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

Not Applicable

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: Nitric Oxide Therapy 4x week 6 min. plus standard of care; Device: Nitric Oxide Therapy 2x week 12 min. plus standard of care; Device: Nitric Oxide Therapy 4x week 12 min. plus standard of care; Device: Standard of Care; Device: Nitric Oxide Therapy 2x week 6 min. plus standard of care

• Registration Number: NCT03078933
• Lead Sponsor: Origin Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-14
• Study Start: 2017-03-20
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-05
• Last Update Posted: 2017-06-07
• Primary Completion: 2018-05
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
APT001Nitric Oxide tx 4x week 6 min+SOC	Nitric Oxide Therapy 4x week 6 min. plus standard of care	APT001 Nitric Oxide Therapy 4x week for 6 min. treatment time plus standard of care
APT001Nitric Oxide tx 2x week 12 min+SOC	Nitric Oxide Therapy 2x week 12 min. plus standard of care	APT001Nitric Oxide Therapy 2x week for 12 min. treatment time plus standard of care
APT001Nitric Oxide tx 4x week 12 min+SOC	Nitric Oxide Therapy 4x week 12 min. plus standard of care	APT001Nitric Oxide Therapy 4x week for 12 min. treatment time plus standard of care
Standard of Care	Standard of Care	Standard of care for diabetic foot ulcer wound care
APT001NitricOxide tx 2x week 6 min+ SOC	Nitric Oxide Therapy 2x week 6 min. plus standard of care	APT001 Nitric OxideTherapy 2x week for 6 min. treatment time plus standard of care

Primary Outcome Measures

Name	Time	Method
Wound Closure rate	12 weeks of treatment	cm2 of epithelium coverage per week

Trial Locations

Locations (1)

Clinical Site; 🇺🇸 Webster, Texas, United States