BridgeMD
New treatment option for Diabetic Foot Ulcer
Official title Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study
ClinicalTrials.gov ID: NCT07291817
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 99
You may be able to join if
- 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)
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.