A Feasibility Study of Advance Plasma Therapy001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers

A Randomized, Prospective, Multi-Center Feasibility Study of APT001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers

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.

Inclusion Criteria:

• Diabetes Type 1 or Type 2
• Wound size greater than or equal to 1 cm2 and less than or equal to 16 cm2
• HbA1c less than or equal to 12 %
• Single full thickness DFU on the plantar aspect of toes or foot
• Ankle Brachial Index greater than or equal to 0.7

Exclusion Criteria:

• Infection of the ulcer
• Active Charcot's disease
• wound involves deeper tissues including bone or tendon
• Negative pressure therapy on affected foot or Hyperbaric Oxygen Therapy