Evaluation Of An Advanced Borderless Dressing

Study Overview
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Brief Summary
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This study will gather preliminary clinical, health economic, and safety data on the treatment of chronic wounds with the ALLEVYN Life Non-Bordered dressing compared to standard of care treatment when used on a wound.

Detailed Description
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The study is a pilot RCT, which will generate the first comparative clinical, economic, and safety data for use of ALNB in subjects. A small sample of subjects with a range of chronic, moderate to highly exuding ulcer types (LU [arterial/mixed etiology leg ulcers or venous leg ulcers requiring compression therapy], PU, and non-ischemic DFU) will be enrolled and followed for 12 weeks to study the impact on health-related quality of life, ulcer progression and healthcare resource utilization.

Official Title
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A Pilot Randomized Controlled Trial to Evaluate an Advanced Borderless Dressing (ALLEVYN LIFE Non-Bordered) in the Treatment of Chronic Ulcers

Conditions
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Pressure Ulcer, Leg Ulcer, Diabetic Foot Ulcer

Intervention / Treatment
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* Device: ALLEVYN Life Non-Bordered
* Device: Standard Care


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA The subject must provide informed consent to participate in the study. The subject must be eighteen (18) years of age or older. The subject must be willing and able to make all required study visits. The subject must be able to follow instructions and be deemed capable of completing the CWIS questionnaire. The subject must present with a chronic (≥ 4 weeks duration) ulcer which meets all of the following criteria: The ulcer is classified as either: a pressure ulcer a non-ischemic diabetic foot ulcer a leg ulcer (arterial/mixed etiology leg ulcers or venous leg ulcers requiring compression therapy) The ulcer is, in the opinion of the Investigator, moderate to highly exuding. The ulcer would, in the opinion of the Investigator, benefit from a protective dressing. The ulcer is not infected based on clinical signs/symptoms. A subject with a DFU must have an ankle-brachial index (ABI) of 0.7 or greater, as measured within 30 days of the Screening Visit. EXCLUSION CRITERIA Contraindications or hypersensitivity to the use of the ALLEVYN LIFE Non-Bordered, comparator, ancillary products, or their components. Participation in the treatment period of another clinical trial within 30 days of Visit 1 or planned participation overlapping with this study. The subject's reference ulcer is being treated with a topical antimicrobial dressing. Subjects with skin features (e.g. tattoos, skin color, pre-existing scarring) which, in the opinion of the Investigator, could interfere with the study assessments. Subjects who have participated previously in this clinical trial. Subjects with a history of poor compliance with medical treatment. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALLEVYN Life Non-Bordered<br>Foam Dressing | Device: ALLEVYN Life Non-Bordered<br>* Foam Dressing<br>|
| Other: Standard care<br>Standard care dressing | Device: Standard Care<br>* Foam Dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit | The primary objective was to estimate the effect of treatment with ALLEVYN Life Non-Bordered (ALNB) on Health-Related Quality of Life (HRQoL) in subjects with chronic ulcers, measured using the CWIS-PSDL scale, compared to subjects receiving standard care (SC) alone over a 6-week treatment period. The CWIS is a questionnaire to measure the impact of chronic wounds on patient health-related quality of life and identify areas of patient concern. The CWIS-PSDL score is transformed on to a 0-100 scale, where a high score indicates a positive rating. The following calculation is used: CWIS-PSDL = (Sum of PSDL item scores-N_PSDL)/(N_PSDL x 4) ×100, where NPSDL = count of 24 questions completed (experience and stress) PSDL Sub-scores are based on 24 questions (12 items on the extent of the problem and 12 on the associated stress), each graded on a 5-point Likert scale [1-5]) with higher scores indicating a better outcome. | Baseline through 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline CWIS-PSDL Score at 3 and 12 Weeks and CWIS-WB, CWIS-SL, CWIS-GQ, and CWIS-SQ Scores at 3, 6, and 12 Weeks | Assessment of the change over time for the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Score at 3 and 12 weeks; CWIS-Well-Being (WB), CWIS-Social Life (SL), CWIS-Global Quality of Life (GQ), CWIS-Quality of Life Scales (SQ) at 3, 6, and 12 weeks. PSDL, SL, and WB sub-scores are based on 24 (score range 24-120), 14 (score range 14-70), and 7 (score range 7-35) questions, respectively; (each graded on a 5-point Likert scale [1-5]) Higher scores on all CWIS metrics indicate a better outcome. PSDL score = (sum of PSDL item scores - 24)/96 x 100 = calculated score of 0 to 100; e.g., 95-24/96 x 100 = 74 (of a possible 100) WB Score = (sum of WB item scores - 7)/28 x 100 = calculated score of 0 to 100 SL Score = (sum of SL item scores - 14)/56 x 100 = calculated score of 0 to 100 GQ Score = How good is your quality of life = score range 0 to 10 SQ Score = How satisfied are you with your overall quality of life = score range 0 to 10 | PSDL: baseline, 3 and 12 weeks; WB, SL, GQ, and SQ: baseline, 3, 6, and 12 weeks | 
| Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) for an overall wound score at each time point. The mBWAT score combined the sub-scores of mBWAT - a tool that has been in widespread use since the early 1990s. mBWAT scoring: There are 13 categories of assessment with item-level score range of 1 to 5 on a modified Likert scale. Each item is scored for the wound characteristic it describes where 1 indicates least severe and 5 indicates most severe with higher scores indicating a more severe wound status. Scores taken over a period of time can be used to track the progression of the wound healing process. Possible score range from 13 to 65 for the total score. The 13 sub-categories include: Size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization | Baseline, Weeks 3, 6, and 12 | 
| Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the type of wound exudate exhibited at each time point. The tool defines the types of exudate as follows: Bloody = thin, bright red Serosanguinous = thin, watery, pale red to pink Serous = thin, watery, clear Purulent = thin or thick, opaque tan to yellow Foul purulent = thick, opaque yellow to green with offensive odor | Baseline, Weeks 3, 6, and 12 | 
| Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the amount of wound exudate demonstrated at each time point. The tool gives the following category descriptions for amount of exudate: None = wound tissues dry Scant = wound tissues moist; no measurable exudate Small = wound tissues wet; moisture evenly distributed in wound; drainage involves </=25% dressing Moderate = wound tissues saturated; drainage may or may not be evenly distributed in wound; drainage involves >25% to </=75% dressing Large = wound tissues bathed in fluid; drainage freely expressed; may or may not be evenly distributed in wound; drainage involves >75% dressing The tool advises to use a transparent metric measuring guide with concentric circles divided into 4 pie-shaped quadrants to determine percentage of dressing involved with exudate. | Baseline, Weeks 3, 6, and 12 | 
| Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the extent (measurement) of wound undermining at each time point. The tool guidance is as follows: Assess by inserting a cotton-tipped applicator under the wound edge; Advance it as far as it will go without using undue force; Raise the tip of the applicator so it may be seen or felt on the surface of the skin; Mark the surface with a pen; Measure the distance from the mark on the skin to the edge of the wound; Continue process around the wound; Then use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine percent of wound involved. | Baseline, Weeks 3, 6, and 12 | 
| Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for type (appearance) of necrotic tissue at each time point. The tool defines the categories of necrotic tissue type as follows: White/gray non-viable tissue = may appear prior to wound opening; skin surface is white or gray Non-adherent, yellow slough = thin, mucinous substance; scattered throughout wound bed; easily separated from wound tissue Loosely adherent, yellow slough = thick, stringy, clumps of debris; attached to wound tissue Adherent, soft, black eschar = soggy tissue; strongly attached to tissue in center or base of wound Firmly adherent, hard/black eschar = firm, crusty tissue; strongly attached to wound base and edges (like a hard scab) | Baseline, Weeks 3, 6, and 12 | 
| Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the amount of necrotic tissue observed during dressing change at each time point. The tool guidance is to use a transparent metric measuring guide with concentric circles divided into 4 pie-shaped quadrants to help determine percent of wound involved. | Baseline, Weeks 3, 6, and 12 | 
| Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the appearance of skin color changes surrounding the reference wound at each time point. The tool guidance is to assess tissues within 4 cm of wound edge. Dark-skinned persons show the colors bright red and dark red as a deepening of normal ethnic skin color or a purple hue. As healing occurs in dark-skinned persons, the new skin is pink and may never darken. | Baseline, Weeks 3, 6, and 12 | 
| Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the appearance and percentage of granulation tissue in the reference wound at each time point. Granulation tissue is the growth of small blood vessels and connective tissue to fill in full-thickness wounds. Tissue is healthy when bright, beefy red, shiny, and granular with a velvety appearance. Poor vascular supply appears as pale-pink or blanched to dull, dusky red color. | Baseline, Weeks 3, 6, and 12 | 
| Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results | Assessment of ulcer progression by the modified Bates-Jensen Wound Assessment Tool (mBWAT) examining participants for the percentage of reference wound demonstrating epithelialization at each time point. Epithelialization is the process of epidermal resurfacing and appears as pink or red skin. In partial-thickness wounds, it can occur throughout the wound bed as well as from the wound edges. In full-thickness wounds, it occurs from the edges only. Use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to help determine percent of wound involved and to measure the distance the epithelial tissue extends into the wound. The mBWAT 13 categories include: Size, depth, edges, undermining, necrotic tissue type, necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, and epithelialization. | Baseline, Weeks 3, 6, and 12 | 
| Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition | Evaluation of the number of participants demonstrating peri-wound changes in appearance as determined visually by the Investigator; categorized as normal, erythematous, edematous, eczematous, excoriated, macerated, or indurated at each time point. | Baseline, Weeks 3, 6, and 12 | 
| Ulcer Progression Assessed by Change From Baseline in Wound Area | The change from Baseline of the wound area was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound area measurements. | Baseline, Weeks 3, 6 and 12 | 
| Ulcer Progression Assessed by Change From Baseline in Wound Volume | The change from Baseline of the wound volume was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound volume measurements. | Baseline, Weeks 3, 6, and 12 | 
| Ulcer Progression Assessed by Change From Baseline in Wound Depth | The change from Baseline in the wound depth was calculated to assess wound healing measured at each time point. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. A positive value indicated the wound showed an improvement in healing; a negative value indicated the wound showed worsening healing status based on wound depth measurements. | Baseline, Weeks 3, 6, and 12 | 
| Number of Participants With Reference Wound Healed | Assessment of the wound healed status (100% re-epithelialized, no drainage, no need for dressing) was analyzed at each visit to determine the healing status of the ulcer. Analyses were conducted using the last observation carried forward (LOCF) method to account for any missing follow-up visit data. | Weeks 3, 6 and 12 | 
| Healthcare Resource Use Related to the Reference Ulcer Over 12 Weeks - Number of Dressings Used | Analysis of the healthcare resources used related to the reference ulcer included: Number of primary and secondary dressings including use of compression therapy. | Baseline through 12 weeks | 
| Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change | Analysis of the healthcare resources used related to the reference ulcer included: Type of primary and secondary dressings including compression therapy used during each dressing change over the 12-week treatment period based on the size of the ulcer. | Baseline through 12 weeks | 
| Healthcare Resource Use - Number and Type of Compression Dressings Used | Not all enrolled participants required the use of compression dressings. Of those participants who did require a compression dressing, an analysis of the healthcare resources used included the number and type of primary and secondary dressings used in relation to the reference ulcer. | Baseline through 12 weeks | 
| Healthcare Resource Use - Number of Participants Requiring Hospital Admission | Analysis of the healthcare resources used for participants who required a hospital admission related to the reference ulcer. | Baseline through 12 weeks | 
| Healthcare Resource Use - Number of Days Participants Required In-Hospital Care | Analysis of the healthcare resources used related to the reference ulcer included: Time in hospital (number of days spent as an inpatient due to reference ulcer). | Baseline through 12 weeks | 
| Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement | Analysis of the healthcare resources used related to the reference ulcer included: Interventions/procedures related to the reference ulcer (number and type) including debridement of the ulcer. | Baseline through 12 weeks | 

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