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

NCT06693570 | Recruiting Phase 4

• 2 other identifiers: KS-1010Pro00081893
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fish Skin Graft; Intact Fish Skin Graft

Outcome Measures

Primary Outcomes (1)

• The percentage of target ulcers achieving complete wound closure

  The percentage of target ulcers achieving complete wound closure in 12 weeks

  [Time Frame: 1-12 Weeks]

Secondary Outcomes (7)

• Time to closure

  [Time Frame: 1-12 weeks]

• Percent area change

  [Time Frame: 1-12 weeks]

• Adverse Events

  [Time Frame: 1-12 weeks]

• Change in pain in target ulcer

  [Time Frame: 1-12 weeks]

• Visits and product applications needed to close the ulcer

  [Time Frame: 1-12 weeks]

Study Arms (2)

Intact Fish Skin Graft (IFSG) + Standard of Care

EXPERIMENTAL

Up to 12 visits with Intact Fish Skin Graft (IFSG) + Standard of Care.

Other: Intact Fish Skin Graft (IFSG) + Standard of Care

Standard of Care

ACTIVE COMPARATOR

Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.

Other: Standard of Care

Interventions

Intact Fish Skin Graft (IFSG) + Standard of Care OTHER

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

Intact Fish Skin Graft (IFSG) + Standard of Care

Standard of Care OTHER

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be at least 18 years of age or older.
• 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.
• No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.
• 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.
• 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:
• ABI between 0.7 and ≤ 1.3;
• TBI ≥ 0.6;
• TCOM ≥ 40 mmHg;
• PVR: biphasic.

You may not qualify if:

• Subjects must have a Functional Ambulatory Category Score (FACS) of 3 or greater.
• Subjects must consent to using the prescribed compression method for the duration of the study.
• Subjects must agree to attend the weekly study visits required by the protocol.
• Subjects must be willing and able to participate in the informed consent process.
• The potential subject is known to have a life expectancy of \< 6 months.
• The index ulcer is determined to be due to a condition other than venous insufficiency.
• The target ulcer exposes muscle, tendon, or bone.
• The target ulcer exhibits overt clinical signs and symptoms of infection with cellulitis surrounding the wound margin.
• The target ulcer has known or suspected skin malignancy.
• The target ulcer has been previously exposed to radiation.
• The target ulcer duration is greater than one year having received high level compression without closure for a year or more.
• The potential subject has end stage renal disease requiring dialysis.
• The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
• A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
• The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a cellular or tissue-based product (CTP) in the 30 days prior to the initial screening visit.

Sponsors & Collaborators

• Kerecis Ltd.: lead
• Serena Group: collaborator

Study Sites (1)

Serena Group- Monroeville

Monroeville, Pennsylvania, 15146, United States

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Barkley Booker

CONTACT

888-960-1343; bbooker@serenagroups.com

Thomas Serena, MD

CONTACT

814-688-4000; serena@serenagroups.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter Prospective Randomized Comparative Effectiveness Clinical Trial

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: November 25, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 24, 2025

Record last verified: 2024-11

Locations

US (1)