Diabetic Foot Ulcer
Conditions
Keywords
DFU
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.
Interventions
DEVICEStandard of Care
Standard of Care arm which includes wound care, dressings and debridement.
DEVICENitric 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.
DEVICENitric 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.
DEVICENitric 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.
DEVICENitric 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.
Sponsors
Origin Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Investigator)
Masking description
Investigator will be blinded to photgraphs and punch biopsy results
Intervention model description
Two or more interventions, each alone and in combination, are evaluated in parallel against a control group
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Closure rate | 12 weeks of treatment | cm2 of epithelium coverage per week |
Countries
United States
Contacts
Primary ContactKatherine M Tranotti, BSN/MBA
Backup ContactPeter Pelka
Outcome results
None listed