Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis

Primus Pharmaceuticals

Status: Not yet enrolling

Conditions: Scleroderma, Systemic; Digital Ulcer

Treatments: Other: Placebo; Combination Product: Diosmin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06256575

PVDUS-01

Details and patient eligibility

About

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.

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

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

Treatment:

Combination Product: Diosmin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo