Nonhealing Venous Leg Ulcers Treated With a Standard of Care (SoC) Alone or Standard of Care and Dehydrated Human Placenta Tissue (dHPT) With Crossover

Part of paid clinical trials in Rocky Mount, North Carolina.

Sponsor
Cellution Biologics
Study ID
NCT07230340
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Venous Leg Ulcer (VLU)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amnion-Intermediate-Chorion — OTHER
    Dehydrated human placental multilayer allograft derived from donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
  • Standard of Care (SOC) — PROCEDURE
    Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.

Study Details

The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of venous leg ulcers.

Key Dates

First listed
Nov 17, 2025
Start date
Feb 4, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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 10 weeks, whichever occurs first.
  • Experimental: AIC and Standard of Care
    Participants with a venous leg ulcer (VLU) will receive treatment with an Amnion-Intermediate-Chorion (AIC) sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first.

Primary Outcome Measure

Percentage of Venous Leg Ulcers with Complete Wound Closure [ Time Frame: 1-10 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Foot & Ankle Institute of the CarolinasRocky MountNorth Carolina27804-

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By research site
Foot & Ankle Institute of the Carolinas· Rocky Mount, NC

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