Evaluation of Sores Treatment by Oxygenotherapy

Fondation Hôpital Saint-Joseph

Status: Active, not recruiting

Conditions: Ulcer Venous

Treatments: Device: system NATROX (device name)

Study type: Interventional

Funder types: Other

Identifiers

NCT03200353

NATROX

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Active

Experimental group

Description:

Each patient included receive the experimental device system NATROX during 3 to 4 weeks

Treatment:

Device: system NATROX (device name)