Registry HBOT in DFU | NCT06693180

Studies
Registry HBOT in DFU

NCT06693180

Sponsor

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

Status

Recruiting

Last Update Posted

Nov 18, 2024Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Diabetic Foot Ulcers

Interventions

HBOT

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2022Actual

Primary Completion Date

Mar 2025Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Nov 7, 2024

First Submission Date that Met QC Criteria

Nov 15, 2024

First Posted Date

Nov 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2024

Last Update Posted Date

Nov 18, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dirk T. Ubbink, Prof., University of AmsterdamPrincipal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HBOT		Received complementary HBOT	Other: HBOT
Control		Standard care therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HBOT	Other	Hyperbaric Oxygen Therapy	HBOT

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Mortality	Mortality	1 year
Amputation-free survival rate	Amputation-free survival rate: percentage of patients who are alive with their leg.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joost R Meijering, MD	Contact	+310205666019		j.r.meijering@amsterdamumc.nl
Dirk T Ubbink, MD, PhD	Contact	+310205666019		d.ubbink@amsterdamumc.nl

Overall Officials

Name	Affiliation	Role
Joost R Meijering, MD	Amsterdam University Medical Center	Study Chair
Dirk T Ubbink, MD, PhD	Amsterdam University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amsterdam UMC	Recruiting	Amsterdam	North Holland	1105AZ	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided