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

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: PHOENIX Wound Matrix

• Registration Number: NCT04437537
• Lead Sponsor: RenovoDerm

Brief 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.

Study Timeline

• Study First Submitted: 2020-05-23
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-18
• Study Start: 2025-03-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pilot Group	PHOENIX Wound Matrix	Ten subjects with a DFU non-responsive to standard of care for a minimum of treatment period of 28 days.

Primary Outcome Measures

Name	Time	Method
Wound Microbiome	From enrollment to the end of Study Visit 5 (4 weeks)	Analysis of the wound microbiome in subjects with chronic DFUs prior to PHOENIX application and at follow-up Study Visits 3, and possibly 5 (if debridement is deemed necessary by the Investigator), again prior to the application of PHOENIX.; This analysis will identify and quantify bacterial and fungal microorganisms present in the wound bed.

Secondary Outcome Measures

Name	Time	Method
Wound Biomarkers	From enrollment to the completion of Study Visit 5 (4 weeks)	Wound fluid samples will be collected at Study Visits 1, 3, and possibly 5 (if debridement is required at Study Visit 5) for quantitative analysis of biomarkers of wound healing.
Wound Bed pH	From enrollment to completion of Study Visit 5 (4 weeks)	Analysis of wound bed pH will be performed at all study visits upon removal of old dressings, prior to cleansing and debridement. During study visits where debridement is perform, pH will be analyzed post-debridement as well.

Trial Locations

Locations (1)

PA Foot & Ankle Associates; 🇺🇸 Northampton, Pennsylvania, United States