The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds

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.

Inclusion Criteria:Venous insufficiency as defined by CEAP Classification of C6 or C6R or Diabetic foot ulcerStalled 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 weeks1 qualifying wound which is amenable to NPWTReliable and available for follow-upLow to moderate exudateAble to tolerate negative pressure>18 years old at the time of consentAble and willing to provide informed consentExclusion Criteria:Known sensitivities or allergies to components of the Avelle™ Negative Pressure Wound Therapy SystemNecrotic wounds or wounds with eschar presentWound is too small or too large based on wound dressing (> 1cm2 and < 100cm2)Wound depth >2cmUse of DuoDERM® gel /petroleum gel/ creams/oil-based productsActive treatment for cancer or completed within the last 3 monthsSevere malnutrition in the opinion of the investigatorVisible bone/tendon or exposed articular capsuleExposed blood vesselsClotting disorderMalignant woundsSystemic infectionUntreated osteomyelitisPatients with HbA1c greater than 9 on Day 0 (Test to be performed within last 3 months)Wounds greater than 12 months oldPrevious failed NPWT within last 6 weeks on the qualifying woundActive PregnancyChronic Kidney Disease score of 5