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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrimus Pharmaceuticals

About 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.

Eligibility criteria

Qualifiers

Diagnosis of systemic sclerosis (scleroderma)

At least one "active" digital ulcer

Medication for systemic sclerosis unchanged for 30 days

Disqualifiers

Infection or gangrene in ulcer

Citrus allergy

Unstable heart, kidney, or liver disease

Active infection of any type

Trial design

Treatments tested in this trial

  • Diosmin
  • Placebo

Treatment groups

45 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Primus Pharmaceuticals

Lead sponsor

KGK Science Inc.

Collaborator