A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing

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.

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.

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.

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%.

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%.

Exudate amount will be captured as a subjective measure from the investigator/designee and assessed as none, scant, small, moderate, or large.

Exudate nature will be captured as a subjective measure from the investigator/designee via the following category descriptive scale: serous, serosanguinous, sanguineous, seropurulent, fibrinous, purulent, hemopurulent, or hemorrhagic.

The change in peri-wound skin condition over time will be assessed by visual assessment (No/Yes) by investigator/designee for maceration, dry skin, erythema/redness, and other peri-wound skin conditions.

Area of wound covered by macerated tissue (%) will be assessed before debridement in cm2 by an independent evaluator assisted by digital software.

The maximal distance (cm) from as close to the wound edge as possible to the end of maceration, assessed from wound photo, taken before debridement, by an independent evaluator assisted by digital software. The area of maceration will be assessed from a wound photo taken before debridement by an independent evaluator assisted by digital software.

The Subject itch severity before dressing removal over time will be assessed at all follow-up visits using the Numerical Rating Scale (NRS). The Subject verbally rates their level of itchiness on a level from 0 to 10, where 0 indicates no itch and 10 is the worst itch.

Subject pain severity during dressing wear over time will be assessed at all follow-up visits using the Numerical Rating Scale (NRS). The Subject verbally rates the pain on a level from 0 to 10, where 0 indicates no pain and 10 is the worst pain.

Subject pain severity at dressing removal will be assessed at all follow-up visits using the NRS scale where the Subject verbally rates the pain on a level from 0 to 10, where 0 indicates no pain and 10 is the worst pain. Any pre-procedural or intra-procedural pain medication administered at the time of dressing removal will be recorded.

Trauma to the wound will be captured via visual judgement by the investigator/desginee using an ordinal scale of none, very slight, moderate, or high. Trauma to the peri-wound skin will be captured via visual judgement by the investigator/designee using the ordinal scale of none, very slight, moderate, or high.

Subjects will be asked to rate the dressing's degree of comfort using a 4-item scale of very poor, poor, good, or very good.

Subjects will be asked to rate the dressing's degree of comfort while wearing with compression using a 4-item scale of very poor, poor, good, or very good.

A Wound-QoL-17 questionnaire will be completed by each Subject to measure the disease-specific, health-related QoL of those with chronic wounds. All items assess impairments within the preceding seven days.

Several questions will be asked to evaluate the technical performance properties of the primary dressing. The following will be assessed by the investigator/designee using no/yes values: 1) Occurrence of strike-through, defined as the inability of the dressing to stay sealed over the wound causing leakage of wound exudate; and 2) Occurrence of product residue in the wound bed or on peri-wound skin after dressing removal. All other properties will be assessed by the investigator/designee using a 4-item scale of very poor, poor, good, very good. These include:

• Ability to absorb exudates with different viscosities,
• Ability to retain exudate,
• Ease of application,
• Ability to conform to the wound during wear,
• Ability to be repositioned during application,
• Inability to adhere to moist wound bed,
• Ability to adhere to healthy, intact skin,
• Ability to stay on during application and use,
• Overall satisfaction with the dressing's properties.

The status of the primary dressing during a routine dressing change or complication will be assessed by the investigator/designee as strike-through, saturated, displaced/slipping, or other. This will be recorded in the Dressing Log.

The specification of any pre-compression edema prior to applying/changing compression therapy will be assessed by the investigator/designee as:

• 0 (no clinical edema)
• 1+ (≤2 mm indentation)
• 2+ (2-4 mm indentation)
• 3+ (4-6 mm indentation)
• 4+ (6-8 mm indentation)

Assessment of compression by the investigator/designee will cover:

• Compression removal (No/Yes)
• Compression changed/applied (No/Yes)
• Type of compression used

The investigator/designee will evaluate Subject compliance with compression. Assessment will include being fully compliant (defined as 7 out of 7 days with compression), moderately compliant (defined as 1 to 3 days without compression out of 7 days), or not compliant (defined as >3 days without compression out of 7 days).

Wear time will be determined from the Subject Dressing Log at each visit by collecting:

• Date of dressing application/change
• Reason for change application/change
• Lot/batch
• Size
• Quantity

The following debridement details will be recorded for each Subject at each visit:

• Debridement performed (No/Yes)
• Debridement method
• Ease of debridement (Very easy/Easy/Difficult/Very Difficult)

The following cleansing details will be recorded for each Subject at each visit:

• Cleansing performed (No/Yes)
• Type of cleansing agent used

If any reported adverse events or device deficiencies are reported, an evaluation will take place to determine root cause.