VistaCare® in the Treatment of Wounds of the Lower Extremity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-18

Study Completion Date

2021-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Wound Heal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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single cohort of up to 30 patients

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

VistaCare®

Intervention Type DEVICE

Controlled atmosphere wound healing device

Interventions

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VistaCare®

Controlled atmosphere wound healing device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No