NCT05666570

The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: ConvaTec Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetic Foot Ulcer
• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	Avelle NPWT	Wound Management Therapy

Timeline

• Start date: 2022-05-18
• Primary completion: 2022-11-27
• Completion: 2023-03-21
• First posted: 2022-12-28
• Last updated: 2025-12-08

Locations

1 site across 1 country: Colombia

Regulatory

• FDA-regulated device study