, Day 1, Day 28, Day 56
The number of product related adverse events experienced
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (5)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
5 locations
University of CalgaryCalgary, Alberta, CanadaRecruiting
Dalhousie UniversityHalifax, Nova Scotia, CanadaRecruiting
Saint Joseph Health Care CentreLondon, Ontario, CanadaRecruiting
The Ottawa HospitalOttawa, Ontario, CanadaRecruiting
Mount Sinai Health SystemToronto, Ontario, CanadaRecruiting
Study team and timeline
- Lead sponsor
- Primus Pharmaceuticals
- Study start
- May 2, 2025 Actual
- Primary completion
- Jul 15, 2027 Estimated
- Study completion
- Aug 15, 2027 Estimated
- First posted
- Feb 13, 2024 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin: A Randomized, Double-blind, Placebo-controlled Multi-centre Pilot Study
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026