BridgeMD
DIONYSIUS
EU CTIS ID: 2024-511743-26-00
What this study is testing
The aim of the study is to confirm or refute the hypothesis that HBOT is effective as an adjunctive treatment to standard wound care for patients with an ischemic DFU to prevent major amputations and to establish the optimal number of sessions to obtain this purported effect.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Type I or II diabetes
- One or more deep and clinically infected lower extremity ulcers, classified as Meggit-Wagner class 3 or 4, Texas class 2C, 3C, 2D or 3D, or WIfI class W>1, I>1 and fI>0), present for at least 4 weeks or after a minor amputation because of a previously existing ischaemic DFU on a toe or forefoot. In case more than one ulcer is present, the largest will be observed as target ulcer
- Leg ischaemia, characterized by a highest ankle systolic blood pressure < 70 mmHg, or a toe systolic pressure < 50 mmHg or a TcpO2 < 40 mmHg
- Complete assessment of peripheral arterial lesions from the aorta to the pedal arteries with duplex ultrasonography, magnetic resonance angiography, computed tomography angiography and/or intraarterial digital subtraction angiography of the ipsilateral leg
- Patients have to be discussed in, and included after a multidisciplinary consultation.
- Adults
You likely can't join if
- Chronic Obstructive Pulmonary Disease (COPD) GOLD IV
- Insufficient proficiency of local language/English, or inability to complete the questionnaires
- Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within last 3 months, as this interferes with normal wound healing
- End-stage renal disease requiring dialysis
- Metastasized malignancy
- Left ventricular failure with ejection fraction (EF) <20% or external pacemaker
See the full eligibility criteria
- Type I or II diabetes
- One or more deep and clinically infected lower extremity ulcers, classified as Meggit-Wagner class 3 or 4, Texas class 2C, 3C, 2D or 3D, or WIfI class W>1, I>1 and fI>0), present for at least 4 weeks or after a minor amputation because of a previously existing ischaemic DFU on a toe or forefoot. In case more than one ulcer is present, the largest will be observed as target ulcer
- Leg ischaemia, characterized by a highest ankle systolic blood pressure < 70 mmHg, or a toe systolic pressure < 50 mmHg or a TcpO2 < 40 mmHg
- Complete assessment of peripheral arterial lesions from the aorta to the pedal arteries with duplex ultrasonography, magnetic resonance angiography, computed tomography angiography and/or intraarterial digital subtraction angiography of the ipsilateral leg
- Patients have to be discussed in, and included after a multidisciplinary consultation.
- Adults
- Written informed consent
- Chronic Obstructive Pulmonary Disease (COPD) GOLD IV
- Insufficient proficiency of local language/English, or inability to complete the questionnaires
- Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within last 3 months, as this interferes with normal wound healing
- End-stage renal disease requiring dialysis
- Metastasized malignancy
- Left ventricular failure with ejection fraction (EF) <20% or external pacemaker
- Recent thoracic surgery or middle ear surgery
- Severe epilepsy
- Uncontrollable high fever
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Bahrain
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bahrain. 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 EU CTIS; the study team decides eligibility.