Clinical trial NCT03146845: Evaluation Of An Advanced Borderless Dressing
Official title: A Pilot Randomized Controlled Trial to Evaluate an Advanced Borderless Dressing (ALLEVYN LIFE Non-Bordered) in the Treatment of Chronic Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Leg Ulcer
Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcer
Pressure Ulcer
Leg Ulcer
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: INCLUSION CRITERIA

1. The subject must provide informed consent to participate in the study.
2. The subject must be eighteen (18) years of age or older.
3. The subject must be willing and able to make all required study visits.
4. The subject must be able to follow instructions and be deemed capable of completing the CWIS questionnaire.
5. The subject must present with a chronic (≥ 4 weeks duration) ulcer which meets all of the following criteria:

   1. 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)
   2. The ulcer is, in the opinion of the Investigator, moderate to highly exuding.
   3. The ulcer would, in the opinion of the Investigator, benefit from a protective dressing.
   4. The ulcer is not infected based on clinical signs/symptoms.
6. 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

1. Contraindications or hypersensitivity to the use of the ALLEVYN LIFE Non-Bordered, comparator, ancillary products, or their components.
2. Participation in the treatment period of another clinical trial within 30 days of Visit 1 or planned participation overlapping with this study.
3. The subject's reference ulcer is being treated with a topical antimicrobial dressing.
4. 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.
5. Subjects who have participated previously in this clinical trial.
6. Subjects with a history of poor compliance with medical treatment.
7. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Primary outcomes:
measure: Change in the Cardiff Wound Impact Schedule-Physical Symptoms of Daily Living (CWIS-PSDL) Scale Score From Baseline to the Week 6 Visit
timeFrame: Baseline through 6 weeks
Secondary outcomes:
measure: 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
timeFrame: PSDL: baseline, 3 and 12 weeks; WB, SL, GQ, and SQ: baseline, 3, 6, and 12 weeks
measure: Ulcer Progression Using Modified Bates-Jensen Wound Assessment Tool (mBWAT) at Baseline, Weeks 3, 6, and 12 - Total Score
timeFrame: Baseline, Weeks 3, 6, and 12
measure: Number of Participants With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
timeFrame: Baseline, Weeks 3, 6, and 12
measure: Number of Participants Per Category of Exudate Amount; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
timeFrame: Baseline, Weeks 3, 6, and 12
measure: Number of Participants Per Category of Undermining; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
timeFrame: Baseline, Weeks 3, 6, and 12
measure: Number of Participants Per Category of Type of Necrotic Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
timeFrame: Baseline, Weeks 3, 6, and 12
measure: Number of Participants by the Amount of Necrotic Tissue Present; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
timeFrame: Baseline, Weeks 3, 6, and 12
measure: Number of Participants With Skin Color Changes of the Surrounding Wound; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
timeFrame: Baseline, Weeks 3, 6, and 12
measure: Number of Participants With Granulation Tissue; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
timeFrame: Baseline, Weeks 3, 6, and 12
measure: Number of Participants With Epithelialization; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results
timeFrame: Baseline, Weeks 3, 6, and 12
measure: Number of Participants With Peri-Wound Changes; Analyzed for Ulcer Progression Assessed by Condition
timeFrame: Baseline, Weeks 3, 6, and 12
measure: Ulcer Progression Assessed by Change From Baseline in Wound Area
timeFrame: Baseline, Weeks 3, 6 and 12
measure: Ulcer Progression Assessed by Change From Baseline in Wound Volume
timeFrame: Baseline, Weeks 3, 6, and 12
measure: Ulcer Progression Assessed by Change From Baseline in Wound Depth
timeFrame: Baseline, Weeks 3, 6, and 12
measure: Number of Participants With Reference Wound Healed
timeFrame: Weeks 3, 6 and 12
measure: Healthcare Resource Use Related to the Reference Ulcer Over 12 Weeks - Number of Dressings Used
timeFrame: Baseline through 12 weeks
measure: Healthcare Resource Use Related to the Reference Ulcer - Type of Dressings Used Per Dressing Change
timeFrame: Baseline through 12 weeks
measure: Healthcare Resource Use - Number and Type of Compression Dressings Used
timeFrame: Baseline through 12 weeks
measure: Healthcare Resource Use - Number of Participants Requiring Hospital Admission
timeFrame: Baseline through 12 weeks
measure: Healthcare Resource Use - Number of Days Participants Required In-Hospital Care
timeFrame: Baseline through 12 weeks
measure: Healthcare Resource Use - Number of Dressing Changes Required for Each Type of Wound Debridement
timeFrame: Baseline through 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Titan Clinical Solutions
state: Arizona
city: Martinez
country: United States
facility: Center for Clinical Research
state: California
city: Sylmar
country: United States
facility: UCLA Medical Center
state: California
city: Shreveport
country: United States
facility: Grace Research Ltd.
state: Louisiana
city: Summit
country: United States
facility: Wound Care Plus, LLC
state: Missouri
city: Fort Worth
country: United States
facility: JPS Health Network
state: Texas
Study officials:
affiliation: Smith & Nephew, Inc.
name: Rachael Winter
role: STUDY_DIRECTOR
References: