CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
ALLEVYN Life Non-Bordered +1 moredevice
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Age 18 years or older
  • ✓Chronic ulcer ≥4 weeks duration: pressure ulcer, non-ischemic diabetic foot ulcer, or leg ulcer (arterial/mixed/venous)
  • ✓Ulcer is moderate to highly exuding
  • ✓Ulcer is non-infected based on clinical signs/symptoms
Key exclusion· 6
  • ✕Contraindications or hypersensitivity to ALLEVYN LIFE Non-Bordered, comparator, ancillary products, or their components
  • ✕Participation in another clinical trial within 30 days of Visit 1 or planned overlapping participation
  • ✕Reference ulcer being treated with topical antimicrobial dressing
  • ✕Skin features (tattoos, skin color, scarring) that could interfere with study assessments per Investigator

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03146845
NCT03146845N/ACompleted
CompareCT.gov

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

Smith & Nephew, Inc.·interventional·Posted May 10, 2017·Updated May 10, 2023

In Brief

A clinical study evaluating ALLEVYN Life Non-Bordered and Standard Care for Pressure Ulcer and 2 related conditions. Completed, enrolled 40 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPressure Ulcer, Leg Ulcer, Diabetic Foot Ulcer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 10, 2017
Enrollment StartJun 15, 2017
Primary CompletionJun 12, 2018
Study CompletionJun 18, 2018
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 9.1 years ago

Interventions

ALLEVYN Life Non-Bordereddevice

Foam Dressing

Standard Caredevice

Foam Dressing