Clinical trial NCT03078933: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: DFU
Lead sponsor: Origin Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Two or more interventions, each alone and in combination, are evaluated in parallel against a control group
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Wound Closure rate
timeFrame: 12 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Clinical Site
state: Alabama
city: Phoenix
country: United States
facility: Clinical Site
state: Arizona
city: Tucson
country: United States
facility: Clinical Site
state: Arizona
city: Fresno
country: United States
facility: Clinical Site
state: California
city: Los Angeles
country: United States
facility: Clinical Site
state: California
city: San Francisco
country: United States
facility: Clinical Site
state: California
city: Sylmar
country: United States
facility: Clinical Site
state: California
city: Cooper City
country: United States
facility: Clinical Site
state: Florida
city: Miami
country: United States
facility: Clinical Site
state: Florida
city: Miami
country: United States
facility: Clinical Site
state: Florida
city: Boston
country: United States
facility: Clinical Site
state: Massachusetts
city: West Columbia
country: United States
facility: Clinical Site
state: South Carolina
city: Corpus Christi
country: United States
facility: Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Site
state: Texas
city: Webster
country: United States
facility: Clinical Site
state: Texas
Study officials:
affiliation: Origin Inc.
name: David Dantzker, MD
role: STUDY_CHAIR
affiliation: Institute for Advanced Wound Care
name: Terry Treadwell, MD
role: PRINCIPAL_INVESTIGATOR
References: