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The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds — SPACE  

Diabetic Foot Ulcer Clinical Trial

Official title:
A Study to Demonstrate the Safety and Performance of the Avelle® Negative Pressure Wound Therapy System on Chronic Wounds

Clinical Trial Summary

This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers.

Clinical Trial Description

This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers. The primary objective of the study is to demonstrate the performance and safety of Avelle Negative Pressure Wound Therapy on wound and wound fluid management when used in accordance with the instructions for use. Participation in the study is anticipated to be two weeks. The Avelle™ NPWT System will be used for two weeks and participants will be seen for study visits during this time. Study participants will need to visit the doctor's office up to five times and, at a minimum, will be required to see the health care provider three times, dependent on the condition of the wound. Each visit is anticipated to last for approximately 45 to 60 minutes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05666570
Study type Observational
Source ConvaTec Inc.
Contact
Status Terminated
Phase
Start date May 18, 2022
Completion date March 21, 2023
View Details
See also
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