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

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Heal
• Intervention / Treatment: Device: vista care

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 12

Contacts and Locations

• Study Contact: Name: sophie blaise, MD PhD; Phone Number: 33476765547; Email: SBlaise@chu-grenoble.fr
• Study Contact Backup: Name: fatima bouchafa, CRA; Phone Number: 33476765547

Study Locations

• France
  • Grenoble, France, 38400
    • Recruiting
    • BLAISE
    • Contact: sophie blaise, MDPhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the healing performance of the VistaCare® device in routine practice in patients with chronic arterial leg wounds.	2 years

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2021
• Primary Completion (Actual): October 29, 2021
• Study Completion (Anticipated): October 29, 2023

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 38RC21.0312

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No