Ulcer Venous Clinical Trial
Official title:
Evaluation of Sores Treatment by Oxygenotherapy
Verified date | April 2023 |
Source | Groupe Hospitalier Paris Saint Joseph |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 31 |
Est. completion date | December 31, 2023 |
Est. primary completion date | January 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - infected ulcers - necrosed ulcers - Arterial ulcers requiring a revascularisation. - Ulcers whose surface is superior in 10x10 cm. |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier Paris Saint Joseph | Paris | Ile-de-France |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Paris Saint Joseph |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of patients received the entire treatment (3 to 4 weeks of oxygenotherapy) in home medical care | Patients who have received the entire treatment. | 4 weeks | |
Secondary | 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 | 1-2 month | |
Secondary | percentage of patient who stopper the treatment | number of patients who have to stop the treatment because of non tolerability among all included patient | 4 weeks |
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