Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-29

Study Completion Date

2023-10-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Prospective, open-label, multi-centre study evaluating the performance of the VistaCare® wound healing device in routine practice.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wound Heal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vista care

Prospective, open-label, multi-centre study evaluating the performance of the VistaCare® wound healing device in routine practice.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* -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

Exclusion Criteria

* -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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

BLAISE

Grenoble, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

sophie blaise, MD PhD

Role: CONTACT

Phone: 33476765547

Email: [email protected]

fatima bouchafa, CRA

Role: CONTACT

Phone: 33476765547

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

sophie blaise, MDPhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

38RC21.0312

Identifier Type: -

Identifier Source: org_study_id