Diosmin for Digital Ulcers

Recruiting at 1 trial location

Overseen By Sanstead

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Primus Pharmaceuticals

Disqualifiers: Infection, Cancer, Pregnancy, others

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Lukban

Principal Investigator

Primus Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for individuals with systemic sclerosis (scleroderma) who have at least one active sore on their fingers. Participants should not have changed their scleroderma medication in the last 30 days.

Inclusion Criteria

I have been diagnosed with systemic sclerosis.

I currently have at least one open sore on my fingers or toes.

My medication for systemic sclerosis has been the same for the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Vasculera or placebo for eight weeks to assess safety and healing of digital ulcers

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diosmin

Trial Overview The study tests diosmin's safety and effectiveness in healing finger sores caused by scleroderma. Two-thirds of participants will receive diosmin, while others get a placebo over eight weeks with four check-ins.

How Is the Trial Designed?

Group I: Active Active Control 1 Intervention

Vasculera 630 mg, tablet, two (2) times per day for eight (8) weeks

Group II: Placebo Placebo Group 1 Intervention

Cornstarch, one (1) capsule, two (2) times per day for eight (8)

Who Is Running the Clinical Trial?

Primus Pharmaceuticals

Lead Sponsor

Trials

22

Recruited

2,400+

KGK Science Inc.

Industry Sponsor

Trials

82

Recruited

6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution