Pilot Study of PHOENIX Impact on Wound Microbiome

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

Detailed Description
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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.

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: PHOENIX Wound Matrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent Form is signed and dated prior to any study-related activities. 18 years of age or older. Type 1 or type 2 diabetes mellitus. Negative serum pregnancy test at screening for female participants of child-bearing potential. At least one DFU that meet the following criteria: 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) Minimum 2-cm margin between the qualifying study ulcer and any other ulcers on the specified foot (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. Duration of the study ulcer is a minimum of 4 weeks at the time of the study Visit 1. 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: 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. Positive serum pregnancy test at screening for female participants of child-bearing 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 Visit 1 of this Study. 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 prior to randomization. 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. Edema or lymphedema non-responsive to the standard of care. Treatment with hyperbaric oxygen within 5 days of screening 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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot Ulcer