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NCT Number: NCT06693180

Registry HBOT in DFU

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

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Key information

Conditions

Diabetic Foot Ulcers Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Peripheral Arterial Disease Peripheral Vascular Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location status: Recruiting

Location contact

Joost R Meijering, MD

CONTACT

[email protected]

+310205666019

Joost R Meijering, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HBOT

Other

Hyperbaric Oxygen Therapy

Primary outcomes

  1. Major amputation rate

    Time frame: 1 year

    Major (above the ankle) amputation rate

Secondary outcomes

  1. Mortality

    Time frame: 1 year

    Mortality

  2. Amputation-free survival rate

    Time frame: 1 year

    Amputation-free survival rate: percentage of patients who are alive with their leg.

  3. Complete wound healing

    Time frame: 1 year

    Complete wound healing

  4. Pain score

    Time frame: 1 year

    Pain score (10-point Visual Analogue Scale; 0= no pain, 10 is intolerable pain)

  5. Additional vascular interventions

    Time frame: 1 year

    Additional vascular interventions

Study contacts

Contact information is provided by the study sponsor or research team.

Dirk T Ubbink, MD, PhD

CONTACT

[email protected]

+310205666019

Joost R Meijering, MD

CONTACT

[email protected]

+310205666019

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Registry Hyperbaric Oxygen in Diabetic Foot Ulcer

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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