A Feasibility Study of Advance Plasma Therapy001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Podiatry, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 22 - 85 |
| Updated: | 3/24/2017 |
| Start Date: | March 20, 2017 |
| End Date: | July 2018 |
| Contact: | Katherine M Tranotti, BSN/MBA |
| Email: | ktranotti@originww.com |
| Phone: | 6092506000 |
A Randomized, Prospective, Multi-Center Feasibility Study of APT001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
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.
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.
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.
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.
Inclusion Criteria:
- Diabetes Type 1 or Type 2
- Wound size greater than or equal to 1 cm2 and less than or equal to 16 cm 2
- 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
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