NCT07375160

Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing

A Retrospective, Real World Evidence (RWE) Trial to Evaluate the Safety and Efficacy of a Dehydrated Human Placenta Tissue (dHPT) for Wound Healing

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Cellution Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics allograft products with real-world evidence to support the clinical adoption in patients to manage chronic or surgical wounds.

Detailed description

Around 10.5 million Medicare beneficiaries were affected by chronic wounds in 2019. A chronic wound is generally defined as any wound that fails to heal within a reasonable timeframe. Chronic wounds can be categorized into the following four groups: arterial, pressure, diabetic, and venous. Despite the well-established standard of care for chronic wounds, which includes sharp debridement, offloading, and maintaining proper moisture balance, a notable gap remains between historical outcomes and desired results in chronic wound care. One approach to treating chronic wounds involves the use of dehydrated human placental tissues, 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 dHTPs 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 dHTPs includes allografts, which are human donor tissue samples intended for use in another human patient. Utilizing human amniotic membrane as an allograft displays considerable promise for chronic wound treatment.

Conditions

• Diabetic Foot Ulcer (DFU)
• Venous Leg Ulcer (VLU)
• Pressure Ulcer (PU)

Interventions

Type	Name	Description
BIOLOGICAL	dHPT, AIC	Sterile dehydrated Human Amnion - Intermediate Layer - Chorion Membrane Allograft

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-01-29
• Last updated: 2026-03-03