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.
Planned or seeking to enroll investigators, or needing assistance
Call for collaborators in an international RCT on HBOT for ischemic diabetic foot ulcers.
The treatment of (ischemic) diabetic foot ulcers is an approved indication for HBOT, as acknowledged by the EUBS/SPUMS. 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 is planning to initiate an international randomized clinical trial, as a follow-up of the DAMO2CLES trial (Santema KTB, et al. Diabetes Care 2018).
This trial 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 would like to repeat this trial on a larger, international scale. To explore the feasibility of such an endeavor, we are inviting hyperbaric clinics to show their interest in participating in this trial.
Provisional study characteristics:
- Inclusion criteria: Patients with diabetes type I or II, a foot ulcer, ischemia of the index limb and at least a one-year life expectancy.
- HBOT protocol: at least 30 sessions (90 minutes) at 2.4 ATA
- Follow-up: one year
- Primary outcome measures: Mortality, amputation rate (major and minor), amputation-free survival, complete ulcer healing.
We are open for any constructive suggestions for improvement.
If you would like additional information, have suggestions, or would like to participate in this trial, please contact:
Robin Brouwer, MD, study coordinator (firstname.lastname@example.org), Dr. Rigo Hoencamp, Prof. dr. Rob van Hulst and Prof. dr. Dirk Ubbink, project supervisors.