The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit.
Participants will be asked to wear the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.
Signed consent to participate (including consent for digital imaging)
Adult aged ≥18 years
Diagnosed with a chronic, exuding VLU
Exudate amount moderate to large
Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment
Circumferential wound
Known allergy/hypersensitivity to the materials of the dressing
Use of wound fillers
Single group
ALLEVYN Non-Adhesive
DeviceALLEVYN Non-Adhesive combines patient comfort with the tri-layer fluid management system that enables moist wound healing. It utilizes a unique triple action technology that manages fluid to maintain optimal moist wound healing conditions. It is ideal for fragile and sensitive skin due to its non-adherent wound contact layer and soft and conformable construction. ALLEVYN Non-Adhesive consists of the following layers: * Breathable top film * Highly absorbent foam core * Non-adhesive wound contact layer
Wound progress of the total effect of treatment using ALLEVYN Non-Adhesive
Wound progress is the total effect of treatment using ALLEVYN Non-Adhesive as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition by the treating investigator/designee. Wound progress will be assessed as deteriorated, no change, improved, or healed at each visit. Wound area will be measured by an independent evaluator assisted by digital software at each visit and recorded as cm2 using the formula, A= π\*L\*W/4.
Percentage wound area reduction over time
The percentage of wound area (cm2) reduction over time will be assessed by a formula as the area of an ellipse and measured by an independent evaluator assisted by digital software on all digital photographs taken at each scheduled visit.
Linear wound healing over time
The linear wound healing will be calculated with Gilman's formula (cm/day), G = - (A1-A0)/ {\[(P1+P0)/2\]\*(t1-t0)}, where: A0 = previous visit area A1 = current visit area P0 = previous visit perimeter P1 = current visit perimeter t0 = previous visit time t1 = current visit time. Area (A) and Perimeter (P) will be assessed by an independent evaluator assisted by digital software. Perimeter (P) will be measured in cm and Area (A) will be assessed in cm2.
Change in granulation tissue over time
The area of wound covered by granulation tissue, (%) before and after cleansing/debridement will be assessed as follows: 1) via an independent evaluator assisted by digital software; and 2) via visual judgement by investigator/designee and determined as: None, 1%-24%, 25%-49%, 50%-74%, or 75%-100%.
Change in sloughy tissue over time
The area of wound covered by sloughy tissue, (%) before and after cleansing/debridement will be assessed as follows: 1) via an independent evaluator assisted by digital software; and 2) via visual judgement by investigator/designee and determined as: None, 1%-24%, 25%-49%, 50%-74%, or 75%-100%.
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