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

  • STATUS
    Not Recruiting
  • participants needed
    100
  • sponsor
    Origin Inc.
Updated on 21 January 2021
Clinical Site (2.4 mi away) Contact
diabetes
debridement
type 2 diabetes mellitus
nitric oxide
hemoglobin a1c
glycosylated hemoglobin
foot ulcer

Summary

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.

Description

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.

Details
Condition Diabetic Foot
Treatment Standard of Care, Nitric Oxide Therapy 2x week 6 min. plus standard of care, Nitric Oxide Therapy 2x week 12 min. plus standard of care, Nitric Oxide Therapy 4x week 6 min. plus standard of care, Nitric Oxide Therapy 4x week 12 min. plus standard of care
Clinical Study IdentifierNCT03078933
SponsorOrigin Inc.
Last Modified on21 January 2021

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