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Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers

Study acronym: THOR
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 24, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria revisedv5
  2. Start date changed from estimate of Nov 2024 to Nov 25, 2024v4
  3. Eligibility criteria shortened, about 21 wordsv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of hard-to-heal venous leg ulcers (VLU) between Intact Fish Skin Graft plus standard of care (IFSG/SOC) versus standard of care alone (SOC) over 12 weeks.
Trial Details
NCT Number NCT06693570
Lead Sponsor Kerecis Ltd.
Collaborators: Serena Group
Conditions
(from sponsor)		 Venous Leg Ulcer (VLU), Venous Leg Ulcers, Venous Leg, Nonhealing Venous Leg Ulcer
Related terms Varicose Ulcer
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov