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RecruitingVenous Leg Ulcer (VLU)Venous Leg UlcersVenous Leg

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

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Kerecis Ltd.

You may qualify if…

  • ✓ 1. Subjects must be at least 18 years of age or older.
  • ✓ 2. Subjects must have a nonhealing venous leg ulcer present for a minimum of 4 weeks and cannot have received more than 52 weeks of high-level compression prior to the initial screening visit.
  • ✓ 3. No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.
  • ✓ 4. At randomization, subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 25 cm2 measured post-debridement.
  • ✓ 5. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
  • ✓ 1. ABI between 0.7 and ≤ 1.3;
  • ✓ 2. TBI ≥ 0.6;
  • ✓ 3. TCOM ≥ 40 mmHg;

You may not qualify if…

  • ✕ 1. The potential subject is known to have a life expectancy of \< 6 months.
  • ✕ 2. The index ulcer is determined to be due to a condition other than venous insufficiency.
  • ✕ 3. The target ulcer exposes muscle, tendon, or bone.
  • ✕ 4. The target ulcer exhibits overt clinical signs and symptoms of infection with cellulitis surrounding the wound margin.
  • ✕ 5. The target ulcer has known or suspected skin malignancy.
  • ✕ 6. The target ulcer has been previously exposed to radiation.
  • ✕ 7. The target ulcer duration is greater than one year having received high level compression without closure for a year or more.
  • ✕ 8. The potential subject has end stage renal disease requiring dialysis.

Where it's recruiting

Pennsylvania

Monroeville

Source: ClinicalTrials.gov · NCT06693570 · last updated 2025-01-24

Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard · TrialPath