Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis
NCT ID: NCT06256575
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2025-05-02
2027-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active
Vasculera 630 mg, tablet, two (2) times per day for eight (8) weeks
Diosmin
A medical food of diosmin and alka4-complex
Placebo
Cornstarch, one (1) capsule, two (2) times per day for eight (8)
Placebo
Corn starch one (1) capsule twice daily
Interventions
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Diosmin
A medical food of diosmin and alka4-complex
Placebo
Corn starch one (1) capsule twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least one "active" digital ulcer
* Medication for systemic sclerosis unchanged for 30 days
Exclusion Criteria
* Citrus allergy
* Unstable heart, kidney, or liver disease
* Active infection of any type
* Current cancer treatment or uncured cancer
* Pregnancy or breast feeding
18 Years
ALL
No
Sponsors
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KGK Science Inc.
INDUSTRY
Primus Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Lukban
Role: STUDY_DIRECTOR
Primus Pharmaceuticals
Locations
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University of Calgary
Calgary, Alberta, Canada
Dalhousie University
Halifax, Nova Scotia, Canada
Saint Joseph Health Care Centre
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Mount Sinai Health System
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Larche', MD
Role: primary
Sutton, MD
Role: primary
Maltez, MD
Role: primary
Shafina Health
Role: backup
Other Identifiers
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PVDUS-01
Identifier Type: -
Identifier Source: org_study_id
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