Wound HealVISTA CARENCT05133570
Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities
An observational study of Wound Heal, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The prevalence of chronic wounds is around 2 million people in France per year. A chronic wound is a wound that has been evolving for more than 6 weeks. The main causes are: venous causes, arterial causes and microcirculatory causes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- vista care
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 29 Oct 2021to 29 Oct 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient whose wound to be studied is located in a location compatible with the use of VistaCare®, namely the leg including the knee but excluding the upper thigh with arterial disease
Who may be able to join
- -Patient able and willing to comply with the requirements of the including hospitalization for up to 15 days.
- Patient whose wound to be studied is located in a location compatible with the use of VistaCare®, namely the leg including the knee but excluding the upper thigh
- Agreement of the study no-objection form
- Age greater than or equal to 18 years
- Patient affiliated to a social security scheme
Who cannot join
- -Patient with general signs of infection at the time of inclusion (fever, lymphangitis, pus ...). Patient with active smoking Subject under guardianship or deprived of liberty Failure to obtain patient consent
Trial locations and contacts
1 site in 1 country.
fatima bouchafa, CRA contact
France1 site, 1 recruiting
- Recruiting
BLAISE
Grenoble, 38400
sophie blaise, MDPhD
About this study
The prevalence of chronic wounds is around 2 million people in France per year. A chronic wound is a wound that has been evolving for more than 6 weeks. The main causes are: venous causes, arterial causes and microcirculatory causes. In some aetiologies (particularly arterial causes), there is no radical therapeutic solution (no possibility of revascularisation) and the wounds are often difficult to treat and may even eventually lead to amputation. The recommendations for treating wounds are (in addition to carrying out an etiological treatment when possible) to carry out mechanical detersion and to maintain a moist wound environment. In addition to various medical devices such as dressings, adjuvant treatments that are not specific to the etiology of the wound, such as electrotherapy, negative pressure therapy or other devices such as the VistaCare®, are indicated in France.
Read the detailed description
Prospective, open-label, multi-centre study evaluating the performance of the VistaCare® wound healing device in routine practice.
- Conditions
- Wound Heal
- Being tested
- vista care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vista careDevice
Prospective, open-label, multi-centre study evaluating the performance of the VistaCare® wound healing device in routine practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the healing performance of the VistaCare® device in routine practice in patients with chronic arterial leg wounds.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start29 Oct 2021
- Primary completion29 Oct 2021
- Study completion29 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133570
- Sponsor's protocol ID
- 38RC21.0312
- Acronym
- VISTA CARE
- Status last verified
- Oct 2021
- First submitted
- 12 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities
- ClinicalTrials.gov ID
- NCT05133570
- Acronym / sponsor ID
- VISTA CARE / 38RC21.0312
- Conditions
- Wound Heal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2023 (estimated)
- First posted
- 24 Nov 2021 (actual)
- 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.
The prevalence of chronic wounds is around 2 million people in France per year. A chronic wound is a wound that has been evolving for more than 6 weeks. The main causes are: venous causes, arterial causes and microcirculatory causes. In some aetiologies (particularly arterial causes), there is no radical therapeutic solution (no possibility of revascularisation) and the wounds are often difficult to treat and may even eventually lead to amputation. The recommendations for treating wounds are (in addition to carrying out an etiological treatment when possible) to carry out mechanical detersion and to maintain a moist wound environment. In addition to various medical devices such as dressings, adjuvant treatments that are not specific to the etiology of the wound, such as electrotherapy, negative pressure therapy or other devices such as the VistaCare®, are indicated in France.
Detailed description
Prospective, open-label, multi-centre study evaluating the performance of the VistaCare® wound healing device in routine practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient whose wound to be studied is located in a location compatible with the use of VistaCare®, namely the leg including the knee but excluding the upper thigh with arterial disease
Key inclusion criteria (5 listed)
- -Patient able and willing to comply with the requirements of the including hospitalization for up to 15 days.
- Patient whose wound to be studied is located in a location compatible with the use of VistaCare®, namely the leg including the knee but excluding the upper thigh
- Agreement of the study no-objection form
- Age greater than or equal to 18 years
- Patient affiliated to a social security scheme
Key exclusion criteria (1 listed)
- -Patient with general signs of infection at the time of inclusion (fever, lymphangitis, pus ...). Patient with active smoking Subject under guardianship or deprived of liberty Failure to obtain patient consent
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 |
|---|---|---|
| vista careProspective, open-label, multi-centre study evaluating the performance of the VistaCare® wound healing device in routine practice. | Device | – |
Primary outcome
Evaluation of the healing performance of the VistaCare® device in routine practice in patients with chronic arterial leg wounds.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
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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.
fatima bouchafa, CRA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Heal, run by University Hospital, Grenoble at 1 site 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 5 inclusion and 1 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 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 sophie blaise, MD PhD (33476765547, SBlaise@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the healing performance of the VistaCare® device in routine practice in patients with chronic arterial leg wounds. (time frame: 2 years). 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 24 Nov 2021.