Registry HBOT in DFU
Registry Hyperbaric Oxygen in Diabetic Foot Ulcer
1 other identifier
observational
600
1 country
1
Brief Summary
Overview of available data to assess the benefits of HBOT to DFU patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 7, 2024
CompletedFirst Posted
Study publicly available on registry
November 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedNovember 18, 2024
November 1, 2024
2.3 years
November 7, 2024
November 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major amputation rate
Major (above the ankle) amputation rate
1 year
Secondary Outcomes (5)
Mortality
1 year
Amputation-free survival rate
1 year
Complete wound healing
1 year
Pain score
1 year
Additional vascular interventions
1 year
Study Arms (2)
HBOT
Received complementary HBOT
Control
Standard care therapy
Interventions
Eligibility Criteria
Adult patients suffering from diabetes and peripheral ischaemia who have a diabetic foot ulcer for longer than 4 weeks.
You may qualify if:
- Diabetes mellitus
- Meggitt-Wagner classification grade 2-4, existing \> 4 weeks
- Complete 1 year follow-up
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Amsterdam UMC
Amsterdam, North Holland, 1105AZ, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Joost R Meijering, MD
Amsterdam University Medical Center
- PRINCIPAL INVESTIGATOR
Dirk T Ubbink, MD, PhD
Amsterdam University Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
November 7, 2024
First Posted
November 18, 2024
Study Start
November 1, 2022
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
November 18, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share