Patients with diabetic foot ulcers present for more than 4 weeks Nutritional, Metabolic, Endocrine Diabetic foot ulcer
Conditions
Interventions
All subjects who are screened will be divided into two groups.
Group 1 – subjects with diabetic foot ulcers between 4 weeks and 6 months
Subjects are blinded into two
Sponsors
Inotec AMD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A diabetic foot ulcer greater than 4 weeks and less than 6 months in duration for group 1 and greater than 6 months in duration for group 2 2. Minor amputation sites 75% of follow-up evaluations required by the study protocol 9. The patient is able to abstain from any other treatment of the ulcer for the duration of the study, which would fall outside the normal standard care for a DFU, unless medically necessary 10. The patient agrees to abstain from enrolment in any other clinical trial for the duration of the study 11. The patient is able to read and understand instructions and give voluntary written informed consent 12. The patient is able and willing to follow the protocol requirements
Exclusion criteria
Exclusion criteria: 1. Inability to comply with dressing regime or manage the Natrox™ device 2. Absolute need for a total contact cast 3. Disseminated malignancy 4. Subjects with a life expectancy 50 cm2 6. Subject who is dialysis dependent 7. The subject has an invasive soft tissue infection at the time of baseline assessment, requiring oral or intravenous antibiotic therapy 8. Exposed bone without soft tissue or granulation tissue across the surface 9. Acute osteomyelitis (stable, chronic osteomyelitis is allowable, including those maintained on oral antibiotics, as long as there is no planned surgical intervention) 10. Subject being treated with immunosuppressive medication greater than 7.5 mg prednisolone daily 11. Pregnant/lactating females (self-reported or tested, per institutional requirements) 12. Glycated haemoglobin HbA1C of >12mmol mol1 13. Subjects who have evidence of connective tissue disorders (e.g., vasculitis or rheumatoid arthritis) under active treatment 14. The subject is unable to follow the protocol 15. The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety 16. The patient is a vulnerable or protected adult 17. The patient is unable to provide consent 18. DFU connected to a sinus wound 19. Wounds were it is felt clinically necessary to cover the surface in gel or creams that would prevent the transmission of oxygen to the wounds surface
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in wound size at 12 weeks relative to the baseline measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Absolute closure numbers during the 24-week follow-up period 2. Wound closure rate on a per protocol basis during the 24-week follow-up period 3. Number of infective episodes during the 24-week follow-up period 4. Number of dressing episodes during the 24-week follow-up period 5. Days of hospital treatment as a result of DFU complications after date of randomisation (extra data collection if hospitalised) during the 24-week follow-up period 6. QoL (diabetic foot ulcer scale) at the baseline visit and visits 1 to 8, 10, 12 and 14, and at the 24-week follow-up visit 7. Pain as reported by a visual analogue score at the baseline visit and visits 1 to 8, 10, 12 and 14, and 24-week follow-up | — |
Countries
United Kingdom
Contacts
Public ContactPaul Hayes
Outcome results
None listed