Scleroderma, SystemicNCT06256575
Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis
A study testing Diosmin in people with Scleroderma, Systemic and Digital Ulcer, run by Primus Pharmaceuticals at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic, Digital Ulcer
- What is being tested?
- Diosmin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 5 sitesCanada
- Study dates
- 2 May 2025to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of systemic sclerosis (scleroderma)
- At least one "active" digital ulcer
- Medication for systemic sclerosis unchanged for 30 days
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Larche', MD
Rebutoc, rarebuto@ucalgary.ca
- Not yet recruiting
Dalhousie University
Halifax, Nova Scotia, B3H 4K4
Sutton, MD
Linehan, tina.linehan@nshealth.ca
- Recruiting
Saint Joseph Health Care Centre
London, Ontario, N6A 4V2
Clinical Study Administrator, +1-519.646.6100 ext. 66333, jillian.bylsma@sjhc.london.on.ca
Research Coordinator, +1-(519) 646-6000 ext. 61228, amanda.phlilip@sjhc.london.on.ca
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 7W9
Maltez, MD
Saidi, nasaidi@ohri.ca
- Recruiting
Mount Sinai Health System
Toronto, Ontario, M5T 3L9
Director, Toronto Scleroderma Program, +1-416-586-4800, Shafina.hasmani@sinaihealth.ca
Shafina Health
About this study
Official title: 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.
Read the 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.
- Conditions
- Scleroderma, Systemic, Digital Ulcer
- Being tested
- Diosmin, Placebo
- Keywords
- SSc, Digital Ulcers, Sclerosis, Scleroderma
- Medical subject headings
- Scleroderma, Systemic, digital ulcers, Sclerosis, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiosminCombination product
Also called Vasculera
A medical food of diosmin and alka4-complex
PlaceboOther
Corn starch one (1) capsule twice daily
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Vasculera 630 mg, tablet, two (2) times per day for eight (8) weeks Receives: Combination Product: Diosmin |
| Placebo | Placebo comparator | Cornstarch, one (1) capsule, two (2) times per day for eight (8) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Number (%) of healed baseline ulcers
Number (%) of healed baseline ulcers and change in net ulcer burden
Measured: Screening, Day 1, Day 28, Day 56
Secondary outcomes (1)
Safety - number of adverse events
The number of product related adverse events experienced
Measured: Screening, Day 1, Day 28, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start2 May 2025
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel study of two (2) arms in which participants receive different interventions. Participants are randomized and assigned to the treatment or placebo arm at the beginning of the trial. They continue in that arm throughout the length of the trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Primus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- Lukban, Study director, Primus Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256575
- Sponsor's protocol ID
- PVDUS-01
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin: A Randomized, Double-blind, Placebo-controlled Multi-centre Pilot Study
- ClinicalTrials.gov ID
- NCT06256575
- Acronym / sponsor ID
- PVDUS-01
- Conditions
- Scleroderma, Systemic, Digital Ulcer
- Keywords
- SSc, Digital Ulcers, Sclerosis, Scleroderma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 2 May 2025 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel study of two (2) arms in which participants receive different interventions. Participants are randomized and assigned to the treatment or placebo arm at the beginning of the trial. They continue in that arm throughout the length of the trial.
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Combination Product: DiosminVasculera 630 mg, tablet, two (2) times per day for eight (8) weeks |
| Placebo | Placebo comparator | Other: PlaceboCornstarch, one (1) capsule, two (2) times per day for eight (8) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of systemic sclerosis (scleroderma)
- At least one "active" digital ulcer
- Medication for systemic sclerosis unchanged for 30 days
Key exclusion criteria (6 listed)
- Infection or gangrene in ulcer
- Citrus allergy
- Unstable heart, kidney, or liver disease
- Active infection of any type
- Current cancer treatment or uncured cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiosminAlso: VasculeraA medical food of diosmin and alka4-complex | Combination product | Active |
| PlaceboCorn starch one (1) capsule twice daily | Other | Placebo |
Primary outcome
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
1 secondary outcome
Safety - number of adverse events
Time frame: Screening, Day 1, Day 28, Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lukban study director
Primus Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diosmin in people with Scleroderma, Systemic and Digital Ulcer, run by Primus Pharmaceuticals at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukban ((480) 483-1410, jlukban@primusrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy - Number (%) of healed baseline ulcers (time frame: Screening, Day 1, Day 28, Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.