The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds

Terminated

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Avelle NPWT	Avelle NPWT	Avelle Negative Pressure Wound Therapy administered as indicated by the IFU.

Primary Outcome Measures

Name	Time	Method
The reduction in wound size of the target wound between baseline and end of study	14 days	Area reduction will be assessed by measuring the wound area at Day 0, Day 6 (+/- 1 day), and Day 7 (+/- 1 day)

Secondary Outcome Measures

Name	Time	Method
Wound Healing Status	14 days	Assessment of wound progression between baseline and 14 day visit. Wounds will be assessed as healed or progressing towards healing by the investigator.
Assessment of Skin	14 Days	Assessment of condition of surrounding skin and signs of infection around the wound using a standardized wound assessment tool (as captured within study database)
Rate of Device Related Adverse Events	14 days	Assessment of rate of device related adverse events (ADE) associated with the dressings

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