Clinical trial NCT03790202: VistaCare® in the Treatment of Wounds of the Lower Extremity
Official title: Open Label Assessment of VistaCare® Treatment in Current Medical Practice in Patients With Acute and Chronic Leg Wounds.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Heal
Keywords: wound
VistaCare
wound healing
controlled atmosphere
Lead sponsor: DTAMedical SAS
Sponsor class: INDUSTRY
First posted: 2018-12-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients addressed to the hospital investigators, aged 18 and more, suffering from acute or chronic lower extremity wounds

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the global Safety of use of the VistaCare® medical device in standard medical practice
timeFrame: up to 30 days
measure: Assessment of the global Performance of the VistaCare® device in standard medical practice
timeFrame: up to 30 days
Secondary outcomes:
measure: Assessment of time under VistaCare treatment till secondary treatment decision
timeFrame: up to 15 days
measure: Wound surface calorimetric assessment of wound status
timeFrame: 30 days
measure: Safety assessment of the VistaCare® treatment through monitoring of the frequency of adverse events
timeFrame: throughout 30 days
measure: TcPO2 assessment
timeFrame: up to 30 days
measure: Quality of Life assessments
timeFrame: throughout 30 days
measure: Duration of hospitalization
timeFrame: throughout 30 days
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHU Henri Mondor
city: Marseille
country: France
facility: Hôpital La Timone
city: Marseille
country: France
facility: Hôpital de la Conception
city: Marseille
country: France
facility: Hôpital La Timone
city: Nantes
country: France
facility: CHU de Nantes Centre des Brûlés
Study officials:
affiliation: Hôpital de la Conception, Marseille, France
name: Dominique Casanova, MD Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital de la Timone, Marseille, France
name: Regis Legré, MD Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital de la Timone, Marseille, France
name: Pierre-Edouard Magnan, MD Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Henri Mondor, Créteil, France
name: Pascal Desgranges, MD Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Nantes, France
name: Franck Duteille, MD Pr
role: PRINCIPAL_INVESTIGATOR
References: