Evaluating Hyperbaric Oxygen Therapy for Diabetic Foot Ulcers
Official title: Registry Hyperbaric Oxygen in Diabetic Foot Ulcer
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT06693180 · Data updated 2026-11-12
This study looks at whether Hyperbaric Oxygen Therapy can help people with diabetic foot ulcers avoid amputations and hospital stays compared to those who don’t receive the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Amsterdam, North Holland) |
| Status | Recruiting |
| Started | November 1, 2022 |
| Main results expected | March 2025 |
| Study ends | March 2025 |
| Registry record updated | November 18, 2024 |
| Trial ID | NCT06693180 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with diabetes mellitus who have Meggitt-Wagner classification grade 2-4 diabetic foot ulcers that have persisted for more than four weeks.
✕Probably not a fit
Patients with severe comorbidities such as advanced COPD, recent thoracic surgery, or those undergoing chemotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study analyzes a 10-year retrospective registry to assess the outcomes of Hyperbaric Oxygen Therapy (HBOT) in patients suffering from diabetic foot ulcers (DFU) with peripheral ischemia. It compares two groups: those receiving HBOT and a control group not receiving the treatment. The study aims to measure key outcomes such as major amputations, mortality rates, and hospital admissions among participants. By examining this data, the study seeks to provide insights into the effectiveness of HBOT for improving patient outcomes.
Why it matters
Potential benefit: If successful, this study could provide evidence supporting the use of HBOT as an effective treatment for diabetic foot ulcers, potentially reducing the need for amputations.
How similar studies have gone: Previous studies have shown promising results for HBOT in treating diabetic foot ulcers, indicating that this approach has potential based on existing evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diabetes mellitus * Meggitt-Wagner classification grade 2-4, existing \> 4 weeks * Complete 1 year follow-up Exclusion Criteria: * Chronic Obstructive Pulmonary Disease (COPD) GOLD IV * Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within the last 3 months * Metastasized malignancy * Left ventricular ejection fraction (EF) \<20% or external pacemaker * Recent thoracic or middle ear surgery * Severe epilepsy * Uncontrollable high fever * Pregnancy
Where it's running
-
Amsterdam UMC
Amsterdam, North Holland, Netherlands Recruiting
Study contacts
- Principal investigator: Dirk T Ubbink, MD, PhD — Amsterdam University Medical Center
- Study coordinator: Joost R Meijering, MD
- Email: j.r.meijering@amsterdamumc.nl
- Phone: +310205666019
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.