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

Origin Inc.

Status: Unknown

Conditions: Diabetic Foot Ulcer

Treatments: Device: Nitric Oxide Therapy 2x week 6 min. plus standard of care; Device: Standard of Care; Device: Nitric Oxide Therapy 4x week 12 min. plus standard of care; Device: Nitric Oxide Therapy 4x week 6 min. plus standard of care; Device: Nitric Oxide Therapy 2x week 12 min. plus standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT03078933

ORI-16-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 22 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

100 participants in 5 patient groups

Standard of Care

Active Comparator group

Description:

Standard of care for diabetic foot ulcer wound care

Treatment:

Device: Standard of Care

APT001NitricOxide tx 2x week 6 min+ SOC

Experimental group

Description:

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

Treatment:

Device: Nitric Oxide Therapy 2x week 6 min. plus standard of care

APT001Nitric Oxide tx 2x week 12 min+SOC

Experimental group

Description:

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

Treatment:

Device: Nitric Oxide Therapy 2x week 12 min. plus standard of care

APT001Nitric Oxide tx 4x week 6 min+SOC

Experimental group

Description:

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

Treatment:

Device: Nitric Oxide Therapy 4x week 6 min. plus standard of care

APT001Nitric Oxide tx 4x week 12 min+SOC

Experimental group

Description:

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

Treatment:

Device: Nitric Oxide Therapy 4x week 12 min. plus standard of care