The clinical trial will assess the delivery of Nitric Oxide topically to the diabetic foot ulcer wound and the surrounding wound area as it related to wound healing. The objective of the study is to assess the Nitric Oxide Therapy treatment time (the number of minutes to deliver the treatment) and frequency (number of days per week to treat) to determine the most optimal treatment time and frequency to develop a rationale for safety and efficacy for the final APT001 clinical study.
APT001 is a medical device that generates nitric oxide (NO) from ambient room air within a defined plasma stream. This study is a randomized, prospective, multi-center feasibility study that will assess the effect of Nitric Oxide treatment time (minutes) and frequency (days/week) on wound healing in adults with diabetic foot ulcers (DFUs) and to provide information that will be used to develop final safety and effectiveness hypotheses for a pivotal trial of the APT001 device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Enrollment
100
Standard of Care arm which includes wound care, dressings and debridement.
Active Therapy Nitric Oxide delivered topically to the wound twice a week for 6 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
Active Therapy Nitric Oxide delivered topically to the wound twice a week for 12 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
Clinical Site
Montgomery, Alabama, United States
RECRUITINGClinical Site
Phoenix, Arizona, United States
Wound Closure rate
cm2 of epithelium coverage per week
Time frame: 12 weeks of treatment
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Active Therapy Nitric Oxide delivered topically to the wound four times a week for 6 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
Active Therapy Nitric Oxide delivered topically to the wound four times a week for 12 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
Clinical Site
Tucson, Arizona, United States
RECRUITINGClinical Site
Fresno, California, United States
RECRUITINGClinical Site
Los Angeles, California, United States
RECRUITINGClinical Site
San Francisco, California, United States
RECRUITINGClinical Site
Sylmar, California, United States
RECRUITINGClinical Site
Cooper City, Florida, United States
RECRUITINGClinical Site
Miami, Florida, United States
RECRUITINGClinical Site
Miami, Florida, United States
RECRUITING...and 5 more locations