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

NCT05133570 | Unknown

• 1 other identifier: 38RC21.0312
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• Evaluation of the healing performance of the VistaCare® device in routine practice in patients with chronic arterial leg wounds.

  2 years

Interventions

vista care DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

BLAISE

Grenoble, 38400, France

RECRUITING

Central Study Contacts

sophie blaise, MD PhD

CONTACT

33476765547; SBlaise@chu-grenoble.fr

fatima bouchafa, CRA

CONTACT

33476765547

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 24, 2021
• Study Start: October 29, 2021
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2023
• Last Updated: November 24, 2021

Record last verified: 2021-10

Locations

FR (1)