Registry HBOT in DFU

Last updated: November 15, 2024
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Foot Ulcers

Ulcers

Diabetes And Hypertension

Treatment

HBOT

Clinical Study ID

NCT06693180
2024.0066
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diabetes mellitus

  • Meggitt-Wagner classification grade 2-4, existing > 4 weeks

  • Complete 1 year follow-up

Exclusion

Exclusion Criteria:

  • Chronic Obstructive Pulmonary Disease (COPD) GOLD IV

  • Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroidswithin 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

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: HBOT
Phase:
Study Start date:
November 01, 2022
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • Amsterdam UMC

    Amsterdam, Noord-Holland 1105AZ
    Netherlands

    Active - Recruiting

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