CompletedNot Applicable

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

United States11 participantsStarted 2025-03-21

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.

✕. 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.

Wound Microbiome

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

NCT IDNCT04437537

SponsorRenovoDerm

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-21

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.

✕. 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.