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

NCT06256575 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-12-04

No results posted yet for this study

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. Physical exams and photos will be performed. A variety of questions will be asked describing level of pain and lifestyle changes.

Conditions

  • Scleroderma, Systemic
  • Digital Ulcer

Interventions

COMBINATION_PRODUCT

Diosmin

A medical food of diosmin and alka4-complex

OTHER

Placebo

Corn starch one (1) capsule twice daily

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • Primus Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lukban · Primus Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-02
Primary Completion
2027-07-15
Completion
2027-08-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06256575 on ClinicalTrials.gov