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NCT Number: NCT07291817

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

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.

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Suitable for diabetic limb salvage

Exclusion criteria

  • Known allergic reactions to components of the INP device.
  • Treatment with another investigational intervention within the last 12 weeks prior to inclusion.
  • Pregnant women or cognitively impaired participants.

Treatment and study plan

FlowOx

Device

12 weeks treatment with FlowOx for 1 hour twice daily for 12 weeks

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Lo Zhiwen Joseph

Other Gov

Collaborators

  • Otivio AS

Registry information

Acronym: INPRESS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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