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

Primary Purpose

Diabetic Foot Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
Origin Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Diabetic Foot Ulcer focused on measuring DFU

Eligibility Criteria

22 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Standard of Care

APT001NitricOxide tx 2x week 6 min+ SOC

APT001Nitric Oxide tx 2x week 12 min+SOC

APT001Nitric Oxide tx 4x week 6 min+SOC

APT001Nitric Oxide tx 4x week 12 min+SOC

Arm Description

Standard of care for diabetic foot ulcer wound care

APT001 Nitric OxideTherapy 2x week for 6 min. treatment time plus standard of care

APT001Nitric Oxide Therapy 2x week for 12 min. treatment time plus standard of care

APT001 Nitric Oxide Therapy 4x week for 6 min. treatment time plus standard of care

APT001Nitric Oxide Therapy 4x week for 12 min. treatment time plus standard of care

Outcomes

Primary Outcome Measures

Wound Closure rate
cm2 of epithelium coverage per week

Secondary Outcome Measures

Full Information

First Posted
February 28, 2017
Last Updated
June 5, 2017
Sponsor
Origin Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03078933
Brief Title
A Feasibility Study of Advance Plasma Therapy001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
Official Title
A Randomized, Prospective, Multi-Center Feasibility Study of APT001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Origin Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
DFU

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Two or more interventions, each alone and in combination, are evaluated in parallel against a control group
Masking
Investigator
Masking Description
Investigator will be blinded to photgraphs and punch biopsy results
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of care for diabetic foot ulcer wound care
Arm Title
APT001NitricOxide tx 2x week 6 min+ SOC
Arm Type
Experimental
Arm Description
APT001 Nitric OxideTherapy 2x week for 6 min. treatment time plus standard of care
Arm Title
APT001Nitric Oxide tx 2x week 12 min+SOC
Arm Type
Experimental
Arm Description
APT001Nitric Oxide Therapy 2x week for 12 min. treatment time plus standard of care
Arm Title
APT001Nitric Oxide tx 4x week 6 min+SOC
Arm Type
Experimental
Arm Description
APT001 Nitric Oxide Therapy 4x week for 6 min. treatment time plus standard of care
Arm Title
APT001Nitric Oxide tx 4x week 12 min+SOC
Arm Type
Experimental
Arm Description
APT001Nitric Oxide Therapy 4x week for 12 min. treatment time plus standard of care
Intervention Type
Device
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care arm which includes wound care, dressings and debridement.
Intervention Type
Device
Intervention Name(s)
Nitric Oxide Therapy 2x week 6 min. plus standard of care
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Nitric Oxide Therapy 2x week 12 min. plus standard of care
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Nitric Oxide Therapy 4x week 6 min. plus standard of care
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Nitric Oxide Therapy 4x week 12 min. plus standard of care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound Closure rate
Description
cm2 of epithelium coverage per week
Time Frame
12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine M Tranotti, BSN/MBA
Phone
6092506000
Ext
6006
Email
ktranotti@originww.com
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Pelka
Phone
6092506000
Ext
6007
Email
ppelka@originww.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Dantzker, MD
Organizational Affiliation
Origin Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Terry Treadwell, MD
Organizational Affiliation
Institute for Advanced Wound Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Site
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85634
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90001
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33031'
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29033
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78401
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Site
City
Webster
State/Province
Texas
ZIP/Postal Code
78245
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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