Leg InjuryVISTACARE01NCT02963519
Evaluation of Improved Preparation Time to a Coverage in Patients With Acute Wounds by Use of VistaCare® Versus Dressings
A study testing VistaCare® and Dressings in people with Leg Injury, run by Qualissima at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leg Injury
- What is being tested?
- VistaCare® and Dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesFrance
- Study dates
- Nov 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Patient whose wound does not require surgical debridement after inclusion (if surgical debridement is necessary, it must be performed before inclusion in the study)
Who cannot join
- 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
- Patients with such treatment during or within one month prior to inclusion in the study: corticosteroids, topical corticosteroids at the immunosuppressive wound or radiotherapy
- A patient whose wound is located at a place not compatible with the use of VistaCare®
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- 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 in exclusion period from another clinical trial or participated in a clinical trial in the month before inclusion
- Patient whose wound is more than 2 weeks
- Patient whose wound was treated by hyperbaric chamber
Trial locations and contacts
3 sites in 1 country.
François Dufay contact
France3 sites
Hopital Conception
Marseille
Dominique Casanova
CHU Nantes
Nantes
Franck Duteille
Hôpital Saint Louis
Paris
Maurice Mimoun
About this study
Official title: Evaluation of Improved Preparation Time to a Coverage in Patients With Acute Wounds by Use of the Medical Device VistaCare® Versus Dressings
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
- Conditions
- Leg Injury
- Being tested
- VistaCare®, Dressings
- Medical subject headings
- Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VistaCare®Device
DressingsDevice
| Study group | Role | What they receive |
|---|---|---|
| VistaCare® | Experimental | VistaCare® Medical device for treatment into an editable atmosphere Receives: Device: VistaCare® |
| Dressings | Active comparator | Dressings Adapted to the case Receives: Device: Dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from inclusion day at Day 15 of the quality of the bud
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qualissima
- Sponsor type
- University, hospital or other
- Collaborators
- DTA Medical
- Responsible party
- Sponsor
- Investigators
- Dominique Casanova, Principal investigator, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963519
- Sponsor's protocol ID
- 2016-A00448-43
- Acronym
- VISTACARE01
- Status last verified
- Nov 2016
- First submitted
- 2 Nov 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Improved Preparation Time to a Coverage in Patients With Acute Wounds by Use of the Medical Device VistaCare® Versus Dressings
- ClinicalTrials.gov ID
- NCT02963519
- Acronym / sponsor ID
- VISTACARE01 / 2016-A00448-43
- Conditions
- Leg Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- QualissimaUniversity, hospital or other
- Collaborators
- DTA Medical
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VistaCare® | Experimental | Device: VistaCare®VistaCare® Medical device for treatment into an editable atmosphere |
| Dressings | Active comparator | Device: DressingsDressings Adapted to the case |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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
- Patients with such treatment during or within one month prior to inclusion in the study: corticosteroids, topical corticosteroids at the immunosuppressive wound or radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VistaCare® | Device | VistaCare® |
| Dressings | Device | Dressings |
Primary outcome
Quality of the bud
Time frame: Change from inclusion day at Day 15 of the 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Dufay contact
Dominique Casanova principal investigator
APHM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VistaCare® and Dressings in people with Leg Injury, run by Qualissima at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Dufay (francois.dufay@dtamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of the bud (time frame: Change from inclusion day at Day 15 of the quality of the bud). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.