Trials / Completed
CompletedNCT03790202
VistaCare® in the Treatment of Wounds of the Lower Extremity
Open Label Assessment of VistaCare® Treatment in Current Medical Practice in Patients With Acute and Chronic Leg Wounds.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (actual)
- Sponsor
- DTAMedical SAS · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VistaCare® | Controlled atmosphere wound healing device |
Timeline
- Start date
- 2019-02-18
- Primary completion
- 2020-12-31
- Completion
- 2021-02-01
- First posted
- 2018-12-31
- Last updated
- 2021-02-02
Locations
5 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03790202. Inclusion in this directory is not an endorsement.