NCT07291817 Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study
| NCT ID | NCT07291817 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lo Zhiwen Joseph |
| Condition | Diabetic Foot Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-11-03 |
| Primary Completion | 2026-11-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-11-03 with a primary completion date of 2026-11-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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 \<70 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.
Contact & Investigator
Zhiwen Joseph Lo
PRINCIPAL INVESTIGATOR
Woodlands Health
Frequently Asked Questions
Who can join the NCT07291817 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 99 Years, studying Diabetic Foot Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07291817 currently recruiting?
Yes, NCT07291817 is actively recruiting participants. Visit ClinicalTrials.gov or contact Lo Zhiwen Joseph to inquire about joining.
Where is the NCT07291817 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT07291817 clinical trial?
NCT07291817 is sponsored by Lo Zhiwen Joseph. The principal investigator is Zhiwen Joseph Lo at Woodlands Health. The trial plans to enroll 30 participants.