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

NCT04437537 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-01-16

No results posted yet for this study

Summary

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

Conditions

  • Diabetic Foot Ulcer

Interventions

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.

Sponsors & Collaborators

  • Simon Tabchi DPM, PA Foot & Ankle Associates

    collaborator UNKNOWN
  • Lindsay Kalan PhD, Kalan Lab, McMaster University

    collaborator UNKNOWN
  • RenovoDerm

    lead INDUSTRY

Principal Investigators

  • Simon G Tabchi, DPM · PA Foot & Ankle Associates

  • Lindsay Kalan, PhD · Kalan Lab, McMasters University

  • Elsa Englund Kayuha, MD · RenovoDerm

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-21
Primary Completion
2025-07-21
Completion
2025-07-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04437537 on ClinicalTrials.gov