NCT03146845

Evaluation Of An Advanced Borderless Dressing

A Pilot Randomized Controlled Trial to Evaluate an Advanced Borderless Dressing (ALLEVYN LIFE Non-Bordered) in the Treatment of Chronic Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pressure Ulcer
• Leg Ulcer
• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	ALLEVYN Life Non-Bordered	Foam Dressing
DEVICE	Standard Care	Foam Dressing

Timeline

• Start date: 2017-06-15
• Primary completion: 2018-06-12
• Completion: 2018-06-18
• First posted: 2017-05-10
• Last updated: 2023-05-10
• Results posted: 2023-05-10

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study