Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

ID

NL-OMON52592

ToetsingOnline

Brief title

DIONYSIUS

Condition

Skin and subcutaneous tissue therapeutic procedures
Arteriosclerosis, stenosis, vascular insufficiency and necrosis

Synonym

Ischemic diabetic foot ulcer, wound on the foot with vascular insufficiency

Research involving

Human

Sponsors and support

Primary sponsor :

Academisch Medisch Centrum

Source(s) of monetary or material Support :

Dit project is ingediend voor het doelmatigheidsonderzoek van ZonMw

Intervention

Keyword :

Diabetic foot ulcer, Hyperbaric oxygen therapy, Ischemia, Peripheral Arterial Occlusive Disease

Outcome measures

Major amputation rate (above ankle) and (major)l after 3 years of follow-up

- Amputation-free survival

- Health-related quality of life

- Complete wound healing

- Pain scores

- Need for additional (vascular) interventions

- Cost-effectiveness and budget impact

- Mortality

- Patients perception of improvement

- TcpO2 before, during and after HBOT

Background summary

Diabetic foot ulcers, often associated with ischemia, are a major healthcare
problem leading to major amputations. Evidence shows that HBOT appears to
prevent major amputations in these patients with ischemic diabetic foot ulcers.

Study objective

This study has been transitioned to CTIS with ID 2024-511743-26-00 check the CTIS register for the current data.

Primary Objective:
Major amputation rate after 12-months of follow-up

Secondary Objectives:
- Amputation-free survival
- Health-related quality of life
- Complete wound healing
- Pain scores
- Need for additional (vascular) interventions
- Cost-effectiveness and budget impact
- Mortality
- Patients perception of improvement
- TcpO2 before, during and after HBOT

Study design

Multinational randomized clinical trial with an adaptive (multi-arm,
multi-stage; MAMS) design, with a follow-up of 3 years. Patients will be
randomized to receive standard treatment with 0, 20, 30 or a minimum of 40 HBOT
treatments.

Patients receive 20, 30 or 40 sessions of HBOT. The sessions last between the
90 and 120 minutes at 2.2-2.5 ATA.

Study burden and risks

All patients will receive standard wound care and (if possible) endovascular or
surgical revascularization, irrespective of their allocation. HBOT is a
generally accepted and reimbursed indication for the treatment of DFUs. The
risks of HBOT are regarded as low. Patients in the HBOT groups will undergo 20,
30 or 40 HBOT sessions. Patients will be asked to fill in questionnaires at
four time points, and to score their pain weekly during the first 8 weeks.
Three visits to their outpatient surgical clinic will be scheduled, which do
not deviate from usual care.

Public

Academisch Medisch Centrum

Meibergdreef 9
Amsterdam 1105AZ
NL

Scientific

Academisch Medisch Centrum

Meibergdreef 9
Amsterdam 1105AZ
NL

Listed location countries

Netherlands

Adults (18-64 years)

Elderly (65 years and older)

Inclusion criteria

1. Type I or II diabetes
2. Meggitt-Wagner 3 or 4 lower extremity ulcer(s), present for at least 4 weeks
or after a minor amputation because of a previously existing ischemic DFU. In
case more than one ulcer is present, the largest will be observed as target
ulcer
3. Leg ischemia, 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. Adults
6. 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

Design

Study phase :

4

Study type :

Interventional

Intervention model :

Parallel

Allocation :

Randomized controlled trial

Masking :

Open (masking not used)

Primary purpose :

Treatment

Recruitment

NL

Recruitment status :

Completed

Start date (anticipated) :

08-10-2021

Enrollment :

150

Type :

Actual

Medical products/devices used

Product type :

Medicine

Brand name :

(Hyperbaric) Oxygen

Generic name :

(Hyperbaric) Oxygen

Registration :

Yes - NL outside intended use

Approved WMO

Date :

13-08-2020

Application type :

First submission

Review commission :

METC Amsterdam UMC

Approved WMO

Date :

11-12-2020

Application type :

First submission

Review commission :

METC Amsterdam UMC

Approved WMO

Date :

13-05-2022

Application type :

Amendment

Review commission :

METC Amsterdam UMC

Approved WMO

Date :

24-01-2023

Application type :

Amendment

Review commission :

MEC Academisch Medisch Centrum (Amsterdam)

Kamer G4-214

Postbus 22660

1100 DD Amsterdam

020 566 7389

mecamc@amsterdamumc.nl

Followed up by the following (possibly more current) registration