Foot ulcer Skin and Connective Tissue Diseases Foot ulcer
Conditions
Interventions
Current intervention as of 03/03/2022:
The NATROX® oxygen wound therapy device is a licensed battery-operated class II medical device, which via a ‘web’ shaped applicator delivers appr
Sponsors
Cumbria Partnership NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of a Foot Ulcer, present on area that is measurable with a grid sheet (this can include plantar, calcaneus, dorsal, hallux, apex, or ankle based ulcers). This includes DFU, peripheral arterial disease related wound, or other aetiology 2. No minimum chronicity applicable for the index foot ulcer 3. Adult patients aged > = 18 years 4. Patients with recurrent wounds, including multiple wounds, are eligible. The largest of the wounds, that is measurable with a grid sheet, will be selected for the trial 5. Mental capacity to give consent
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 03/03/2022: 1. Limited life expectancy, i.e. undergoing palliative care 2. Active infection in foot ulcer that cannot be managed in podiatry service (ie requires specialist secondary care intervention) 3. Ulcer penetrating the tendon, periosteum, or bone. 4. Foot ulcer in area of the foot, e.g. in between toes, which would make exact ulcer size measurement, or application of the Natrox device, impossible. 5. Pregnant, actively planning to become pregnant, or lactating (all self-reported) 6. Currently receiving intravenous antibiotics, or within one week of receiving iv antibiotics (topical and oral antibiotics are not an exclusion criterion). 7. Participating in another research study involving an investigational product that is related to the DFU or a co-morbidity that may influence wound healing (incl diabetes, peripheral arterial disease, or immune disorders). 8. Use of barrier cream/ointment and honey-based dressings (as per Natrox device instructions) 9. Concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives, or significantly impede compliance with NATROX® therapy. Previous participant exclusion criteria: 1. Limited life expectancy, i.e. undergoing palliative care 2. Active infection in foot ulcer that cannot be managed in podiatry service (ie requires specialist secondary care intervention) 3. Ulcer penetrating the tendon, periosteum or bone. 4. Foot ulcer in area of the foot, e.g. in between toes, which would make exact ulcer size measurement, or application of the Natrox device, impossible. 5. Pregnant, actively planning to become pregnant, or lactating (all self-reported) 6. Currently receiving intravenous antibiotics, or within one week of receiving iv antibiotics (topical and oral antibiotics are not an exclusion criterion). 7. Participating in another research study involving an investigational product that is related to the DFU or a co-morbidity that may influence wound healing (incl diabetes, peripheral arterial disease, or immune disorders). 8. Concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives, or significantly impede compliance with NATROX® therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Natrox arm only: Participants’ experience of and compliance with Natrox oxygen therapy is measured using a bespoke questionnaire at 12 weeks. Assessed at the end of the study: 2. Recruitment and attrition rates, willingness of patients to consent and to be randomised, response rates to questionnaires, and degrees of missing data 3. Testing of eligibility criteria and ability/willingness of clinical staff to partake in recruitment and follow-up of participants 4. Adequacy of duration of follow-up (e.g. in relation to foot ulcer healing) as measured by the number of appointments made for and attended by the patient relating to the foot ulcer 5. Appropriateness of inclusion/exclusion criteria and outcomes measures (both clinical and patient-reported) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 03/03/2022: 1. Clinical characterisation of the wound -- including clinical opinion of infection (none, possible, infected), erythema (none, slight, significant), purulence (none, slight, significant), and odour (none, low, moderate, high) – is completed at the start of the screening period (-4 weeks), baseline, 3, 6, 9, and 12 weeks 2. Ulcer size is measured by Coloplast grid or suitable equivalent at the start of the screening period (-4 weeks), baseline, 3, 6, 9, and 12 weeks 3. Ulcer severity is measured by the Pressure Ulcer Scale for Healing (PUSH) at the start of the screening period (-4 weeks), baseline, 3, 6, 9, and 12 weeks 4. DFU ulcers only: diabetic ulcer severity is measured by the Site, Ischemia, Neuropathy, Bacterial Infection, and Depth (SINBAD) classification system at the start of the screening period (-4 weeks), baseline, 3, 6, 9, and 12 weeks 5. Wound closure status in terms of healed, not healed, or recurrence is recorded at the start of the screening period (-4 weeks), baseline, 3, 6, 9, and 12 weeks 6. Quality of life is measured using two tools -- the Cardiff Wound Impact Questionnaire (CWIQ) and the EQ-5D-5L -- at baseline, 6, and 12 weeks 7. Safety of applied oxygen therapy in comparison to standard care arm is an ongoing outcome measure and is quantified by wound infection incidence and need for secondary interventions, such as surgery Previous secondary outcome measures as of 17/08/2021: 1. Clinical characterisation of the wound -- including clinical opinion of infection (none, possible, infected), erythema (none, slight, significant), purulence (none, slight, significant), and odour (none, low, moderate, high) – is completed at the start of the screening period (-4 weeks), baseline, 3, 6, 9, and 12 weeks 2. Ulcer size is measured by Colop | — |
Countries
England, United Kingdom
Contacts
Public ContactKatie Boichat
Outcome results
None listed