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

NCT04437537 | Completed FDA Device

• 1 other identifier: RD2025-001.MB
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

chronic diabetic foot ulcer; microbiome; PHOENIX Wound Matrix

Outcome Measures

Primary Outcomes (1)

• Wound Microbiome

  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.

  From enrollment to the end of Study Visit 5 (4 weeks)

Secondary Outcomes (2)

• Wound Biomarkers

  From enrollment to the completion of Study Visit 5 (4 weeks)

• Wound Bed pH

  From enrollment to completion of Study Visit 5 (4 weeks)

Study Arms (1)

Phoenix Wound Matrix plus standard of care

EXPERIMENTAL

All subjects in this pilot study will receive Phoenix Wound Matrix in addition to the standard of care treatment for their diabetic foot ulcer.

Device: Bioresorbable 3D electrospun synthetic matrix

Interventions

Bioresorbable 3D electrospun synthetic matrix DEVICE

All participants in this study will receive PHOENIX Wound Matrix® in addition to the SOC treatment for their chronic DFU.

Also known as: PHOENIX Wound Matrix®

Phoenix Wound Matrix plus standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is able and willing to provide consent, and Informed Consent Form is signed and dated prior to the initiation of any study-related activities.
• years of age or older.
• Type 1 or type 2 diabetes mellitus.
• At least one DFU that meet the following criteria:
• Ulcer is diagnosed as a partial- or full-thickness DFU located on the anatomical foot, defined as a minimum of 50% of ulcer area extending distal to the medial malleolus, excluding ulcers between the toes but including those of the heel.
• Wound surface area is ≥ 1 cm2 and ≤ 25 cm2 post-debridement at the time of Study Visit 1.
• Duration of the study ulcer will be a minimum of 4 weeks and no longer than 52 weeks at the time of the Study Visit 1.
• In the case of multiple ulcers, the largest ulcer meeting the study criteria will be designated the index ulcer and the only one included in the study. If other ulcerations are present on the same leg, there must be a margin of ≥ 2 cm between the index ulcer and all other ulcers, post-debridement.
• Wagner grade 1 or 2; or Wagner grade 3 with resolved abscess or osteomyelitis (confirmed by plain x-ray, bone biopsy, magnetic resonance imaging or bone scan) or resolved joint sepsis.
• Adequate vascular perfusion of the affected limb, confirmed by normal ankle pulses (posterior tibial and dorsalis pedis arteries). If pulse character is abnormal, ABI is required. Acceptable ABI results are ≤ 6 months old and must be within the specified range to qualify: 0.8 \< ABI \< 1.2.
• Subject is willing and able to comply with offloading (as applicable for the location of the ulcer) or with use of appropriate footwear, as specified by the Investigator.
• Subject is willing and able to comply with the requirements of this study, as instructed by the Investigator in accordance with the study protocol.

You may not qualify if:

• Presence of signs and symptoms of infection at the index ulcer site or affected limb, including but not limited to cellulitis, osteomyelitis, excessive exudate, gangrene or deep tissue infection at the time of Study Visit 1.
• Presence of diabetes with poor metabolic control as documented with an HbA1c ≥ 12.0 within 3 months of Study Visit 1.
• Continued use of systemic antibiotics or use of systemic antibiotics within 7 days of Study Visit 1.
• Females of childbearing potential.
• Previous treatment with PHOENIX Wound Matrix®.
• Participation in another clinical trial involving a device or systematically administered investigational study drug or treatment within 30 days of Study Visit 1 date.
• Receiving or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with, or affect, the rate and quality of wound healing.
• History of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or chemotherapy within the 12 months of Study Visit 1 date.
• Treatment with wound dressings that include growth factors, engineered tissues, or skin substitutes within 30 days of Study Visit 1, or scheduled to receive such treatment during the Study.
• Edema or lymphedema non-responsive to the standard of care.
• Treatment with hyperbaric oxygen within 5 days of Study Visit 1 or scheduled to receive this treatment during the Study.
• History of or intercurrent illnesses or conditions (other than diabetes) that would compromise the safety of the subject, or the normal wound healing process (i.e., end stage renal disease, immunosuppression, AIDS, bleeding disorders, etc.).

Sponsors & Collaborators

• RenovoDerm: lead
• Simon Tabchi DPM, PA Foot & Ankle Associates: collaborator
• Lindsay Kalan PhD, Kalan Lab, McMaster University: collaborator

Study Sites (1)

PA Foot & Ankle Associates

Northampton, Pennsylvania, 18067, United States

Location

Related Publications (5)

• A.G. Neto, R.A. Hickman, A. Khan, C. Nossa, Z. Pei, Chapter 1 - The Upper Gastrointestinal Tract-Esophagus and Stomach, Editor(s): Martin H. Floch, Yehuda Ringel, W. Allan Walker, The Microbiota in Gastrointestinal Pathophysiology, Academic Press, 2017, Pages 1-11, ISBN 9780128040249, https://doi.org/10.1016/B978-0-12-804024-9.00001-X.

  BACKGROUND

• Kalan L, Grice EA. Fungi in the Wound Microbiome. Adv Wound Care (New Rochelle). 2018 Jul 1;7(7):247-255. doi: 10.1089/wound.2017.0756.

  PMID: 29984114 BACKGROUND

• Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.

  PMID: 19478181 BACKGROUND

• Ursell LK, Metcalf JL, Parfrey LW, Knight R. Defining the human microbiome. Nutr Rev. 2012 Aug;70 Suppl 1(Suppl 1):S38-44. doi: 10.1111/j.1753-4887.2012.00493.x.

  PMID: 22861806 BACKGROUND

• Proctor LM. The Human Microbiome Project in 2011 and beyond. Cell Host Microbe. 2011 Oct 20;10(4):287-91. doi: 10.1016/j.chom.2011.10.001.

  PMID: 22018227 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Simon G Tabchi, DPM

  PA Foot & Ankle Associates

  PRINCIPAL INVESTIGATOR

• Lindsay Kalan, PhD

  Kalan Lab, McMasters University

  PRINCIPAL INVESTIGATOR

• Elsa Englund Kayuha, MD

  RenovoDerm

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: June 18, 2020
• Study Start: March 21, 2025
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)