Topical Oxygen and Diabetic Foot Ulcers 2

Completed

• Conditions: Patients with diabetic foot ulcers present for more than 4 weeks; Nutritional, Metabolic, Endocrine; Diabetic foot ulcer

• Registration Number: ISRCTN13815433
• Lead Sponsor: Inotec AMD

Brief Summary

2017 preliminary results in conference proceedings http://www.jvascsurg.org/article/S0741-5214(17)31652-X/abstract

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-08
• Study Completion: 2018-09-30
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

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 < 50% healed in 4 weeks (the use of negative pressure wound therapy to optimise wound bed is allowable)
3. 2 weeks of standard of care at the hospital based diabetic foot clinic or in a specialist community diabetic podiatry
clinic prior to randomisation or entry into the open registry
4. No planned future revascularisation (endovascular or open surgery) or randomisation within 4 weeks following
revascularisation being performed
5. Ongoing active chemical or sharp wound debridement prior to, and during, the application of Natrox™
6. No limit on level of ischaemia, either high or low. The extent of arterial disease will be documented by angiogram or
duplex ultrasound and toe blood pressure. The extent of the disease will be documented using the Bollinger score.
7. The subject is 18 years of age or older
8. The patient is willing to complete >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

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 <1 year
5. Subjects with an ulcer which is <0.5 cm2 or >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in wound size at 12 weeks relative to the baseline measurement

Secondary Outcome Measures

Name	Time	Method
<br> 1. Absolute closure numbers during the 24-week follow-up period<br> 2. Wound closure rate on a per protocol basis during the 24-week follow-up period<br> 3. Number of infective episodes during the 24-week follow-up period<br> 4. Number of dressing episodes during the 24-week follow-up period<br> 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<br> 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<br> 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<br>