ANODE study
Research type
Research Study
Full title
Prospective, multicenter evaluation of the application of NATROX® topical oxygen therapy in patients with chronic and delayed healing foot ulcers.
IRAS ID
262187
Contact name
Katie Boichat
Contact email
Sponsor organisation
Cumbria Partnership NHS Foundation Trust
Clinicaltrials.gov Identifier
CP1903, CP1903
Duration of Study in the UK
1 years, 1 months, 30 days
Research summary
Diabetic foot ulcers (DFU) can lead to infection and further deterioration to health. They are a considerable burden to both the NHS and the patient. Clinicians have the option to treat the wound conservatively or more aggressively with oxygen. At present there is a lack of data available to aid clinicians in deciding what approach is best. The NATROX® oxygen wound therapy device is a licensed battery-operated class II medical device, which via a ‘web’ shaped applicator delivers approximately 15 ml of oxygen per hour to the wound. Thus far, published data suggests that the Natrox device is capable of healing chronic delayed-healing foot wounds, typically present for over a year, by more than 50% over a treatment period of 8 weeks. However, there is a lack of evidence on how the device is perceived by patients who use it, i.e. acceptability of the device, and compliance rates. Furthermore, the impact of oxygen therapy on the make-up of the type of bacteria in the wound has also not been investigated in detail. Twenty patients, recruited from two NHS Trusts, will be enrolled in a real-world evaluation study. Patients will be eligible for Natrox therapy if, according to standard practice, their wound has not healed by at least 50% in the four weeks prior. Clinical (wound status) and patient-reported outcome measures will be collated at baseline, and periodically up to 12 weeks. The wound-related costs, including staffing, clinics, dressings and diagnostics will be included in this analysis. Since the Natrox device is already CE-marked, it can be incorporated in standard wound care practice across the UK without the need for regulatory delays and with minimal need for staff training. However, this is provided Natrox proves to be effective, safe, and cost-effective.
REC name
West of Scotland REC 1
REC reference
19/WS/0071
Date of REC Opinion
13 May 2019
REC opinion
Unfavourable Opinion