ANODE study
Research type
Research Study
Full title
Prospective, multicenter, randomised controlled feasibility trial 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
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; there is randomised controlled trial data. 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-four patients, recruited from two NHS Trusts, will be enrolled in this feasibility trial. Patients will be randomised to standard care +/- Natrox therapy if 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 could 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.
Summary of Results
The ANODE study was conducted in two NHS Trusts, namely South Tyneside & Sunderland and North Cumbria Integrated Care and coincided to a large extend with the peak of the COVID19 pandemic. Despite having screened a lot of patients, particularly in North Cumbria, not many patients were willing to participate in the study (in North Cumbria 38 eligible patients declined whereas 21 consented to take part). Of the total 30 enrolled patients who entered the four-week screening phase, only 14 (8x control and 6x Natrox) entered the twelve-week trial phase. There is insufficient data to comment on the efficacy of NAtrox in relation to wound healing. Withdrawals from the trial phase study (two in control arm) and challenges seeing patients in person due to COVID19 restrictions further affect the data quality for the study. Taken together, the planned 24 patients were recruited into the ANODE study. However, poor record keeping, COVID19 restrictions and low uptake by patients meant that definitive conclusions cannot be drawn on the potential of Natrox as an adjunct treatment for diabetic foot ulcers.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
19/ES/0073
Date of REC Opinion
19 Jul 2019
REC opinion
Further Information Favourable Opinion