This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers.
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 Type
OBSERVATIONAL
Wound Management Therapy
Convatec Medical Care
Bogota, Cundinamarca, Colombia
The reduction in wound size of the target wound between baseline and end of study
Area reduction will be assessed by measuring the wound area at Day 0, Day 6 (+/- 1 day), and Day 7 (+/- 1 day)
Time frame: 14 days
Wound Healing Status
Assessment of wound progression between baseline and 14 day visit. Wounds will be assessed as healed or progressing towards healing by the investigator.
Time frame: 14 days
Assessment of Skin
Assessment of condition of surrounding skin and signs of infection around the wound using a standardized wound assessment tool (as captured within study database)
Time frame: 14 Days
Rate of Device Related Adverse Events
Assessment of rate of device related adverse events (ADE) associated with the dressings
Time frame: 14 days
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