NCT02963519

Brief Summary

Primary objective: Demonstrate that in patients with acute leg wounds with skin defect, VistaCare® accelerates the formation of a quality granulation tissue and reduces preparation time to a cover gesture. Secondary objectives:

  • Evaluate the success of hedging gesture
  • Assess the quality of the bud by colorimetry
  • Assess tolerance
  • Collect medical and economic data on the care of patients included
  • Evaluate the quality of life of patients
  • Assess patient comfort
  • Evaluate the ease of use for the caregiver

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

3 active sites

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

November 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

November 2, 2016

Last Update Submit

November 14, 2016

Conditions

Leg Injury

Outcome Measures

Primary Outcomes (1)

  • Quality of the bud

    Comparison, after the inclusion in the study, between VistaCare® and dressings on preparation time to a cover gesture by daily visual assessment of the quality of the bud.

    Change from inclusion day at Day 15 of the quality of the bud

Study Arms (2)

VistaCare®

EXPERIMENTAL

VistaCare® Medical device for treatment into an editable atmosphere

Device: VistaCare®

Dressings

ACTIVE COMPARATOR

Dressings Adapted to the case

Device: Dressings

Interventions

VistaCare®DEVICE
VistaCare®
DressingsDEVICE
Dressings

Eligibility Criteria

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

You may qualify if:

  • Man or woman
  • Age from 18 to 65 inclusive
  • Patient with acute or leg sores (s), traumatic, with skin defect with or without external fixators and without exposure to fine fabrics (functional tendon, artery, vessel, bone, osteosynthesis material ...). These wounds may be burns, deep second degree only.
  • Patient having no associated pathology
  • Patient has given its written consent, lighting, dated and signed
  • Patient affiliated to a social security scheme
  • Voluntary Patient and able to comply with the protocol requirements
  • Patient whose wound is located below the knee
  • Patient whose wound date of less than 2 weeks
  • A patient whose wound has a minimum area of 10 cm2

You may not qualify if:

  • Pregnant or breastfeeding women
  • Women of childbearing potential not using effective contraception (combined hormonal, IUD) and failing achieving a pregnancy test and getting the result before starting treatment
  • Patients do not speak and do not read French
  • Patient with one or more risk factors such as smoking more than 5 cigarettes a day, diabetes, autoimmune disease
  • A patient whose wound is located at a place not compatible with the use of VistaCare®
  • Patient with traumatic wound leg with exposure to some tissues (functional tendon, artery, vessel, bone, osteosynthesis material ...)
  • Patient with general signs of infection (temperature, lymphangitis, osteitis proven)
  • Patient with a bleeding wound
  • Patient with a burn to a stage other than deep second degree
  • Patients with a wound whose area is less than 10 cm2
  • Patient with a plague of nontraumatic leg
  • Previous participation in this trial
  • Patient whose wound is more than 2 weeks
  • Patient whose wound was treated by hyperbaric chamber

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hopital Conception

Marseille, France

Location

CHU Nantes

Nantes, France

Location

Hôpital Saint Louis

Paris, France

Location

MeSH Terms

Conditions

Leg Injuries

Interventions

Bandages

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Dominique Casanova

    APHM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

François Dufay

CONTACT

francois.dufay@dtamedical.com

Study Design

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

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 15, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2017

Study Completion

January 1, 2018

Last Updated

November 15, 2016

Record last verified: 2016-11

Locations

FR(3)