NCT02545374

Brief Summary

Estimate in 6 months the impact of the telemedicine on the cure rate of the chronic wounds compared with the usual care(with or without CICAT-LR Network).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

1.4 years

First QC Date

September 2, 2015

Last Update Submit

April 11, 2016

Conditions

Resident of Languedoc-roussillonCarrying a Chronic Wound

Keywords

chronic woundtablettelemedicinewounds consultationSmartphone

Outcome Measures

Primary Outcomes (2)

  • Rate of healed chronic wounds during a telemedicine care

    Rate of healed chronic wounds during a telemedicine care versus during a usual medical care

    Six months after inclusion

  • Rate of healed chronic wounds during a usual medical care

    Rate of healed chronic wounds during a telemedicine care versus during a usual medical care

    Six months after inclusion

Secondary Outcomes (7)

  • Result to the questionnaire on the quality of life: EQ-5D

    Six months after inclusion

  • A measure of the costs of the management of the disease

    Seven months after the inclusion of the last patient

  • A measure of the costs of the intervention assessed

    Seven months after the inclusion of the last patient

  • The total healing time

    Six months after inclusion

  • The decrease in centimeters of the wound surface to 6 months

    Six months after inclusion

  • +2 more secondary outcomes

Study Arms (2)

Telemedicine

EXPERIMENTAL

In the telemedicine arm, all patients will be supported by Telemedicine protocol according to the development of telemedicine in the region. The use of teleconsultation allows the couple expert doctor / nurse expert to perform a complex of wound assessment consultation and / or chronic. The use of telemedicine allows for acts of telecare, when the nurse applicant sought a remote support of an expert nurse (under the responsibility of a doctor) for the realization of an act. The use of tele-expertise enables physicians to remotely bring special expertise to improve patient care.

Other: Telemedicine

Control

ACTIVE COMPARATOR

In the control arm, patient care depend on his home, as is currently the case: * If it is in the action zone of Cicat-LR network, then it will be supported by an expert nurse of the network that are physically visit the patient's home-lon is the protocols established by the network. * If not, then it will be supported by the customs of the attending physician and nursing teams who follow him.

Other: Control

Interventions

TelemedicineOTHER
Telemedicine
ControlOTHER
Control

Eligibility Criteria

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

You may qualify if:

  • Being adult
  • Taken up residence on the Languedoc-Roussillon
  • Patient carrying a wound with healing or improvement objective (wound closure or the appearance of 40% of granulation)
  • Informed consent signed,
  • Patient member of the Security Social
  • Patient having a visiting nurse.

You may not qualify if:

  • Patient in vital or functional emergency situation during the first call or during the consultation
  • Tumoral wound
  • dialysis patient
  • Arteritis of stage 4 and not revascularizable
  • Absence of regular doctor and visiting nurse
  • patient refusal
  • Refusal of one of the health professionals participating in the pathology care
  • Anybody incapable to communicate and to answer the questions
  • Pregnant or nursing woman
  • Subject deprived of freedom by court or administrative order
  • Major subject protected by the law
  • For the patients in telemedicine: refusal of the collaboration agreement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wound healing Department

Montpellier, 34295, France

Location

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2015

First Posted

September 10, 2015

Study Start

May 1, 2014

Primary Completion

October 1, 2015

Study Completion

March 1, 2016

Last Updated

April 12, 2016

Record last verified: 2016-04

Locations

FR(1)