Overview
Sponsor-declared trial summary
Fracture-Related Infection
The main objective of the SOLDIER pilot trial is to determine whether a subsequent randomized controlled trial on the potential added value of supplementary hyperbaric oxygen therapy in the treatment of fracture-related infection as performed using the current study design is feasible.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2026-06-22
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2026-525871-24-00
- ClinicalTrials.gov
- NCT07535164
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The main objective of the SOLDIER pilot trial is to determine whether a subsequent randomized controlled trial on the potential added value of supplementary hyperbaric oxygen therapy in the treatment of fracture-related infection as performed using the current study design is feasible.
Conditions and MedDRA coding
Fracture-Related Infection
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Age ≥ 18 years
- Confirmed or highly suspected post-traumatic FRI of the lower limb, for which surgical intervention will be conducted
Exclusion criteria 4
- Patients with a known contraindication for HBOT: untreated pneumothorax; epilepsy; middle ear or thorax surgery in the previous 12 months; inability to equalize the ears; COPD grade 4 or other severe air trapping lung disease; presence of a device that is not known to be compatible with HBOT; severe claustrophobia; pregnancy; BMI ≥ 35; obstructive sleep apnoea syndrome or obesity hypoventilation syndrome with a chronic increased PaCO2 > 6.4 kPa
- Patients with an early (i.e. diagnosed < 6 weeks post initial trauma) FRI, which is treated by DAIR-procedure (Debridement, Antibiotics, Implant Retention) without soft tissue reconstruction
- Patients with an active isolation precautions protocol which is incompatible with treatment in a hyperbaric chamber (i.e. with multiple patients in the chamber at the same time)
- Inability to understand Dutch or English
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Number of subjects included after one year study duration
- Number of HBOT sessions completed by each subject in the intervention group
- Completeness of acquired data on patient-reported outcome measures
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB14733MIG · Substance
- Active substance
- Oxygen
- Pharmaceutical form
- MEDICINAL GAS, COMPRESSED
- Route of administration
- INHALATION
- Max daily dose
- 100 % (V/V) percent volume/volume
- Max total dose
- 100 % (V/V) percent volume/volume
- Max treatment duration
- 30 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Coordinating investigator
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Coordinating investigator
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2026-525871-24-00_redacted | 2 |
| Protocol (for publication) | D4_Patient facing documents_EQ-5D | 1 |
| Protocol (for publication) | D4_Patient facing documents_LIMB-Q | 1 |
| Protocol (for publication) | D4_Patient facing documents_Return to life role | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_2026-525871-24-00 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults_2026-525871-24-00 | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patienteninformatie Hyperbare geneeskunde | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC_Zuurstof Medicinaal Gasvormig SOL 100 vv medicinaal gas samengeperst | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_Dutch_2026-525871-24-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-02 | Netherlands | Acceptable 2026-06-22
|
2026-06-22 |