Status:
COMPLETED
An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (NATROX™) on the Rates of Healing of Chronic Diabetic Foot Ulcers
Lead Sponsor:
Singapore General Hospital
Conditions:
Diabetic Foot Ulcer
Non-healing Wound
Eligibility:
All Genders
21-90 years
Brief Summary
This study aims to evaluate the effectiveness of NATROX™ Topical Oxygen Wound Therapy for subjects with non-healing foot ulceration. Subjects will be treated with standard care for 4 weeks. If the wou...
Detailed Description
Diabetes and its attendant complications are increasing year on year. A number of macro- and micro-circulatory changes occur as a result of long standing or poorly controlled diabetes. These, often in...
Eligibility Criteria
Inclusion
- A diabetic foot ulcer greater than 12 weeks and less than 18 months in duration
- Minor amputation sites \<50% healed in 4 weeks (the use of negative pressure wound therapy to optimize the wound bed is allowable)
- 4 weeks of standard of care at the hospital based diabetic foot clinic or in a specialist community diabetic podiatry clinic prior to entry into the open registry
- No planned revascularization (endovascular or open surgery) within 4 weeks following revascularization being performed)
- Ongoing active chemical or sharp wound debridement prior to and during the application of NATROX™
- No limit on level of ischemia, either high or low. The extent of arterial disease will be documented by angiogram or duplex ultrasound and toe blood pressure
- The subject is 21 years of age or older
- The subject is willing to complete \>75% of follow-up evaluations required by the study protocol
- The subject is able to abstain from any other clinical trial for the duration of the study
- The study is able to read and understand instructions and give voluntary written informed consent
- The subject is able and willing to follow the protocol requirements
Exclusion
- Inability to comply with the dressing regime or manage the NATROX™ device
- Disseminated malignancy
- Subjects with a \>1 year life expectancy
- Subjects with an ulcer which is \<0.5cm2 or \>50cm2
- Subjects who is dialysis dependent for less than 1 year (i.e. subject is eligible for study if has CKD/ESRF and is on dialysis for \>1year)
- The subject has an invasive soft tissue infection at the time of baseline assessment, requiring oral or intravenous antibiotic therapy.
- Exposed bone without soft tissue or granulation tissue across the surface
- Acute osteomyelitis (stable, chronic osteomyelitis is allowable, including those maintained on oral antibiotics, as long as there is no planned intervention)
- Pregnant/lactating females (self-reported or tested, as per institutional requirements)
- Glycated haemoglobin HbA1C of \>12mmol mol-1
- Subject who have evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis) under active treatment
- The subject is unable to follow the protocol
- The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
- The patient is a vulnerable or protected adult
- The patient is unable to provide informed consent
- Diabetic foot ulcer is connected to a sinus wound
Key Trial Info
Start Date :
August 17 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03863054
Start Date
August 17 2018
End Date
May 31 2021
Last Update
September 27 2021
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169608