Research page

Over the past few years, it has become evident that research and education in Diving and Hyperbaric Medicine is of paramount importance, not only to increase our scientific knowledge, but also to increase the acceptance of the therapeutic modality “hyperbaric oxygenation” in this era of EBM.
Therefore, on this page, you will find announcements of ongoing (enrolling participating centers) research projects, as well as courses and events.
If you would like to contribute (= advertise your research or course or event), this is free of charge (of course) – just send a mail to the Webmaster with the useful information.

Research projects

Planned or seeking to enroll investigators, or needing assistance

30 August 2021 –  Join the new international DIONYSIUS trial on hyperbaric oxygen for ischaemic diabetic ulcers

The treatment of (ischaemic) diabetic foot ulcers is an approved indication for hyperbaric oxygen therapy (HBOT), as acknowledged by the ECHM. Therefore, in many countries health insurance companies reimburse this treatment. However, substantial skepticism still exists among clinicians due to the limited and conflicting evidence for its effectiveness to promote wound healing and prevent amputations.

To contribute to the evidence-base for HBOT in patients with ischemic diabetic foot ulcers, the clinical research group from the Amsterdam University Medical Centers and Alrijne Hospital have started the DIONYSIUS trial, as a follow-up of the DAMO2CLES trial (Santema KTB, et al. Diabetes Care 2018).

The DAMO2CLES trial, among a few other trials, showed some promising results for HBOT as an adjunctive treatment for these patients in whom vascular surgery may not be feasible anymore. However, the treatment effect was not convincing due to the limited number of patients available for inclusion in a single country.

Therefore, we have initiated this international trial to repeat this trial on a larger, international scale. We currently started the trial in the Netherlands. Spain, Curacao and Bosnia are expected to follow soon and we aim to start in England and Australia later.

We have chosen to use a multi-arm, multi-stage randomized clinical trial. Patients will be allocated to either 0, 20, 30 or at least 40 HBOT-treatments. In the interim-analysis will be decided which groups will continue to the final stage of the study.

Short study summary:

  • Inclusion criteria: Patients with diabetes type I or II, a Wagner grade 3 or 4 foot ulcer, and ischemia of the index limb.
  • HBOT protocol: 20, 30 or at least 40 sessions of 90-120 min HBOT at 2.2-2.5 ATA
  • Follow-up: Up to 3 years
  • Primary outcome measure: Major amputation rate after 12 months
  • Secondary outcome measures:  Minor amputation rate, amputation-free survival, complete ulcer healing, mortality and cost-effectivity.

Since we need up to 544 patients, we still very much welcome new centres to participate. You can find a short version of the study protocol here. If you would like additional information, have suggestions, or would like to participate in this trial, please contact:

Robin Brouwer, MD, study coordinator (r.j.brouwer@amsterdamumc.nl), on behalf of Dr. Rigo Hoencamp, dr. Mark Koelemay, Prof. dr. Rob van Hulst and Prof. dr. Dirk Ubbink, project supervisors.

 

12 May 2020 – Call for interest : COVID-19-HBO Multicenter Trial Invitation

We are inviting hyperbaric centers with experience in and resources available for critically ill patients to a randomized controlled, open label multicenter trial designed to examine the safety and efficacy of hyperbaric oxygen for COVID-19. This trial has been approved by the Swedish Independent Ethics committee (EPM) and approved by Swedish Medicinal Products Agency (MPA) and details are published on clinicaltrials.gov/NCT04327505, Sponsor is Karolinska Institutet, Solna, Sweden Hyperbaric medicine, KI.

The full details of this trial, “A Randomized, Controlled, Open Label, Multicentre Clinical Trial to explore Safety and Efficacy of Hyperbaric Oxygen for preventing ICU admission, Morbidity and Mortality in Adult Patients With COVID-19” will be sent on request. In summary:

Prospective randomized, open label, multi-centre, estimated enrolment: 200 subjects.

  • Study population: adults with moderate COVID-19 admitted to hospital requiring oxygen and at least two risk factors for increased morbidity/mortality.
  • Intervention: Hyperbaric oxygen (HBO) in addition to best practice. HBO: 1.6-2.4 ATA for 30-60 min, maximum 5 treatments within 7 days from inclusion
  • Control: Best practice for COVID-19 pneumonitis
  • Primary endpoint: ICU admission (defined by specific criteria)
  • Main secondary endpoints: 30-day mortality, Time-to-Intubation, Time-to-ICU, Mean change in inflammatory response, Overall Survival
  • Safety and other endpoints in selection: Adverse events, Change in vital parameters (NEWS), Change in oxygen requirement (PFI)

Data will be entered online, using SmartTrial® and randomization will be made online with Randomize.NET. We will support investigators with the paperwork for national regulatory bodies, information and education to set up your department as a site in this trial but expect each site to carry most of their own costs for including subjects. All contributing investigators will be recognized in the subsequent publication of our results. We look forward to your review of this trial and are readily available for communication.

Please contact Coordinating Investigator Anders Kjellberg anders.kjellberg@ki.se, +46760657355 if you are interested in participating, so that we can send you the full protocol and other information.

You can download this invitation and information letter here.