Status:
TERMINATED
Hyperbaric Oxygen Therapy for Pyoderma Gangrenosum
Lead Sponsor:
Erasmus Medical Center
Conditions:
Pyoderma Gangrenosum
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Rationale: Pyoderma gangrenosum (PG) is a rare auto-inflammatory neutrophilic dermatosis characterized by a spectrum of clinical presentations with variable courses. Diagnosis and management are chall...
Detailed Description
INTRODUCTION AND RATIONALE Pyoderma gangrenosum (PG) Background information Pyoderma gangrenosum (PG) is a rare, uncommon auto-inflammatory neutrophilic dermatosis characterized by a spectrum of cli...
Eligibility Criteria
Inclusion
- \- Confirmed consensus on the diagnosis pyoderma gangrenosum by referring specialist, principal and coordinating investigator (dermatologist, clinical immunologist or rheumatologist based on PARACELSUS and Delphi score).
- Unsatisfactory response after six weeks of combined standard wound care and systemic prednisone and/or other anti-inflammatory therapy.
- Fit for hyperbaric oxygen therapy as assessed by the hyperbaric physician.
- Age ≥18 years at baseline
- All genders
- Able and willing to give written informed consent and to comply with the study requirements.
Exclusion
- \- Language barrier
- Unable to give informed consent or to comply with the trial protocol
- Pregnancy
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05343754
Start Date
June 1 2022
End Date
January 14 2024
Last Update
September 19 2024
Active Locations (1)
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1
Erasmus MC
Rotterdam, Netherlands