VistaCare® in the Treatment of Wounds of the Lower Extremity

DTAMedical

Status: Completed

Conditions: Wound Heal

Treatments: Device: VistaCare®

Study type: Observational

Funder types: Industry

Identifiers

NCT03790202

VistaCare® OPEN PMCF

Details and patient eligibility

About

Assessment of the safety and performance of the VistaCare® medical device in current medical practice in the treatment of acute and chronic lower limb wounds.

Full description

The study is an open-label, prospective, multicenter, post-CE mark (European Conformity assessment indicating marketing approval in Europe) study to assess the safety and performance of the VistaCare® device in the treatment of wounds. The duration of patient follow-up is up to 30 days, with intermediate visits at 3, 7, 15 and 30 days following initiation of treatment with the device.

Up to 30 patients will be recruited in the trial. Assessments will include clinical status, wound status, standardized photography, TcPO2 (trans-cutaneous oxygen pressure assessment) in a study sub-population, visual analogy scales to assess pain and comfort and adverse events monitoring.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female consenting and able patients aged 18 or more affiliated to social security
• presenting with acute or chronic traumatic or surgical lower limb wounds (excluding tumoral excision)
• presenting with no intercurrent pathology which in the opinion of the investigator may interfere with the capacity for wound healing
• patients whose wound is compatible in terms of location with VistaCare treatment
• patient whose wound has a minimal surface of 10 cm2
• patient whose wound does not need surgical Peterson after inclusion (if needed should be performed prior to inclusion)

Exclusion criteria

• Female patients pregnant, lactating, or of childbearing age and not using adequate contraception (pregnancy test mandatory)
• patients incapable of making an informed decision about participation
• patients presenting a condition that interferes with adequate wound healing capacity (uncontrolled diabetes, heavy smokers, auto-immune disease)
• concurrent treatment or treatment within one month prior to inclusion with local or systemic corticosteroids, immunosuppresseurs, chemotherapy or radiotherapy
• wound location incompatible with VistaCare
• general infection signs at the time of inclusion (fever, lymphangitis, pus ...)
• patients presenting with important uncontrolled hemorrhage at the time of inclusion
• patients previously recruited into this trial or any other trial within 1 month, or currently in the exclusion timeframe of another trial
• patients with a wound surface less than 10 cm2
• patient with a would previously treated with hyperbaric chamber
• legally incapacitated, under guardianship or psychiatric patients
• emergency condition prohibiting adequate patient consent prior to inclusion

Trial design

30 participants in 1 patient group

single cohort of up to 30 patients

Description:

patients with acute or chronic lower limb wounds to be treated with the VistaCare® device

Treatment:

Device: VistaCare®