NCT03200353

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

June 23, 2017

Last Update Submit

April 26, 2023

Conditions

Ulcer Venous

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • percentage of patients who can receive skin graft after the therapy

    1-2 month

  • percentage of patient who stopper the treatment

    4 weeks

Study Arms (1)

Active

EXPERIMENTAL

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

Device: system NATROX (device name)

Interventions

system NATROX (device name)DEVICE

system NATROX (device name) application on the wounds of lower limbs

Active

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • infected ulcers
  • necrosed ulcers
  • Arterial ulcers requiring a revascularisation.
  • Ulcers whose surface is superior in 10x10 cm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Isabelle P LAZARETH, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2017

First Posted

June 27, 2017

Study Start

April 10, 2017

Primary Completion

January 10, 2019

Study Completion

December 31, 2023

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)