A Pilot Randomized Controlled Trial to Evaluate an Advanced Borderless Dressing (ALLEVYN LIFE Non-Bordered) in the Treatment of Chronic Ulcers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 40
- Locations
- 6
- Primary Endpoint
- Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
ALLEVYN Life Non-Bordered
Foam Dressing
Intervention: ALLEVYN Life Non-Bordered (Device)
Standard care
Standard care dressing
Intervention: Standard Care (Device)
Outcomes
Primary Outcomes
Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit
Time Frame: Baseline through 6 weeks
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.
Secondary Outcomes
- Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results(Baseline, Weeks 3, 6, and 12)
- Ulcer Progression Assessed by Change From Baseline in Wound Depth(Baseline, Weeks 3, 6, and 12)
- Healthcare Resource Use - Number and Type of Compression Dressings Used(Baseline through 12 weeks)
- Healthcare Resource Use - Number of Participants Requiring Hospital Admission(Baseline through 12 weeks)
- Healthcare Resource Use - Number of Days Participants Required In-Hospital Care(Baseline through 12 weeks)
- Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results(Baseline, Weeks 3, 6, and 12)
- Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results(Baseline, Weeks 3, 6, and 12)
- 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(PSDL: baseline, 3 and 12 weeks; WB, SL, GQ, and SQ: baseline, 3, 6, and 12 weeks)
- Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results(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(Baseline, Weeks 3, 6, and 12)
- Ulcer Progression Assessed by Change From Baseline in Wound Volume(Baseline, Weeks 3, 6, and 12)
- Healthcare Resource Use Related to the Reference Ulcer Over 12 Weeks - Number of Dressings Used(Baseline through 12 weeks)
- Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score(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(Baseline, Weeks 3, 6, and 12)
- Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results(Baseline, Weeks 3, 6, and 12)
- Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition(Baseline, Weeks 3, 6, and 12)
- Ulcer Progression Assessed by Change From Baseline in Wound Area(Baseline, Weeks 3, 6 and 12)
- Number of Participants With Reference Wound Healed(Weeks 3, 6 and 12)
- Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change(Baseline through 12 weeks)
- Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results(Baseline, Weeks 3, 6, and 12)
- Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement(Baseline through 12 weeks)