Evaluation of Sores Treatment by Oxygenotherapy

Not Applicable

Active, not recruiting

• Conditions: Ulcer Venous
• Interventions: Device: system NATROX (device name)

• Registration Number: NCT03200353
• Lead Sponsor: Fondation Hôpital Saint-Joseph

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-10
• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-27
• Primary Completion: 2019-01-10
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	system NATROX (device name)	Each patient included receive the experimental device system NATROX during 3 to 4 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint Joseph; 🇫🇷 Paris, Ile-de-France, France