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Can a suction boot heal diabetic foot wounds? new trial aims to find out

NCT ID NCT07291817

Symptom relief Sponsor: Lo Zhiwen Joseph Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study is testing a device called FlowOx that uses gentle, intermittent suction (negative pressure) on the foot to improve blood flow and help heal diabetic foot ulcers. Thirty adults with diabetes and chronic foot wounds will use the device for one hour, twice a day for 12 weeks. Researchers will measure changes in toe blood pressure and wound size to see if the treatment is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FlowOx device (intermittent negative pressure therapy)
What this could lead to
If it works, this could offer a new, non-invasive way to help heal diabetic foot ulcers and improve blood flow in the foot.
What could go wrong
This is a small, early-stage trial with only 30 participants and no control group, so results may not be conclusive. The device requires daily use for 12 weeks, and not everyone may find it easy to use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot ulcer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Woodlands Health

    RECRUITING

    Singapore, Singapore

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