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

• Conditions: Wound Heal

• Registration Number: NCT05133570
• Lead Sponsor: University Hospital, Grenoble

Brief 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. 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 Timeline

• Status Verified: 2021-10
• Study Start: 2021-10-29
• Primary Completion: 2021-10-29
• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-23
• Last Update Submitted: 2021-11-23
• Study First Posted: 2021-11-24
• Last Update Posted: 2021-11-24
• Study Completion: 2023-10-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

BLAISE; 🇫🇷 Grenoble, France