A Study to Evaluate the Effectiveness of the Avelle™ Negative Pressure Wound Therapy System on Adults with Chronic Wounds
- Conditions
- diabetes-related foot ulcervenous leg ulcerCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemInjuries and Accidents - Other injuries and accidents
- Registration Number
- ACTRN12623000310662
- Lead Sponsor
- Convatec (Australia) Pty Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method