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

Sponsor
Lo Zhiwen Joseph
Study ID
NCT07291817
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • FlowOx — DEVICE
    12 weeks treatment with FlowOx for 1 hour twice daily for 12 weeks

Study Details

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.

Key Dates

First listed
Dec 18, 2025
Start date
Nov 3, 2025
Status verified
Jul 2026
Primary completion
Nov 2, 2026
Completion
Nov 2, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Treatment with FlowOx

Primary Outcome Measure

Change in toe arterial pressure [ Time Frame: 12 weeks ]

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