Overview
Sponsor-declared trial summary
Symptomatic Ischemic Ulcer related to Diabetes
The aim of the study is to confirm or refute the hypothesis that HBOT is effective as an adjunctive treatment to standard wound care for patients with an ischemic DFU to prevent major amputations and to establish the optimal number of sessions to obtain this purported effect.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- completed 10 Jun 2025
- Decision date (initial)
- 2024-11-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511743-26-00
- EudraCT number
- 2020-000449-15
- ClinicalTrials.gov
- NCT05804097
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The aim of the study is to confirm or refute the hypothesis that HBOT is effective as an adjunctive treatment to standard wound care for patients with an ischemic DFU to prevent major amputations and to establish the optimal number of sessions to obtain this purported effect.
Conditions and MedDRA coding
Symptomatic Ischemic Ulcer related to Diabetes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Type I or II diabetes
- One or more deep and clinically infected lower extremity ulcers, classified as Meggit-Wagner class 3 or 4, Texas class 2C, 3C, 2D or 3D, or WIfI class W>1, I>1 and fI>0), present for at least 4 weeks or after a minor amputation because of a previously existing ischaemic DFU on a toe or forefoot. In case more than one ulcer is present, the largest will be observed as target ulcer
- Leg ischaemia, characterized by a highest ankle systolic blood pressure < 70 mmHg, or a toe systolic pressure < 50 mmHg or a TcpO2 < 40 mmHg
- Complete assessment of peripheral arterial lesions from the aorta to the pedal arteries with duplex ultrasonography, magnetic resonance angiography, computed tomography angiography and/or intraarterial digital subtraction angiography of the ipsilateral leg
- Patients have to be discussed in, and included after a multidisciplinary consultation.
- Adults
- Written informed consent
Exclusion criteria 10
- Chronic Obstructive Pulmonary Disease (COPD) GOLD IV
- Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within last 3 months, as this interferes with normal wound healing
- End-stage renal disease requiring dialysis
- Metastasized malignancy
- Left ventricular failure with ejection fraction (EF) <20% or external pacemaker
- Recent thoracic surgery or middle ear surgery
- Severe epilepsy
- Uncontrollable high fever
- Pregnancy
- Insufficient proficiency of local language/English, or inability to complete the questionnaires
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Major amputation rate after 12-months of follow-up
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
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
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB14733MIG · Substance
- Active substance
- Oxygen
- Pharmaceutical form
- MEDICINAL GAS, CRYOGENIC
- 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
- 6 Month(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
- Principal Investigator
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Principal Investigator
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 100 | 4 |
| Spain | Ended | 94 | 2 |
| Rest of world
Bahrain
|
— | 350 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol Appendix 2024-511743-26-00 | 1 |
| Protocol (for publication) | D1_Protocol 2024-511743-26-00 for publication | 1.8 |
| Recruitment arrangements (for publication) | Blank document | 1 |
| Recruitment arrangements (for publication) | Blank document | 1 |
| Subject information and informed consent form (for publication) | L1_ICF adults Catalan | 1 |
| Subject information and informed consent form (for publication) | L1_SIS adults Catalan | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS adults Spanish | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults in Dutch | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Zuurstof Medicinaal Gasvormig SOL 100 percent vv medicinaal gas samengeperst | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Zuurstof Medicinaal Vloeibaar SOL 100 percent vv medicinaal gas cryogeen | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-04 | Netherlands | Acceptable 2024-11-18
|
2024-11-18 |