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

NAUnknownINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 20, 2017

Primary Completion Date

May 31, 2018

Study Completion Date

July 31, 2018

Conditions
Diabetic Foot Ulcer
Interventions
DEVICE

Standard of Care

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

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.

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.

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.

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.

Trial Locations (15)

29033

RECRUITING

Clinical Site, West Columbia

33024

RECRUITING

Clinical Site, Cooper City

33032

RECRUITING

Clinical Site, Miami

36111

RECRUITING

Clinical Site, Montgomery

78229

RECRUITING

Clinical Site, San Antonio

78245

RECRUITING

Clinical Site, Webster

78401

RECRUITING

Clinical Site, Corpus Christi

85015

RECRUITING

Clinical Site, Phoenix

85634

RECRUITING

Clinical Site, Tucson

90001

RECRUITING

Clinical Site, Los Angeles

91342

RECRUITING

Clinical Site, Sylmar

93721

RECRUITING

Clinical Site, Fresno

94115

RECRUITING

Clinical Site, San Francisco

33031'

RECRUITING

Clinical Site, Miami

02118

RECRUITING

Clinical Site, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Origin Inc.

INDUSTRY

NCT03078933 - A Feasibility Study of Advance Plasma Therapy001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers | Biotech Hunter | Biotech Hunter