VistaCare® in the Treatment of Wounds of the Lower Extremity

NCT03790202 | Completed

• 1 other identifier: VistaCare® OPEN PMCF
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 5

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.

Conditions

Wound Heal

Keywords

wound; VistaCare; wound healing; controlled atmosphere

Outcome Measures

Primary Outcomes (2)

• Assessment of the global Safety of use of the VistaCare® medical device in standard medical practice

  Assessment of the global safety of VistaCare® in current medical practice in patients with acute or chronic lower limb wounds through monitoring of concurrent averse events throughout the study duration. This will be assessed through the frequency of occurrence of device-related events, throughout the patient's participation in the trial

  up to 30 days

• Assessment of the global Performance of the VistaCare® device in standard medical practice

  Assessment of the global performance of the VistaCare® medical device as compared to its labeled performance in the approved indication (wound healing). This will be assessed through a global clinical assessment by the investigator of the wound improvement condition throughout the study visits, measured in 3 grades ranging from Aggravation (worst assessment), through Static (no improvement) to Improved (best assessment), taking into consideration the wound healing stage and general clinical condition per investigator's assessment.

  up to 30 days

Secondary Outcomes (6)

• Assessment of time under VistaCare treatment till secondary treatment decision

  up to 15 days

• Wound surface calorimetric assessment of wound status

  30 days

• Safety assessment of the VistaCare® treatment through monitoring of the frequency of adverse events

  throughout 30 days

• TcPO2 assessment

  up to 30 days

• Quality of Life assessments

  throughout 30 days

Study Arms (1)

single cohort of up to 30 patients

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

Device: VistaCare®

Interventions

VistaCare® DEVICE

Controlled atmosphere wound healing device

single cohort of up to 30 patients

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)
• wound location incompatible with VistaCare
• 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

Sponsors & Collaborators

• DTAMedical SAS: lead

Study Sites (5)

CHU Henri Mondor

Créteil, 94010, France

Location

Hôpital La Timone

Marseille, 13005, France

Location

Hôpital de la Conception

Marseille, 13385, France

Location

Hôpital La Timone

Marseille, 13385, France

Location

CHU de Nantes Centre des Brûlés

Nantes, 44093 Cedex 01, France

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Dominique Casanova, MD Pr

  Hôpital de la Conception, Marseille, France

  PRINCIPAL INVESTIGATOR

• Regis Legré, MD Pr

  Hôpital de la Timone, Marseille, France

  PRINCIPAL INVESTIGATOR

• Pierre-Edouard Magnan, MD Pr

  Hôpital de la Timone, Marseille, France

  PRINCIPAL INVESTIGATOR

• Pascal Desgranges, MD Pr

  CHU Henri Mondor, Créteil, France

  PRINCIPAL INVESTIGATOR

• Franck Duteille, MD Pr

  CHU Nantes, France

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: December 31, 2018
• Study Start: February 18, 2019
• Primary Completion: December 31, 2020
• Study Completion: February 1, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)