Registry HBOT in DFU
Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Nov 15, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, titled "Registry HBOT in DFU," is studying the effects of Hyperbaric Oxygen Therapy (HBOT) on patients with diabetic foot ulcers (DFU). Diabetic foot ulcers are sores or wounds that can develop in people with diabetes, and they can be hard to heal. The trial aims to gather and analyze data to understand how beneficial HBOT might be for these patients, helping to improve their healing process.
To participate in this study, individuals must have diabetes and a specific type of foot ulcer that has been present for more than four weeks. They should also be willing to complete a one-year follow-up. However, certain conditions may exclude someone from joining, such as having severe lung disease, recent cancer treatment, or other serious health issues. Participants can expect regular check-ups and monitoring during the trial, which will help researchers learn more about the effectiveness of HBOT for improving healing in diabetic foot ulcers.
Gender
ALL
Eligibility 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
About Academisch Medisch Centrum Universiteit Van Amsterdam (Amc Uva)
The Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is a leading academic medical center in the Netherlands, dedicated to advancing healthcare through innovative research, education, and patient care. Affiliated with the University of Amsterdam, AMC-UvA integrates clinical practice with cutting-edge biomedical research, fostering a multidisciplinary approach to medical challenges. The institution actively engages in clinical trials to enhance treatment options and improve patient outcomes, while promoting collaboration among healthcare professionals, researchers, and academic institutions globally. With a commitment to excellence and a focus on translational medicine, AMC-UvA plays a pivotal role in shaping the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Amsterdam, Noord Holland, Netherlands
Patients applied
Trial Officials
Joost R Meijering, MD
Study Chair
Amsterdam University Medical Center
Dirk T Ubbink, MD, PhD
Principal Investigator
Amsterdam University Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported