NCT04437537

Pilot Study of PHOENIX Wound Matrix® Impact on Chronic DFU Wound Microbiome

A Pilot Study to Assess the Impact of PHOENIX Wound Matrix® on the Wound Microbiome in Chronic Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: RenovoDerm · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Pilot Study to Determine the Impact of the Phoenix Wound Matrix® on the Wound Microbiome in Chronic Diabetic Foot Ulcers

Detailed description

The PHOENIX Wound Matrix® (PHOENIX) is a novel, fully synthetic and bioabsorbable advanced wound care device that provides a temporary microenvironment to support endogenous wound healing, allowing for the regeneration of functional, native tissue in the defect space/wound bed. The human microbiome is a highly variable ecosystem comprising diverse microbiota of bacteria and fungi that vary more from one body site to another than from one individual to another, making it possible to define a "healthy microbiome core'' that occur frequently within different body sites. Perturbations of a body site's healthy microbiome core can disrupt the symbiotic relationship between host and associated microbes, resulting in pathogenicity and poor outcomes, such as chronic wounds. The primary purpose of this study is to determine if PHOENIX alters the wound-associated microbiome in patients with chronic diabetic foot ulcers (DFUs). Wound tissue and exudate samples in subjects with chronic DFUs will be collected and analyzed.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Bioresorbable 3D electrospun synthetic matrix	All participants in this study will receive PHOENIX Wound Matrix® in addition to the SOC treatment for their chronic DFU.

Timeline

• Start date: 2025-03-21
• Primary completion: 2025-07-21
• Completion: 2025-07-21
• First posted: 2020-06-18
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study