Actively Recruiting
Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study
Led by Lo Zhiwen Joseph · Updated on 2025-12-18
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
L
Lo Zhiwen Joseph
Lead Sponsor
O
Otivio AS
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to comply with all study procedures and available for the study duration
- Male or female aged 21 to 99 years
- Diagnosed with diabetes mellitus
- Toe systolic pressure less than 70 mmHg on the treated leg after revascularization
- Presence of an open chronic foot wound
- Ability and willingness to operate the treatment device and follow the regimen
- Suitable for diabetic limb salvage
You will not qualify if you...
- Known allergic reactions to components of the intermittent negative pressure device
- Participation in another investigational treatment within the last 12 weeks before joining
- Pregnant women or individuals with cognitive impairment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Woodlands Health
Singapore, Singapore
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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