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

Wound Heal Clinical Trial

— VISTA CARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05133570
• Other study ID #: 38RC21.0312
• Status: Recruiting
• Start date: October 29, 2021
• Est. completion date: October 29, 2023

Study information

• Verified date: October 2021
• Source: University Hospital, Grenoble
• Contact: sophie blaise, MD PhD
• Phone: 33476765547
• Email: SBlaise[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 29, 2023
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Heal

Intervention

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

Locations

Country	Name	City	State
France	BLAISE	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the healing performance of the VistaCare® device in routine practice in patients with chronic arterial leg wounds.		2 years