Ulcer Venous
Conditions
Brief 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. 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.
Interventions
DEVICEsystem NATROX (device name)
system NATROX (device name) application on the wounds of lower limbs
Sponsors
Fondation Hôpital Saint-Joseph
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients received the entire treatment (3 to 4 weeks of oxygenotherapy) in home medical care | 4 weeks | Patients who have received the entire treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of patients who can receive skin graft after the therapy | 1-2 month | patient eligible to skin graft after the therapy indicate the success of the NATROX system |
| percentage of patient who stopper the treatment | 4 weeks | number of patients who have to stop the treatment because of non tolerability among all included patient |
Countries
France
Outcome results
None listed