CClinicalTrials.gg
Sign In
RecruitingNCT06693180Updated Nov 18, 2024

Registry HBOT in DFU

An observational study in Diabetic Foot Ulcers, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Nov 2022; still recruiting 3 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Diabetic Foot Ulcers

Keywords

  • HBOT
  • Diabetic foot ulcer
  • Hyperbaric Oxygen Therapy
  • DFU
  • Peripheral arterial disease
03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's planned enrollment of 600 is above the median of 100 across 186 observational studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

  • Diabetes mellitus
  • Meggitt-Wagner classification grade 2-4, existing > 4 weeks
  • Complete 1 year follow-up

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • HBOT

    Received complementary HBOT

    Other: HBOT

  • Control

    Standard care therapy

Interventions

  • OtherHBOT

    Hyperbaric Oxygen Therapy

06

What researchers measure

Primary outcomes

  1. Major amputation rate

    Major (above the ankle) amputation rate

    Time frame: 1 year

Secondary outcomes

  1. Mortality

    Mortality

    Time frame: 1 year

  2. Amputation-free survival rate

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

    Time frame: 1 year

  3. Complete wound healing

    Complete wound healing

    Time frame: 1 year

  4. Pain score

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

    Time frame: 1 year

  5. Additional vascular interventions

    Additional vascular interventions

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Amsterdam UMC
    Amsterdam, Noord-Holland 1105AZ, Netherlands
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06693180
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Responsible party
Dirk T. Ubbink (Prof., University of Amsterdam) — Principal investigator
First posted
Nov 18, 2024
Start date
Nov 1, 2022
Primary completion
Mar 2025 (estimated)
Completion
Mar 2025 (estimated)
Last update
Nov 18, 2024

Study contacts

Joost R Meijering, MD
Contact
j.r.meijering@amsterdamumc.nl
+310205666019
Dirk T Ubbink, MD, PhD
Contact
d.ubbink@amsterdamumc.nl
+310205666019
Joost R Meijering, MD
study chair · Amsterdam University Medical Center
Dirk T Ubbink, MD, PhD
principal investigator · Amsterdam University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetic Foot→

Other studies from this sponsor

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

Start the discussion