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Clinical Trial Summary

Determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.


Clinical Trial Description

The primary objective of this study is to determine acceptable progress towards the goal of therapy for a diabetic foot ulcers (DFU) and pressure Injuries/ulcers (PI/PU) wounds when using the Medela Invia Motion Endure NPWT system during 4-week study duration.

Goal of therapy will be defined by the physician according to initial assessment:

Endpoints (dependent on goal of therapy):

- Decrease in wound volume

- Decrease in size of the tunneling area

- Decrease in size of undermining

- Decrease in amount of slough

- Increase in granulation tissue

- The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft.

**Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented**

B. Secondary Objectives

- To evaluate the ease of use from clinicians.

- To evaluate overall satisfaction from clinicians. C. Tertiary Objectives

- Adequate management of the exudate ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03670225
Study type Interventional
Source Medela AG
Contact
Status Completed
Phase N/A
Start date October 16, 2018
Completion date January 30, 2020

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