The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds

Study Overview
=================
Brief 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. 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.

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

Conditions
-----------------
Diabetic Foot Ulcer, Venous Leg Ulcer

Intervention / Treatment
-----------------
* Device: Avelle NPWT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Venous insufficiency as defined by CEAP Classification of C6 or C6R or Diabetic foot ulcer Stalled wound/failed treatment in the opinion of the investigator. Defined as a wound that has not progressed by more than 30% in the previous 4 weeks 1 qualifying wound which is amenable to NPWT Reliable and available for follow-up Low to moderate exudate Able to tolerate negative pressure >18 years old at the time of consent Able and willing to provide informed consent Exclusion Criteria: Known sensitivities or allergies to components of the Avelle™ Negative Pressure Wound Therapy System Necrotic wounds or wounds with eschar present Wound is too small or too large based on wound dressing (> 1cm2 and < 100cm2) Wound depth >2cm Use of DuoDERM® gel /petroleum gel/ creams/oil-based products Active treatment for cancer or completed within the last 3 months Severe malnutrition in the opinion of the investigator Visible bone/tendon or exposed articular capsule Exposed blood vessels Clotting disorder Malignant wounds Systemic infection Untreated osteomyelitis Patients with HbA1c greater than 9 on Day 0 (Test to be performed within last 3 months) Wounds greater than 12 months old Previous failed NPWT within last 6 weeks on the qualifying wound Active Pregnancy Chronic Kidney Disease score of 5

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Avelle NPWT<br>Avelle Negative Pressure Wound Therapy administered as indicated by the IFU. | Device: Avelle NPWT<br>* wound management therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 14 Days | 
| Rate of Device Related Adverse Events | Assessment of rate of device related adverse events (ADE) associated with the dressings | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ulcer, negative pressure wound therapy