Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study

Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study

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.

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.