Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

NCT ID: NCT05804097

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-08
• Study Completion Date: 2025-05-01

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.

Detailed Description

Objective: The primary objective is to assess the (cost-) effectiveness of HBOT in addition to standard wound care and vascular surgical treatment for patients with a DFU and leg ischaemia.

Study design: An international, multi-arm multi-stage (MAMS) design is chosen to conduct an efficient randomised clinical trial. At a planned interim analysis the best performing study arm(s) will be chosen to continue.

Study population: We need up to 544 patients with a Meggitt-Wagner stage 3 or 4 DFU and proven peripheral ischaemia.

Intervention: Patients will be randomised to receive standard care (wound treatment and surgical interventions following international guidelines) with either 0, 20, 30 or at least 40 sessions of HBOT. These sessions will compromise 90-120 minutes of HBOT at a pressure of 2.2-2.5 ATA according to international standards.

Main study parameters/endpoints: The primary endpoint is major amputation rate after 12 months. Secondary objectives are amputation-free survival, wound healing, health-related quality of life and cost-effectiveness of the interventions.

Conditions

Peripheral Vascular Disease; Diabetic Foot Ulcer; Amputation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

HBOT 20

Patients receiving 20 sessions of concurrent Hyperbaric oxygen treatment

Group Type: EXPERIMENTAL

Hyperbaric oxygen

Intervention Type: DRUG

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

HBOT 30

Patients receiving 30 sessions of concurrent Hyperbaric oxygen treatment

Group Type: EXPERIMENTAL

Hyperbaric oxygen

Intervention Type: DRUG

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

HBOT 40

Patients receiving at least 40 sessions of concurrent Hyperbaric oxygen treatment

Group Type: EXPERIMENTAL

Hyperbaric oxygen

Intervention Type: DRUG

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

Interventions

Hyperbaric oxygen

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Type I or II diabetes

2. 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

3. Leg ischaemia, characterized by a highest ankle systolic blood pressure < 70 mmHg, or a toe systolic pressure < 50 mmHg or a TcpO2 < 40 mmHg

4. 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

5. Patients have to be discussed in, and included after a multidisciplinary consultation.

6. Adults

7. Written informed consent

Exclusion Criteria

1. Chronic Obstructive Pulmonary Disease (COPD) GOLD IV

2. Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within last 3 months, as this interferes with normal wound healing

3. End-stage renal disease requiring dialysis

4. Metastasized malignancy

5. Left ventricular failure with ejection fraction (EF) <20% or external pacemaker

6. Recent thoracic surgery or middle ear surgery

7. Severe epilepsy

8. Uncontrollable high fever

9. Pregnancy

10. Insufficient proficiency of local language/English, or inability to complete the questionnaires

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Dirk T. Ubbink

Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Amsterdam UMC

Amsterdam, Noord-Hollad, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 37230523 (View on PubMed)

Other Identifiers

NL72855.018.20

Identifier Type: -

Identifier Source: org_study_id