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Registry HBOT in DFU

A

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

Trial contacts and locations

1

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Central trial contact

Dirk T Ubbink, MD, PhD; Joost R Meijering, MD

Data sourced from clinicaltrials.gov

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