Registry HBOT in DFU

November 15, 2024 updated by: Dirk T. Ubbink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Registry Hyperbaric Oxygen in Diabetic Foot Ulcer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Recruiting
        • Amsterdam UMC
        • Contact:
        • Contact:
          • Joost R Meijering, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients suffering from diabetes and peripheral ischaemia who have a diabetic foot ulcer for longer than 4 weeks.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HBOT
Received complementary HBOT
Other: HBOT
Hyperbaric Oxygen Therapy
Control
Standard care therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major amputation rate
Time Frame: 1 year
Major (above the ankle) amputation rate
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 1 year
Mortality
1 year
Amputation-free survival rate
Time Frame: 1 year
Amputation-free survival rate: percentage of patients who are alive with their leg.
1 year
Complete wound healing
Time Frame: 1 year
Complete wound healing
1 year
Pain score
Time Frame: 1 year
Pain score (10-point Visual Analogue Scale; 0= no pain, 10 is intolerable pain)
1 year
Additional vascular interventions
Time Frame: 1 year
Additional vascular interventions
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Chair: Joost R Meijering, MD, Amsterdam University Medical Center
  • Principal Investigator: Dirk T Ubbink, MD, PhD, Amsterdam University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Estimated)

November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024.0066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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