NCT07230340

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

A Multicenter, Randomized Trial Evaluating Dehydrated Human Placenta Tissue (dHPT) and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers With Crossover for Subjects Randomized to Standard of Care

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Cellution Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In 2020, more than 4.5 billion people around the world were estimated to have chronic venous disease stages C1-C6, and approximately 3 in every 1000 people globally develop a VLU annually. While the pathophysiology of VLUs is complex, risk factors are thought to include noncompliance with compression therapy, incorrect ulcer diagnosis, obesity, and a history of deep vein thrombosis. It is estimated that 7% of VLUs do not heal within a 12-month period. As with DFUs, treatment of VLUs focuses on prevention. Low-income individuals, especially those from minority communities, often face difficulties in accessing advanced wound care centers. The estimated annual cost of treating VLUs in the United States in 2022 was over $4.9 billion, which includes expenses for practitioners, wound care products, hospital stays, medications, and compression therapy. Despite the well-established standard of care for chronic wounds, which includes sharp debridement, offloading, compression therapy, and maintaining proper moisture balance, a notable gap remains between clinical outcomes and desired results in chronic wound care. The reported recurrence rate for venous leg ulcers (VLUs) also ranges from 24% - 57%, illustrating the long-term burden this pathology places on patients. One approach to treating chronic wounds involves the use of cellular, acellular, and matrix-like products (CAMPs), which are defined as 'A broad category of biomaterials, synthetic materials, or biosynthetic matrices that support repair or regeneration of injured tissues through various mechanisms of action. The application of CAMPs in chronic wound treatment provides several benefits, including creating a protective environment for healing, covering deep structures, aiding surgical closure, enhancing functional outcomes, and improving appearance. The cellular category of CAMPS includes allografts, which are human donor tissue samples intended for use in other human patients. Utilizing dehydrated human placental tissue (dHPT) as an allograft displays considerable promise for chronic wound treatment.

Conditions

• Venous Leg Ulcer (VLU)

Interventions

Type	Name	Description
OTHER	Amnion-Intermediate-Chorion	Dehydrated human placental multilayer allograft derived from donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
PROCEDURE	Standard of Care (SOC)	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-11-17
• Last updated: 2025-12-16