Ulcer VenousNCT03200353
Evaluation of Sores Treatment by Oxygenotherapy
A study testing system NATROX (device name) in people with Ulcer Venous, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Patient with chronic wounds are selected to receive NATROX system ; it's a continous diffusion of oxygen therapy delivery system. This one is put on the wound during a consultation at the hospital and will be followed in home medical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer Venous
- What is being tested?
- system NATROX (device name)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2017to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- accepted to participate
- Patients followed in vascular medicine and entrusted to the home medical care for the bandages of chronic wounds with apathetic ulcers, not presenting of granulation tissue on their surface
Who cannot join
- infected ulcers
- necrosed ulcers
- Arterial ulcers requiring a revascularisation.
- Ulcers whose surface is superior in 10x10 cm.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Patient with chronic wounds are selected to receive NATROX system ; it's a continous diffusion of oxygen therapy delivery system. This one is put on the wound during a consultation at the hospital and will be followed in home medical care. Every 2 days a nurse renew the application at home and patient recharge the system with oxygen every day.
The complete treatment is prescribe for 4 weeks and at the end patient comes to hospital to have a consultation with the doctor.
- Conditions
- Ulcer Venous
- Being tested
- system NATROX (device name)
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
system NATROX (device name)Device
system NATROX (device name) application on the wounds of lower limbs
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Each patient included receive the experimental device system NATROX during 3 to 4 weeks Receives: Device: system NATROX (device name) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients received the entire treatment (3 to 4 weeks of oxygenotherapy) in home medical care
Patients who have received the entire treatment.
Measured: 4 weeks
Secondary outcomes (2)
percentage of patients who can receive skin graft after the therapy
patient eligible to skin graft after the therapy indicate the success of the NATROX system
Measured: 1-2 month
percentage of patient who stopper the treatment
number of patients who have to stop the treatment because of non tolerability among all included patient
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start10 Apr 2017
- Primary completion10 Jan 2019
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcer VenousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle P LAZARETH, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200353
- Sponsor's protocol ID
- NATROX
- Status last verified
- Apr 2023
- First submitted
- 23 Jun 2017
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sores Treatment by Oxygenotherapy
- ClinicalTrials.gov ID
- NCT03200353
- Acronym / sponsor ID
- NATROX
- Conditions
- Ulcer Venous
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient with chronic wounds are selected to receive NATROX system ; it's a continous diffusion of oxygen therapy delivery system. This one is put on the wound during a consultation at the hospital and will be followed in home medical care. Every 2 days a nurse renew the application at home and patient recharge the system with oxygen every day.
The complete treatment is prescribe for 4 weeks and at the end patient comes to hospital to have a consultation with the doctor.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: system NATROX (device name)Each patient included receive the experimental device system NATROX during 3 to 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years
- accepted to participate
- Patients followed in vascular medicine and entrusted to the home medical care for the bandages of chronic wounds with apathetic ulcers, not presenting of granulation tissue on their surface
Key exclusion criteria (4 listed)
- infected ulcers
- necrosed ulcers
- Arterial ulcers requiring a revascularisation.
- Ulcers whose surface is superior in 10x10 cm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| system NATROX (device name)system NATROX (device name) application on the wounds of lower limbs | Device | Active |
Primary outcome
number of patients received the entire treatment (3 to 4 weeks of oxygenotherapy) in home medical care
Time frame: 4 weeks
Patients who have received the entire treatment.
2 secondary outcomes
percentage of patients who can receive skin graft after the therapy
Time frame: 1-2 month
percentage of patient who stopper the treatment
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle P LAZARETH, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing system NATROX (device name) in people with Ulcer Venous, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients received the entire treatment (3 to 4 weeks of oxygenotherapy) in home medical care (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.