Evaluation Of An Advanced Borderless Dressing

Completed · Not applicable

Conditions studied: Pressure Ulcer, Leg Ulcer, Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT03146845

Run by

Smith & Nephew, Inc.

People needed

40

Starts

2017-06-15

Expected to finish

2018-06-18

Last updated by the study team

2023-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Titan Clinical Solutions — Phoenix, Arizona, United States
• Center for Clinical Research — Martinez, California, United States
• UCLA Medical Center — Sylmar, California, United States
• Grace Research Ltd. — Shreveport, Louisiana, United States
• Wound Care Plus, LLC — Summit, Missouri, United States
• JPS Health Network — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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