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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Standard of Care
* Device: Nitric Oxide Therapy 2x 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 6 min. plus standard of care
* Device: Nitric Oxide Therapy 4x week 12 min. plus standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Two or more interventions, each alone and in combination, are evaluated in parallel against a control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Standard of care for diabetic foot ulcer wound care | Device: Standard of Care<br>* Standard of Care arm which includes wound care, dressings and debridement.<br>|
| Experimental: APT001NitricOxide tx 2x week 6 min+ SOC<br>APT001 Nitric OxideTherapy 2x week for 6 min. treatment time plus standard of care | Device: Nitric Oxide Therapy 2x week 6 min. plus standard of care<br>* 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.<br>|
| Experimental: APT001Nitric Oxide tx 2x week 12 min+SOC<br>APT001Nitric Oxide Therapy 2x week for 12 min. treatment time plus standard of care | Device: Nitric Oxide Therapy 2x week 12 min. plus standard of care<br>* 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.<br>|
| Experimental: APT001Nitric Oxide tx 4x week 6 min+SOC<br>APT001 Nitric Oxide Therapy 4x week for 6 min. treatment time plus standard of care | Device: Nitric Oxide Therapy 4x week 6 min. plus standard of care<br>* 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.<br>|
| Experimental: APT001Nitric Oxide tx 4x week 12 min+SOC<br>APT001Nitric Oxide Therapy 4x week for 12 min. treatment time plus standard of care | Device: Nitric Oxide Therapy 4x week 12 min. plus standard of care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Closure rate | cm2 of epithelium coverage per week | 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DFU