A Study to Evaluate the Effectiveness of the Avelle® Negative Pressure Wound Therapy System on Adults with Chronic Wounds

Convatec (Australia) Pty Limited0 个研究点目标入组 30 人开始时间: 2023年3月21日最近更新: 2023年3月27日

适应症

试验速览

暂无简介。

•Greater than or equal to 18 years old at the time of consent
•Able and willing to provide informed consent
•Venous insufficiency as classified by CEAP Classification of C6 or C6R or Diabetes-related 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
•One diabetes-related foot ulcer or venous leg ulcer that is amenable to NPWT
•Reliable and available for follow-up
•Low to moderate exudate
•Able to tolerate negative pressure

•Known sensitivities or allergies to components of the Avelle™ Negative Pressure Wound Therapy System, including but not limited to: silicone/acrylic adhesives, sodium carboxymethylcellulose or nylon
•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 hydrogel dressings /petroleum gel/ creams/oil-based products
•Active treatment for cancer or completed within the last 3 months
•Severe malnutrition
•Visible bone/tendon or exposed articular capsule
•Exposed blood vessels
•Clotting disorder
•Malignant wounds
•Systemic infection
•Untreated osteomyelitis
•Participants with HbA1c greater than 10 within the last 3 months
•Wounds greater than 24 months old
•Previous failed NPWT within last 6 weeks on the qualifying wound
•Chronic Kidney Disease score of 5

发起方

Convatec (Australia) Pty Limited