Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

NCT05804097 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: NL72855.018.20
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this multicenter, multi-national, multi-arm, multi-stage, randomized controlled trial, is to determine the added benefit of hyperbaric oxygen treatment (HBOT) in patients with diabetic foot ulcers and peripheral vascular disease. The main question is: \- What is the difference is the major amputation rate between the study arms? Participants will be randomized to 20, 30 or 40 sessions of HBOT or a control group.

Conditions

Peripheral Vascular Disease; Diabetic Foot Ulcer; Amputation

Keywords

Diabetic Foot Ulcer; Hyperbaric Oxygen; Peripheral Vascular Disease; HBOT; DFU; Major amputation; Diabetes; Ischemia

Outcome Measures

Primary Outcomes (1)

• Major Amputations

  Major amputations, defined as below the knee or above the knee amputations

  12 months after inclusion

Secondary Outcomes (9)

• Amputation-free survival

  Complete follow-up (up to 3 years)

• Health-related quality of life

  Complete follow-up (up to 3 years)

• Complete wound healing

  12 months after inclusion

• Pain scores

  12 months after inclusion

• Need for additional (vascular) interventions

  Complete follow-up (up to 3 years)

Study Arms (4)

Control

NO INTERVENTION

Control group

HBOT 20

EXPERIMENTAL

Patients receiving 20 sessions of concurrent Hyperbaric oxygen treatment

Drug: Hyperbaric oxygen

HBOT 30

EXPERIMENTAL

Patients receiving 30 sessions of concurrent Hyperbaric oxygen treatment

Drug: Hyperbaric oxygen

HBOT 40

EXPERIMENTAL

Patients receiving at least 40 sessions of concurrent Hyperbaric oxygen treatment

Drug: Hyperbaric oxygen

Interventions

Hyperbaric oxygen DRUG

90-120 min sessions of hyperbaric oxygen treatment of 2.2-2.5 ATA

HBOT 20; HBOT 30; HBOT 40

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type I or II diabetes
• One or more deep and clinically infected lower extremity ulcers, classified as Meggitt-Wagner class 3 or 4, Texas class 2C, 3C, 2D or 3D, or WIfI class W\>1, I\>1 and fI\>0), present for at least 4 weeks or after a minor amputation because of a previously existing ischaemic DFU on a toe or forefoot. In case more than one ulcer is present, the largest will be observed as target ulcer
• Leg ischaemia, characterized by a highest ankle systolic blood pressure \< 70 mmHg, or a toe systolic pressure \< 50 mmHg or a TcpO2 \< 40 mmHg
• Complete assessment of peripheral arterial lesions from the aorta to the pedal arteries with duplex ultrasonography, magnetic resonance angiography, computed tomography angiography and/or intraarterial digital subtraction angiography of the ipsilateral leg
• Patients have to be discussed in, and included after a multidisciplinary consultation.
• Adults
• Written informed consent

You may not qualify if:

• Chronic Obstructive Pulmonary Disease (COPD) GOLD IV
• Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within last 3 months, as this interferes with normal wound healing
• End-stage renal disease requiring dialysis
• Metastasized malignancy
• Left ventricular failure with ejection fraction (EF) \<20% or external pacemaker
• Recent thoracic surgery or middle ear surgery
• Severe epilepsy
• Uncontrollable high fever
• Pregnancy
• Insufficient proficiency of local language/English, or inability to complete the questionnaires

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam, Noord-Hollad, 1105 AZ, Netherlands

Location

Related Publications (1)

• Brouwer R, van der Peet R, Hoencamp R, Koelemay M, van Dieren S, van Hulst R, Ubbink D. DIONYSIUS trial: "Does increasing oxygen nurture your symptomatic ischaemic ulcer sufficiently?" Study protocol for an international multicentre randomised trial. BMJ Open. 2023 May 25;13(5):e063503. doi: 10.1136/bmjopen-2022-063503.

  PMID: 37230523 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases; Diabetic Foot; Diabetes Mellitus; Ischemia

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetic Angiopathies; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 7, 2023
• Study Start: October 8, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication and 10 years following article publication.
• Access Criteria: Researchers who provide a scientifically good reason to require access. If approved data can be shared after the signing a Data Access Agreement.

Locations

NL (1)