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

December 4, 2025 updated by: Lo Zhiwen Joseph

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with FlowOx
Device: FlowOx
12 weeks treatment with FlowOx for 1 hour twice daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in toe arterial pressure
Time Frame: 12 weeks

Toe systolic blood pressure is a commonly used tool to predict wound healing in patients with diabetic foot ulcers.

  • Tools used: Photoplethysmography (PPG) Probe/Sensor
  • Unit of measure: mmHg
12 weeks
Change in wound surface area
Time Frame: 12 weeks

Change in wound surface area will be used as an indicator of treatment effect on wound healing.

  • Tool used: quantitative measurement of wound surface area
  • Unit of measure: cm2
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the primary outcomes (changes in toe arterial pressure and wound healing rate) and post diabetic limb salvage rate between a prospective cohort that is 1:1 propensity-scored matched against a retrospective cohort
Time Frame: 12 weeks

The prospective cohort will be 1:1 propensity-scored matched for age, gender and WIfI [wound, ischaemia, foot infection] score on presentation against a retrospective cohort.

Post diabetic limb salvage rate:

  • Tools used: Rate of patients who do not undergo major LEA
  • Unit of measure: 12-week limb salvage rate
12 weeks
Frequency of adverse events
Time Frame: 12 weeks
Adverse events and side effects of the treatment will be registered, so that safety assessments can be done during and after the trial.
12 weeks
Compliance (mean daily treatment time)
Time Frame: 12 weeks
Compliance will be recorded as mean daily treatment time (registered by the device), so that exploratory sub-group analyses on patients with a certain compliance level may be performed.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lo Zhiwen Joseph

Collaborators

Otivio AS

Investigators

  • Principal Investigator: Zhiwen Joseph Lo, Woodlands Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2025

Primary Completion (Estimated)

November 2, 2026

Study Completion (Estimated)

November 2, 2026

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-4641

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be made available on a data repository if required by the publishing journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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