Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study (NCT07291817) | Clinical Trial Compass
RecruitingNot Applicable
Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study
Singapore30 participantsStarted 2025-11-03
Plain-language 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.
Who can participate
Age range
21 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of signed and dated informed consent form
. Stated willingness to comply with all study procedures and availability for the duration of the study
. Male or female, aged 21-99.
. Diagnosed with diabetes mellitus.
. Toe systolic pressure \<90 mmHg on the leg to be treated (after revascularization)
. Open chronic wound on the foot
. Ability to operate the treatment device, and willing to adhere to the study intervention regimen.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.