Pilot Study of PHOENIX Impact on Wound Microbiome

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04437537
• Other study ID #: PWMDFUMB2020-1
• Status: Not yet recruiting
• Start date: May 15, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: October 2021
• Source: Nanofiber Solutions
• Contact: Sally Kaplan, RN CCRC
• Phone: 516-233-3600
• Email: skaplan2[@]northwell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 1, 2023
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• PHOENIX Wound Matrix
PHOENIX Wound Matrix will be applied to each subject's DFU following debridement.

Locations

Country	Name	City	State
United States	Northwell Health Comprehensive Wound Care Center	Lake Success	New York

Sponsors (3)

Lead Sponsor	Collaborator
RenovoDerm	Northwell Health, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wound pH	Analysis of the wound bed pH prior to PHOENIX application and 1 week post PHOENIX application.	1 week