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

Foot Ulcer, Diabetic Clinical Trial

— HEALED  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01729286
• Other study ID #: TEI-007
• Status: Terminated
• Phase: N/A
• First received: November 13, 2012
• Last updated: October 14, 2016
• Start date: September 2012
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 92
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type I or Type II diabetes

• A diabetic foot ulcer located on the foot or ankle at least one square centimeter

Exclusion Criteria:

• Suspected or confirmed signs/symptoms of wound infection

• Hypersensitivity to bovine collagen

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Puerto Rico	Centro Podiatrico del Norte	Arecibo
Puerto Rico	Renier Gonzalez-Cruz	Juana Diaz
Puerto Rico	VA Carribean Healthcare System	San Juan
United States	Joseph M. Still Research Foundation	Augusta	Georgia
United States	American Health Network	Carmel	Indiana
United States	Imperial Health	Lake Charles	Louisiana
United States	North Shore Long Island Jewish Comprehensive Wound Healing Center	Lake Success	New York
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Foot and Ankle Clinic	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	University of Tennessee	Memphis	Tennessee
United States	Advanced Research Institute of Miami	Miami	Florida
United States	Foot & Andle Center of Mooresville	Mooresville	Indiana
United States	Kansas City Vascular	North Kansas City	Missouri
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	St. Anthony's Medical Center	St. Louis	Missouri
United States	Advanced Foot & Ankle Specialists	Tampa	Florida
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete wound closure		by 12 weeks	No
Secondary	Change in predicted medical expenditures between PriMatrix and Standard of Care		over 24 weeks	No
Secondary	Change in quality of life measurements between PriMatrix and Standard of Care		between baseline and 24 weeks	No
Secondary	Nonserious and serious adverse events		over 24 weeks	Yes