VistaCare® in the Treatment of Wounds of the Lower Extremity

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03790202
Study type	Observational
Source	DTAMedical SAS
Contact
Status	Completed
Phase
Start date	February 18, 2019
Completion date	February 1, 2021

View Details

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