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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv9
  2. Study sites: 2 to 5v8
  3. Trial status: Not Yet Recruiting to Recruitingv7 Show 4 more changesShow less
    • Primary completion date: Jul 15, 2025 to Jul 15, 2027
    • Start date changed from estimate of Dec 15, 2024 to May 2, 2025
    • Study sites: 0 to 2
    • Study completion date: Jul 15, 2025 to Aug 15, 2027
  4. Start date: Oct 15, 2024 to Dec 15, 2024v6
  5. Start date: Jul 15, 2024 to Oct 15, 2024
    • Study title revised
    v5
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  1. Start date: May 15, 2024 to Jul 15, 2024v4 Show 6 more changesShow less
    • Primary endpoint revised
    • Primary completion date: May 15, 2025 to Jul 15, 2025
    • Study completion date: Jun 15, 2025 to Jul 15, 2025
    • Interventions: Corn starch (Drug), Diosmin plus Diosmetin (Combination Product) to Diosmin (Combination Product), Placebo (Other)
    • Secondary endpoint revised
    • Study description expanded, about 95 words
  2. Interventions: Diosmin, diosmetin (Drug) to Corn starch (Drug), Diosmin plus Diosmetin (Combination Product)v3
  3. Interventions: Diosmin-Diosmetin (Other) to Diosmin, diosmetin (Drug)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06256575
Lead Sponsor Primus Pharmaceuticals
Collaborators: KGK Science Inc.
Conditions
(from sponsor)		 Scleroderma, Systemic, Digital Ulcer
Related terms digital ulcers, Scleroderma, Diffuse, Scleroderma, Systemic, Sclerosis
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov