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 trial explores whether diosmin can safely aid in healing open sores on fingers, known as digital ulcers, in individuals with systemic sclerosis (scleroderma). Participants will be divided into two groups: most will receive diosmin, while some will receive a placebo (a pill with no active medicine) for eight weeks. The study seeks individuals with systemic sclerosis who have at least one active finger sore and have not changed their medication for this condition in the past month. As an unphased trial, it offers a unique opportunity to contribute to understanding potential new treatments for systemic sclerosis.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but your medication for systemic sclerosis should not have changed in the last 30 days.

Is there any evidence suggesting that diosmin is likely to be safe for humans?

Research shows that Europe has used diosmin for over 35 years to treat venous blood flow issues, such as venous ulcers. This extensive use suggests diosmin is generally safe. However, specific safety information for treating finger ulcers in people with systemic sclerosis is lacking. Diosmin remains in a trial phase labeled "Not Applicable," indicating ongoing safety studies for this condition. Although the FDA has not approved diosmin for finger ulcers, its use in other conditions suggests potential safety. Always consult a healthcare provider for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for digital ulcers, like vasodilators or immunosuppressants, work by improving blood flow or reducing inflammation. But Diosmin offers a unique approach by enhancing vein health and reducing edema through its bioflavonoid properties. This natural compound may offer a gentler alternative with fewer side effects compared to traditional medications. Researchers are excited because Diosmin could improve healing and comfort for patients with digital ulcers without the harsh impacts of more aggressive treatments.

What evidence suggests that diosmin might be an effective treatment for digital ulcers?

Research has shown that diosmin has been used successfully in Europe for over 35 years to treat chronic vein problems and related issues, such as leg ulcers. This history suggests it might also help heal sores on the fingers in people with systemic sclerosis (scleroderma). Diosmin improves blood flow, which can aid in healing these open sores. Although specific data for finger sores is limited, its long history of use in similar conditions is promising. This trial will compare diosmin to a placebo to evaluate its effectiveness for finger sores. More studies are needed to confirm its effectiveness for finger sores, but early signs are hopeful. ^{2 3 4 6 7}

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06256575

Study of Diosmin for the Treatment of Digital Ulcers ... In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/461038

Study of Diosmin for the Treatment of Digital Ulcers in ... This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02683408

Study Details | NCT02683408 | Diosmiplex (Vasculera®) in ... Diosmin has been used successfully in Europe as a drug for chronic venous insufficiency and its complications, including venous ulcers for more than 35 years.

4. withpower.com withpower.com/trial/phase-scleroderma-systemic-4-2024-d112c

Diosmin for Digital Ulcers This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1078588405002315

Venous Leg Ulcer: A Meta-analysis of Adjunctive Therapy ... In validation data sets, ulcers with a high risk of failure to heal were those larger than 5 cm2 and those that had been present for more than 6 months.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06256575

Study of Diosmin for the Treatment of Digital Ulcers ... 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 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37335850/

Systemic pharmacological treatment of digital ulcers in ... Results: Forty-seven studies that evaluated the treatment efficacy or safety of pharmacological therapies were identified among 4250 references.