Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study
ConditionDiabetic Foot Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-99
SponsorLo Zhiwen Joseph
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
FlowOx
Device12 weeks treatment with FlowOx for 1 hour twice daily for 12 weeks
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Treatment with FlowOxExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in toe arterial pressure
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
Time frame
12 weeks2
Change in wound surface area
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
Time frame
12 weeksSecondary 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
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
Time frame
12 weeks2
Frequency of adverse events
Adverse events and side effects of the treatment will be registered, so that safety assessments can be done during and after the trial.
Time frame
12 weeks3
Compliance (mean daily treatment time)
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.
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov