A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.

Study Overview
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Brief Summary
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The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. 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 Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

Detailed Description
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This investigation is designed as a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow exuding chronic wound progression for 6 weeks according to local standard of care. Wound progress is a summary endpoint of the total effect of treatment using Mepilex Up as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition. Two indications will be included: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcers (DFU). A total of n=68 participants, approximately 34 per indication, will be recruited at up to 8 centers in the US. There will be a total of seven (7) visits to the investigation site for participants during the treatment period: baseline, followed by weekly visits up to six (6) weeks post baseline. During visits, evaluations will be performed to assess wound progression and status, wound dressing properties, as well as Subject pain, comfort, and quality of life. Safety will be assessed at all visits. One target wound per participant will be included in this investigation.

Official Title
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A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up

Conditions
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Wounds, Wound of Skin, Wound Leg, Wound; Foot, Diabetic Foot Ulcer, Venous Leg Ulcer

Intervention / Treatment
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* Device: Mepilex Up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed consent to participate (including consent for digital imaging) Adult aged ≥18 years Diagnosed with a chronic, exuding VLU or DFU Exudate amount moderate to large Wound size from 3 cm2 to 30 cm2 for VLU and ≥1 cm2 for DFU, as determined by the clinician For VLU: ABPI (within 3 months) > 0.7. If ABPI > 1.4, then big toe pressure > 60 mmHg is required or an alternative measurement verifying normal distal arterial flow For VLU: Willing to be compliant with compression therapy Exclusion Criteria: 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 Patients participating in the DIPLO NBF study Use of wound fillers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: The model is a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow exuding chronic wound progression for 6 weeks according to local standard of care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care with Mepilex Up<br>All Subjects will use a soft, silicone, non-bordered, adhesive, foam dressing called Mepilex Up as the absorbent primary dressing. | Device: Mepilex Up<br>* Mepilex Up is a highly conformable dressing that absorbs both low and high viscous exudates, maintains a moist wound environment and minimises the risk of maceration. The dressing has a Safetac® wound contact layer that is a unique adhesive technology. It minimises pain to patients and trauma to wounds and the surrounding skin at dressing removal. Mepilex Up consists of: a soft silicone wound contact layer (Safetac) a flexible absorbent pad of compressed polyurethane foam an outer polyurethane film which is breathable but waterproof Dressing material content: Silicone, polyurethane<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound progress of the total effect of treatment using Mepilex Up | Wound progress is the total effect of treatment using Mepilex Up 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. | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Percentage wound volume reduction over time (DFUs only) | The percentage wound volume (cm3) reduction over time will be calculated by a formula from the manually assessed wound depth and the digitally assessed wound area. | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| 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. | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| 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%. | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| 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%. | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Change in exudate amount over time | Exudate amount will be captured as a subjective measure from the investigator/designee and assessed as none, scant, small, moderate, or large. | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Change in exudate nature over time | 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. | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Change in peri-wound skin condition over time | 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. The Transepidermal Water Loss, or TEWL, will be an additional variable assessed at every visit for VLU Subjects at a limited number of clinical sites. TEWL measurements will be done using a portable VapoMeter. | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Change in maceration over time | 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. | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Wound/Peri-Wound itch score prior to dressing removal over time (PRO) | 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. | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Wound pain score during dressing wear over time (PRO) | 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. | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Wound pain score related to removal of dressing over time (PRO) | 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. | A maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Trauma to the wound/peri-wound during dressing removal over time | 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. | A maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Primary dressing's ability to be comfortable to wear (PRO) | Subjects will be asked to rate Mepilex Up degree of comfort using a 4-item scale of very poor, poor, good, or very good. | A maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| For VLU: Mepilex Up ability to be comfortable to wear with compression (PRO) | VLU Subjects will be asked to rate Mepilex Up degree of comfort while wearing with compression using a 4-item scale of very poor, poor, good, or very good. | A maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| For DFU: Mepilex Up ability to be comfortable to wear with offloading (PRO) | DFU Subjects will be asked to rate Mepilex Up degree of comfort while wearing with offloading using a 4-item scale of very poor, poor, good, or very good. | A maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Evaluation of Wound Quality of Life (QoL) (PRO) | 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. | A maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Technical Performance (Investigator/designee's evaluation) | Several questions will be asked to evaluate the technical performance properties of Mepilex Up. 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. | A maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Status of dressing during a routine dressing change or complication | The status of Mepilex Up 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. | A maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Pre-compression edema | 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) | A maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Compression removed/changed/applied | Assessment of compression by the investigator/designee will cover: Compression removal (No/Yes) Compression changed/applied (No/Yes) Type of compression used | A maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Compliance with compression | 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). | A maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Offloading Use/Type | The assessment of offloading will cover if it were used (No/Yes) and specification of offloading type by the investigator/designee. | A maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Compliance to offloading | The investigator/designee will evaluate Subject compliance with offloading. Assessment will include being fully compliant (defined as 7 out of 7 days with offloading), moderately compliant (defined as 1 to 3 days without offloading out of 7 days), or not compliant (defined as >3 days without offloading out of 7 days). | A maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Wear time (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 | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Debridement performed | 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) | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Cleansing performed | The following cleansing details will be recorded for each Subject at each visit: Cleansing performed (No/Yes) Type of cleansing agent used | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 
| Evaluation of all reported adverse events and device deficiencies | If any reported adverse events or device deficiencies are reported, an evaluation will take place to determine root cause. | From baseline visit to last follow-up visit, a maximum total treatment period of 44 days or until healed, whichever occurs first. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot Ulcer, Venous Leg Ulcer