Intermittent negative pressure therapy for diabetic foot ulcers (INPRESS)
Official title: Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study
Run by Woodlands Hospital · NCT07291817 · Data updated 2026-11-12
This study will test whether using the FlowOx device for one hour in the morning and one hour in the evening for 12 weeks can raise toe blood pressure and reduce wound size in adults with diabetic foot ulcers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 99 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Woodlands Hospital Government |
| Locations | 1 site (Singapore) |
| Status | Recruiting |
| Started | November 3, 2025 |
| Main results expected | November 2, 2026 |
| Study ends | November 2, 2026 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT07291817 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 21–99 with diabetes, an open chronic foot wound, toe systolic pressure below 70 mmHg on the affected leg after revascularization, ability to operate the device, and suitability for diabetic limb salvage.
✕Probably not a fit
Patients who are pregnant, cognitively impaired, allergic to device components, unable to operate the device, recently treated with another investigational therapy, or not suitable for limb salvage may not receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants with diabetes and a chronic open foot wound will have baseline toe systolic pressure and wound area measured and receive training on a loaned FlowOx device. They will use the device at home for one hour twice daily for 12 weeks, with a phone check at one week and clinic visits at week 6 and week 12 for repeat measurements. The main outcomes are change in toe arterial (systolic) pressure and wound surface area compared with baseline. Safety and device tolerability will also be monitored throughout the treatment period.
Why it matters
Potential benefit: If successful, the device could improve local blood flow and speed wound healing, lowering the risk of limb loss.
How similar studies have gone: Smaller and preliminary studies of intermittent negative pressure or related devices have shown promising signals for improved perfusion and wound healing, but large randomized evidence is still limited.
Who can join: the full rules
Show full inclusion / exclusion 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 \<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.
Where it's running
-
Woodlands Health
Singapore, Singapore Recruiting
Study contacts
- Principal investigator: Zhiwen Joseph Lo — Woodlands Health
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.