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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Nov 25, 2024

Status verified

Nov 2024

Primary completion

Apr 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Intact Fish Skin Graft (IFSG) + Standard of Care
  Up to 12 visits with Intact Fish Skin Graft (IFSG) + Standard of Care.
• Active Comparator: Standard of Care
  Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.

Primary Outcome Measure

The percentage of target ulcers achieving complete wound closure [ Time Frame: [Time Frame: 1-12 Weeks] ]

Central Contacts

• Barkley Booker
  888-960-1343
  [email protected]
• Thomas Serena, MD
  814-688-4000
  [email protected]

Locations (1)

Find similar trials in Monroeville, PA

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