The aim of this trial is to investigate the safety and efficacy of 12 weeks treatment with FlowOx, for 1 hour twice daily, when used on patients with diabetic foot ulcers. The main question it aims to answer is whether treatment with FlowOx one hour in the morning and one hour in the evening for 12 weeks can improve toe arterial pressure and wound surface area compared to baseline. Participants will have baseline assessments (i.e. toe pressure measurement and wound area measurement) performed on them and training on the use of FlowOx device will be provided to them in Visit 1. Participants will be tasked to use the FlowOx device (device will be loaned to them) for 1 hour twice daily. A phone call will be conducted 1 week after Visit 1 to follow up on the medical and user-related issues. At Week 6 (Visit 2), participants will be asked to come back for toe pressure and wound area measurement. At Week 12 (Visit 3), end of treatment assessments (i.e toe pressure and wound area measurement) will be performed. Compliance data will be acquired from the FlowOx device. Their participation in the study will last for 12 weeks. Participants will be asked to use the FlowOx device for one hour, two times a day throughout the study period. They will need to visit the clinic 3 times in the course of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
12 weeks treatment with FlowOx for 1 hour twice daily for 12 weeks
Woodlands Health
Singapore, Singapore
RECRUITINGChange in toe arterial pressure
Toe systolic blood pressure is a commonly used tool to predict wound healing in patients with diabetic foot ulcers. * Tools used: Photoplethysmography (PPG) Probe/Sensor * Unit of measure: mmHg
Time frame: 12 weeks
Change in wound surface area
Change in wound surface area will be used as an indicator of treatment effect on wound healing. * Tool used: quantitative measurement of wound surface area * Unit of measure: cm2
Time frame: 12 weeks
Comparison of the primary outcomes (changes in toe arterial pressure and wound healing rate) and post diabetic limb salvage rate between a prospective cohort that is 1:1 propensity-scored matched against a retrospective cohort
The prospective cohort will be 1:1 propensity-scored matched for age, gender and WIfI \[wound, ischaemia, foot infection\] score on presentation against a retrospective cohort. Post diabetic limb salvage rate: * Tools used: Rate of patients who do not undergo major LEA * Unit of measure: 12-week limb salvage rate
Time frame: 12 weeks
Frequency of adverse events
Adverse events and side effects of the treatment will be registered, so that safety assessments can be done during and after the trial.
Time frame: 12 weeks
Compliance (mean daily treatment time)
Compliance will be recorded as mean daily treatment time (registered by the device), so that exploratory sub-group analyses on patients with a certain compliance level may be performed.
Time frame: 12 weeks
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