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Diabetic Foot UlcerNCT04437537

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

A study testing Bioresorbable 3D electrospun synthetic matrix in people with Diabetic Foot Ulcer, run by RenovoDerm at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Pilot Study to Determine the Impact of the Phoenix Wound Matrix® on the Wound Microbiome in Chronic Diabetic Foot Ulcers Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot Ulcer
What is being tested?
Bioresorbable 3D electrospun synthetic matrix
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
21 Mar 2025to 21 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 18 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PA Foot & Ankle Associates

    Northampton, Pennsylvania, 18067

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Bioresorbable 3D electrospun synthetic matrix
Keywords
chronic diabetic foot ulcer, microbiome, PHOENIX Wound Matrix
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bioresorbable 3D electrospun synthetic matrixDevice

    Also called PHOENIX Wound Matrix®

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

Study groups in NCT04437537
Study groupRoleWhat they receive
Phoenix Wound Matrix plus standard of careExperimentalAll subjects in this pilot study will receive Phoenix Wound Matrix in addition to the standard of care treatment for their diabetic foot ulcer.
Receives: Device: Bioresorbable 3D electrospun synthetic matrix

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  1. Wound Biomarkers

    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.

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

  2. Wound Bed pH

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2020
  2. Study start21 Mar 2025
  3. Primary completion21 Jul 2025
  4. Study completion21 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04437537
Sponsor's protocol ID
RD2025-001.MB
Status last verified
Jan 2026
First submitted
23 May 2020
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: This is a pilot study.

Publications

  • 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.

  • 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.

    PubMed 29984114

  • 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.

    PubMed 19478181

  • 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.

    PubMed 22861806

  • 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.

    PubMed 22018227

Questions about this trial

What is this clinical trial studying?

A study testing Bioresorbable 3D electrospun synthetic matrix in people with Diabetic Foot Ulcer, run by RenovoDerm at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound Microbiome (time frame: From enrollment to the end of Study Visit 5 (4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04437537, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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