Diabetic Foot UlcersNCT06693180
Registry HBOT in DFU
An observational study of Diabetic Foot Ulcers, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Overview of available data to assess the benefits of HBOT to DFU patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- HBOT
- How many people
- 600 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2022to Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients suffering from diabetes and peripheral ischaemia who have a diabetic foot ulcer for longer than 4 weeks.
Who may be able to join
- Diabetes mellitus
- Meggitt-Wagner classification grade 2-4, existing > 4 weeks
- Complete 1 year follow-up
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1105AZ
Joost R Meijering, MD, +310205666019, j.r.meijering@amsterdamumc.nl
Joost R Meijering, MD
About this study
Official title: Registry Hyperbaric Oxygen in Diabetic Foot Ulcer
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.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- HBOT
- Keywords
- HBOT, Diabetic foot ulcer, Hyperbaric Oxygen Therapy, DFU, Peripheral arterial disease
- Medical subject headings
- Diabetic Foot, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBOTOther
Hyperbaric Oxygen Therapy
| Study group | Role | What they receive |
|---|---|---|
| HBOT | Received complementary HBOT Receives: Other: HBOT | |
| Control | Standard care therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major amputation rate
Major (above the ankle) amputation rate
Measured: 1 year
Secondary outcomes (5)
Mortality
Mortality
Measured: 1 year
Amputation-free survival rate
Amputation-free survival rate: percentage of patients who are alive with their leg.
Measured: 1 year
Complete wound healing
Complete wound healing
Measured: 1 year
Pain score
Pain score (10-point Visual Analogue Scale; 0= no pain, 10 is intolerable pain)
Measured: 1 year
Additional vascular interventions
Additional vascular interventions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Nov 2022
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk T. Ubbink, University of Amsterdam
- Investigators
- Joost R Meijering, MD, Study chair, Amsterdam University Medical CenterDirk T Ubbink, MD, PhD, Principal investigator, Amsterdam University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693180
- Sponsor's protocol ID
- 2024.0066
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Hyperbaric Oxygen in Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT06693180
- Acronym / sponsor ID
- 2024.0066
- Conditions
- Diabetic Foot Ulcers
- Keywords
- HBOT, Diabetic foot ulcer, Hyperbaric Oxygen Therapy, DFU, Peripheral arterial disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBOT | – | Other: HBOTReceived complementary HBOT |
| Control | – | –Standard care therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients suffering from diabetes and peripheral ischaemia who have a diabetic foot ulcer for longer than 4 weeks.
Key inclusion criteria (3 listed)
- Diabetes mellitus
- Meggitt-Wagner classification grade 2-4, existing > 4 weeks
- Complete 1 year follow-up
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBOTHyperbaric Oxygen Therapy | Other | HBOT |
Primary outcome
Major amputation rate
Time frame: 1 year
Major (above the ankle) amputation rate
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joost R Meijering, MD study chair
Amsterdam University Medical Center
Dirk T Ubbink, MD, PhD principal investigator
Amsterdam University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcers, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joost R Meijering, MD (+310205666019, j.r.meijering@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major amputation rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.