Registry HBOT in DFU

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Enrolling

Conditions: Diabetic Foot Ulcers

Treatments: Other: HBOT

Study type: Observational

Funder types: Other

Identifiers

NCT06693180

2024.0066

Details and patient eligibility

About

Overview of available data to assess the benefits of HBOT to DFU patients

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

HBOT

Description:

Received complementary HBOT

Treatment:

Other: HBOT

Control

Description:

Standard care therapy