Placental Tissue + Standard Care for Venous Leg Ulcers
(EVOLVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Research Director
Principal Investigator
Cellution Biologics
Are You a Good Fit for This Trial?
This trial is for adults 18 or older with a venous leg ulcer that hasn't healed after at least 4 weeks of standard care. The ulcer must be between 0.7 and 20 cm² in size, and participants need to meet certain blood flow and health criteria.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Dehydrated Human Placenta Tissue (dHPT)
Trial Overview
The study compares the effectiveness of treating venous leg ulcers using standard wound care alone versus standard care plus dehydrated human placental tissue (dHPT). Some patients may switch treatments during the study.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cellution Biologics
Lead Sponsor
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