NCT02356835

APT001 Plasma/NO Generator to Treat Diabetic Foot Ulcer in Adults

A Pivotal Study of the Use of Nitric Oxide / Plasma Therapy as Produced by the APT001 Plasma / Nitric Oxide Generator in Adult Subjects With a Diabetic Foot Ulcer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Origin Inc. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a 10-week, randomized, controlled study to evaluate the efficacy and safety of the APT001 plasma and nitric oxide treatment in subjects with a diabetic foot ulcer.

Detailed description

Approximately 80 subjects will be randomized by computer to receive equally either sham therapy or plasma / nitric oxide treatments topically. The nitric oxide / plasma treatment will be delivered from 11.5 to 15 centimeters from the wound surface for 10 seconds per cm2 of wound size. Subjects will be evaluated for efficacy and safety on a regular basis with clinical observations. The wounds of both groups will be treated with sharp debridement as determined by the site Investigator. A collagen dressing, a non-adherent dressing, and an absorptive dressing will be applied to the wound after either the study therapy or the sham therapy. For an initial safety evaluation in patients with DFU, the first ten patients randomized will be limited to wound size of 7 cm2 or less and their wounds will be assessed 2-4 days after each treatment session. Following completion of the final assessment in these 10 patients, data will be submitted to FDA for review and approval before opening the enrolment for the remaining patients.

Conditions

• Foot Ulcer, Diabetic

Interventions

Type	Name	Description
DEVICE	APT001	APT001, is a portable device that uses plasma energy to deliver nitric oxide to the tissues.
DEVICE	SHAM	Portable device that uses warmed room air to mimic delivery of the APT001 treatment.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-01-01
• Completion: 2016-03-01
• First posted: 2015-02-05
• Last updated: 2016-03-17

Locations

4 sites across 1 country: United States