Registry HBOT in DFU
Recruiting
- Conditions
- Diabetic Foot Ulcers
- Registration Number
- NCT06693180
- Brief Summary
Overview of available data to assess the benefits of HBOT to DFU patients
- Detailed Description
10 year retrospective registry to measure outcomes regarding major amputations, mortality, hospital admissions in patients with a diabetic foot ulcer with peripheral ischaemia. Two groups will be compared: complementary HBOT and a control group.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major amputation rate 1 year Major (above the ankle) amputation rate
- Secondary Outcome Measures
Name Time Method Mortality 1 year Mortality
Amputation-free survival rate 1 year Amputation-free survival rate: percentage of patients who are alive with their leg.
Complete wound healing 1 year Complete wound healing
Pain score 1 year Pain score (10-point Visual Analogue Scale; 0= no pain, 10 is intolerable pain)
Additional vascular interventions 1 year Additional vascular interventions
Trial Locations
- Locations (1)
Amsterdam UMC
🇳🇱Amsterdam, Noord-Holland, Netherlands