Evaluation of Sores Treatment by Oxygenotherapy

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 Overview

• Status: Active, not recruiting
• Conditions: Ulcer Venous
• Intervention / Treatment: Device: system NATROX (device name)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75014
      • Groupe hospitalier Paris saint Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; Each patient included receive the experimental device system NATROX during 3 to 4 weeks	Device: system NATROX (device name); system NATROX (device name) application on the wounds of lower limbs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Actual): January 10, 2019
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Varicose Ulcer
• Other Study ID Numbers: NATROX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No