Back to resultsEvaluation of Sores Treatment by Oxygenotherapy
Primary Purpose
Ulcer Venous
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
system NATROX (device name)
Sponsored by
About this trial
This is an interventional other trial for Ulcer Venous
Eligibility Criteria
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.
Sites / Locations
- Groupe Hospitalier Paris Saint Joseph
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active
Arm Description
Each patient included receive the experimental device system NATROX during 3 to 4 weeks
Outcomes
Primary Outcome Measures
number of patients received the entire treatment (3 to 4 weeks of oxygenotherapy) in home medical care
Patients who have received the entire treatment.
Secondary Outcome Measures
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
percentage of patient who stopper the treatment
number of patients who have to stop the treatment because of non tolerability among all included patient
Full Information
NCT ID
NCT03200353
First Posted
June 23, 2017
Last Updated
April 26, 2023
Sponsor
Fondation Hôpital Saint-Joseph
1. Study Identification
Unique Protocol Identification Number
NCT03200353
Brief Title
Evaluation of Sores Treatment by Oxygenotherapy
Official Title
Evaluation of Sores Treatment by Oxygenotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcer Venous
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Each patient included receive the experimental device system NATROX during 3 to 4 weeks
Intervention Type
Device
Intervention Name(s)
system NATROX (device name)
Intervention Description
system NATROX (device name) application on the wounds of lower limbs
Primary Outcome Measure Information:
Title
number of patients received the entire treatment (3 to 4 weeks of oxygenotherapy) in home medical care
Description
Patients who have received the entire treatment.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
percentage of patients who can receive skin graft after the therapy
Description
patient eligible to skin graft after the therapy indicate the success of the NATROX system
Time Frame
1-2 month
Title
percentage of patient who stopper the treatment
Description
number of patients who have to stop the treatment because of non tolerability among all included patient
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle P LAZARETH, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint Joseph
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Sores Treatment by Oxygenotherapy
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