Evaluation Of An Advanced Borderless Dressing

Smith & Nephew

Status: Completed

Conditions: Pressure Ulcer; Diabetic Foot Ulcer; Leg Ulcer

Treatments: Device: Standard Care; Device: ALLEVYN Life Non-Bordered

Study type: Interventional

Funder types: Industry

Identifiers

NCT03146845

CT1603ALF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

ALLEVYN Life Non-Bordered

Experimental group

Description:

Foam Dressing

Treatment:

Device: ALLEVYN Life Non-Bordered

Standard care

Other group

Description:

Standard care dressing

Treatment:

Device: Standard Care