Recruiting

Advance Plasma Therapy001A Feasibility Study of Advance Plasma Therapy001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers

Sponsor:

Origin Inc.

Code:

NCT03078933

Conditions

Diabetic Foot Ulcer

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Diabetic Foot Ulcer

Study ID

NCT03078933

Start date

Mar 20, 2017

Status verified date

Jun, 2017

Completion date

Jul, 2018

Anticipated

Primary completion date

May, 2018

Anticipated

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

active comparator: Standard of Care

Standard of care for diabetic foot ulcer wound care

experimental: APT001NitricOxide tx 2x week 6 min+ SOC

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

experimental: APT001Nitric Oxide tx 2x week 12 min+SOC

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

experimental: APT001Nitric Oxide tx 4x week 6 min+SOC

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

experimental: APT001Nitric Oxide tx 4x week 12 min+SOC

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

Interventions

Standard of Care

Standard of Care arm which includes wound care, dressings and debridement.

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.

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.

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.

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.

Primary outcome measure

Wound Closure rate [ Time Frame: 12 weeks of treatment ]

Central Contacts and Locations

Central contacts

Katherine M Tranotti, BSN/MBA

6092506000 ktranotti@originww.com

Peter Pelka

6092506000 ppelka@originww.com

Locations

Clinical Site

Recruiting

Montgomery, Alabama, United States, 36111

Clinical Site

Recruiting

Phoenix, Arizona, United States, 85015

Clinical Site

Recruiting

Tucson, Arizona, United States, 85634

Clinical Site

Recruiting

Fresno, California, United States, 93721

Clinical Site

Recruiting

Los Angeles, California, United States, 90001

Clinical Site

Recruiting

San Francisco, California, United States, 94115

Clinical Site

Recruiting

Sylmar, California, United States, 91342

Clinical Site

Recruiting

Cooper City, Florida, United States, 33024

Clinical Site

Recruiting

Miami, Florida, United States, 33031'

Clinical Site

Recruiting

Miami, Florida, United States, 33032

Clinical Site

Recruiting

Boston, Massachusetts, United States, 02118

Clinical Site

Recruiting

West Columbia, South Carolina, United States, 29033

Clinical Site

Recruiting

Corpus Christi, Texas, United States, 78401

Clinical Site

Recruiting

San Antonio, Texas, United States, 78229

Clinical Site

Recruiting

Webster, Texas, United States, 78245

More Information

Sponsor

Origin Inc.

Last update posted

Jun 7, 2017

Last verified

Jun, 2017

Keywords

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Origin Inc. on 2017-06-07.