To investigate the therapeutic efficacy and feasibility of hyperbaric oxygen (HBO) in addition to standard wound care in patients with pyoderma gangrenosum wounds.
ID
Source
Brief title
Condition
- Immune disorders NEC
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the clinical effectiveness in wound healing time (full
re-epithelialization) and to confirm the hypothesis the feasibility and
possible efficacy of hyperbaric oxygen therapy in patients with pyoderma
gangrenosum refractory to standard prednisone therapy.
Secondary outcome
- Changes in markers of inflammation, mRNA expression in micro-biopsies in
wound edges.
- Alterations in mitochondrial O2 levels
- The number of activated neutrophils in peripheral venous blood.
- To assess the effect of HBOT on Pain reduction (NRS score).
- To assess the effect of HBOT on Health Related-Quality of Life (WOUND-Q).
- To assess the prevalence of recurrence of PG in patients treated with and
without adjuvant HBOT.
Background summary
Pyoderma gangrenosum (PG) is a rare, uncommon auto-inflammatory neutrophilic
dermatosis characterized by a spectrum of clinical presentations with variable
courses. Diagnosis and management are challenging in PG, and treatment is
directed towards reducing the associated inflammation that leads to ulceration
including systemic prednisone and anti-TNF alpha therapy. Positive effects of
hyperbaric oxygen (HBO) therapy have been proposed in small case series.
Study objective
To investigate the therapeutic efficacy and feasibility of hyperbaric oxygen
(HBO) in addition to standard wound care in patients with pyoderma gangrenosum
wounds.
Study design
Prospective cohort study with long-term (one year) follow-up.
Intervention
30 sessions of HBO therapy at 2.4-2.5 atmosphere absolute in addition to
treatment conform clinical practice. Controls will be treated according to
clinical practice.
Study burden and risks
Burden: All 15 patients need to undergo 30 sessions of hyperbaric oxygen
treatment (6 weeks, 5 times a week, 110 minutes per session) at 2.4 to 2.5
atmosphere absolute.The risks of HBOT are regarded as low. Extensive medical
intakes by a hyperbaric physician will exclude substantial risks for patients
during hyperbaric exposure.
Other study procedures such as non-invasive wound measurement is a part of
standard clinical practice in pyoderma patients, only specific wound related
laboratory measurements (non-invasive mitochondria measurement, micro-invasive
biopsy of wound edges and neutrophil counts in venous blood) are extra for this
study and have a low risk of complications. There is no additional burden
involving the patient reported outcomes (questionnaires: pain score and
WOUND-Q).
Benefits: patients could potentially benefit from this treatment in terms of
faster wound healing time, improved health and quality of life and pain
reduction.
Dr.Molewaterplein 40
Rotterdam 3015 CA
NL
Dr.Molewaterplein 40
Rotterdam 3015 CA
NL
Listed location countries
Age
Inclusion criteria
• - 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 criteria
• Language barrier
• Unable to give informed consent
- Pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-006013-11-NL |
| CCMO | NL80793.078.22 |