NCT01729286

Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix

A Multi-Center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold Moist Wound Therapy and Standard of Care Moist Wound Therapy for the Treatment of Chronic Diabetic Foot Ulcers

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without significantly compromised arterial circulation.

Detailed description

This study will be a multi-center, prospective, randomized single-blinded study evaluating the efficacy of PriMatrix MWT versus Standard of Care MWT in achieving complete wound closure of chronic diabetic foot ulcers by 12 weeks (84 days). To measure wound recidivism and changes in functional quality of life, each subject will complete the Cardiff Wound Impact Schedule and the SF-36v2™ at three time points during the study i) at initial screening, ii) at completion of treatment phase, and iii)at 24 weeks (post-randomization). Additionally, the data obtained from the SF-36v2™ will be used in an economic evaluation of the treatment arms.

Conditions

• Foot Ulcer, Diabetic

Interventions

Type	Name	Description
DEVICE	PriMatrix Moist Wound Therapy	sharp debridement, PriMatrix, a dressing regimen that maintains a moist wound healing environment, and offloading
OTHER	Standard of Care Moist Wound Therapy	sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2012-11-20
• Last updated: 2016-10-18

Locations

18 sites across 2 countries: United States, Puerto Rico