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Recruiting NCT06693180

Registry HBOT in DFU

— Observational Diabetic Foot Ulcers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HBOT.
Who it may be relevant to
Registry conditions: Diabetic Foot Ulcers. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Registry Hyperbaric Oxygen in Diabetic Foot Ulcer

Overview

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.

Interventions

  • Other HBOT
    Hyperbaric Oxygen Therapy

Primary outcome measures

  • Major amputation rate [Time frame: 1 year]
Secondary outcome measures (5)
  • Mortality [Time frame: 1 year]
  • Amputation-free survival rate [Time frame: 1 year]
  • Complete wound healing [Time frame: 1 year]
  • Pain score [Time frame: 1 year]
  • Additional vascular interventions [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Amsterdam UMC — Amsterdam

Identifiers

NCT: NCT06693180 · 2024.0066

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗