Diabetic Foot Ulcer
Conditions
Brief summary
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.
Interventions
DEVICEFlowOx
12 weeks treatment with FlowOx for 1 hour twice daily for 12 weeks
Sponsors
Lo Zhiwen Joseph
Otivio AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 21-99. 4. Diagnosed with diabetes mellitus. 5. Toe systolic pressure \<90 mmHg on the leg to be treated (after revascularization) 6. Open chronic wound on the foot 7. Ability to operate the treatment device, and willing to adhere to the study intervention regimen. 8. Suitable for diabetic limb salvage
Exclusion criteria
1. Known allergic reactions to components of the INP device. 2. Treatment with another investigational intervention within the last 12 weeks prior to inclusion. 3. Pregnant women or cognitively impaired participants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in toe arterial pressure | 12 weeks | 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 |
| Change in wound surface area | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 weeks | 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 |
| Frequency of adverse events | 12 weeks | Adverse events and side effects of the treatment will be registered, so that safety assessments can be done during and after the trial. |
| Compliance (mean daily treatment time) | 12 weeks | 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. |
Countries
Singapore
Contacts
PRINCIPAL_INVESTIGATORZhiwen Joseph Lo
Woodlands Health
Outcome results
None listed