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

June 5, 2017 updated by: Origin Inc.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36111
        • Recruiting
        • Clinical Site
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Recruiting
        • Clinical Site
      • Tucson, Arizona, United States, 85634
        • Recruiting
        • Clinical Site
    • California
      • Fresno, California, United States, 93721
        • Recruiting
        • Clinical Site
      • Los Angeles, California, United States, 90001
        • Recruiting
        • Clinical Site
      • San Francisco, California, United States, 94115
        • Recruiting
        • Clinical Site
      • Sylmar, California, United States, 91342
        • Recruiting
        • Clinical Site
    • Florida
      • Cooper City, Florida, United States, 33024
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33031'
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33032
        • Recruiting
        • Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Clinical Site
    • South Carolina
      • West Columbia, South Carolina, United States, 29033
        • Recruiting
        • Clinical Site
    • Texas
      • Corpus Christi, Texas, United States, 78401
        • Recruiting
        • Clinical Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Clinical Site
      • Webster, Texas, United States, 78245
        • Recruiting
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Standard of care for diabetic foot ulcer wound care
Device: Standard of Care
Standard of Care arm which includes wound care, dressings and debridement.
Experimental: APT001NitricOxide tx 2x week 6 min+ SOC
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
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.
Experimental: APT001Nitric Oxide tx 2x week 12 min+SOC
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
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.
Experimental: APT001Nitric Oxide tx 4x week 6 min+SOC
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
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.
Experimental: APT001Nitric Oxide tx 4x week 12 min+SOC
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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Origin Inc.

Investigators

  • Principal Investigator: Terry Treadwell, MD, Institute for Advanced Wound Care
  • Study Chair: David Dantzker, MD, Origin Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2017

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

February 28, 2017

First Submitted That Met QC Criteria

March 8, 2017

First Posted (Actual)

March 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 5, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORI-16-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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