Pilot Study of PHOENIX Impact on Wound Microbiome

A Pilot Study to Determine the Impact of the 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

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: PHOENIX Wound Matrix

Detailed Description

The PHOENIX Wound Matrix® (PHOENIX) is a novel, fully synthetic, fully 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. As PHOENIX degrades, the pH of the local wound environment is lowered.

In this pilot study, the investigators will examine the microbiome of chronic diabetic foot ulcers from ten subjects prior to treatment with PHOENIX Wound Matrix® (PHOENIX) and one week following treatment with PHOENIX.

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Sally Kaplan, RN CCRC; Phone Number: 516-233-3600; Email: skaplan2@northwell.edu

Study Locations

• United States
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Health Comprehensive Wound Care Center
      • Contact: Sally Kaplan, RN CCRC; Phone Number: 516-233-3600; Email: skaplan2@northwell.edu
      • Principal Investigator: Alisha Oropallo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with a DFU non-responsive to standard of care for a minimum of treatment period of 28 days.

Description

Inclusion Criteria:

1. Informed Consent Form is signed and dated prior to any study-related activities.
2. 18 years of age or older.
3. Type 1 or type 2 diabetes mellitus.
4. Negative serum pregnancy test at screening for female participants of child-bearing potential.

5. At least one DFU that meet the following criteria:

   1. Ulcer was diagnosed as a partial- or full-thickness DFU that is located distal to the malleolus (excluding ulcers between the toes but including those of the heel)
   2. Minimum 2-cm margin between the qualifying study ulcer and any other ulcers on the specified foot (post-debridement).
   3. 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.
   4. Duration of the study ulcer is a minimum of 4 weeks at the time of the study Visit 1.
   5. Study ulcer has no clinical features of infection - no elevated bacterial or fungal load, nor at least 2 of the following: pain, redness, purulence, swelling, warmth.

Exclusion Criteria:

1. 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.
2. Positive serum pregnancy test at screening for female participants of child-bearing potential.
3. Previous treatment with PHOENIX Wound Matrix.
4. Participation in another clinical trial involving a device or systematically administered investigational study drug or treatment within 30 days of Visit 1 of this Study.
5. 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.
6. History of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or chemotherapy within the 12 months prior to randomization.
7. Treatment with wound dressings that include growth factors, engineered tissues, or skin substitutes within 30 of Study Visit 1 or scheduled to receive such treatment during the Study.
8. Edema or lymphedema non-responsive to the standard of care.
9. Treatment with hyperbaric oxygen within 5 days of screening or scheduled to receive this treatment during the Study
10. 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.)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pilot Group; Ten subjects with a DFU non-responsive to standard of care for a minimum of treatment period of 28 days.	Device: PHOENIX Wound Matrix; PHOENIX Wound Matrix will be applied to each subject's DFU following debridement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Microbiome	Analysis of the wound microbiome in subjects with chronic DFUs prior to PHOENIX application and 1 week post PHOENIX application: This analysis will identify and quantify the bacterial and fungal microorganisms present in the wound bed.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound pH	Analysis of the wound bed pH prior to PHOENIX application and 1 week post PHOENIX application.	1 week

Collaborators and Investigators

• Sponsor: RenovoDerm
• Collaborators: Northwell Health; University of Wisconsin, Madison
• Investigators: Principal Investigator: Alisha Oropallo, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2022
• Primary Completion (Anticipated): August 15, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: May 23, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Diabetic Foot Ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: PWMDFUMB2020-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes