Evaluation Of An Advanced Borderless Dressing

NCT03146845 | Completed Results FDA Device

• 1 other identifier: CT1603ALF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

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.

Conditions

Pressure Ulcer; Leg Ulcer; Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcer; Pressure Ulcer; Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• 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

• 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 With Each Type of Exudate; Analyzed for Ulcer Progression Using mBWAT - Individual Category Results

  Baseline, Weeks 3, 6, and 12

• 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

Study Arms (2)

ALLEVYN Life Non-Bordered

EXPERIMENTAL

Foam Dressing

Device: ALLEVYN Life Non-Bordered

Standard care

OTHER

Standard care dressing

Device: Standard Care

Interventions

ALLEVYN Life Non-Bordered DEVICE

Foam Dressing

ALLEVYN Life Non-Bordered

Standard Care DEVICE

Foam Dressing

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (6)

Titan Clinical Solutions

Phoenix, Arizona, 85013, United States

Location

Center for Clinical Research

Martinez, California, 94553, United States

Location

UCLA Medical Center

Sylmar, California, 91342, United States

Location

Grace Research Ltd.

Shreveport, Louisiana, 71105, United States

Location

Wound Care Plus, LLC

Summit, Missouri, 64086, United States

Location

JPS Health Network

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Pressure Ulcer; Leg Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Limitations and Caveats

A possible limitation of this study might include the broad nature of the standard of care treatment arm; such as, varying from dressing types to antimicrobial therapy used to NPWT, which may have made a standardized comparison to the ALLEVYN Life Non-Bordered dressing difficult to assess thoroughly. Due to the nature of the physical differences in the dressings it was not possible to blind either subjects or the clinicians.

Results Point of Contact

• Title: Judith Horner
• Organization: Smith & Nephew, Inc.

judith.horner@smith-nephew.com

+44 1482 673251

Study Officials

• Rachael Winter

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: June 15, 2017
• Primary Completion: June 12, 2018
• Study Completion: June 18, 2018
• Last Updated: May 10, 2023
• Results First Posted: May 10, 2023

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)