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

NCT06693570 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-01-24

No results posted yet for this study

Summary

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.

Conditions

  • Venous Leg Ulcer (VLU)
  • Venous Leg Ulcers
  • Venous Leg
  • Nonhealing Venous Leg Ulcer

Interventions

OTHER

Intact Fish Skin Graft (IFSG) + Standard of Care

Participants will receive weekly applications of MariGen and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

OTHER

Standard of Care

Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Sponsors & Collaborators

  • Serena Group

    collaborator OTHER

  • Kerecis Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-25
Primary Completion
2026-04-30
Completion
2026-11-30

Countries

  • United States

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 NCT06693570 on ClinicalTrials.gov