A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers

Foot Ulcer, Diabetic Clinical Trial

Official title:

A Multi-Center, Randomized, Controlled Clinical Trial to Evaluate The Safety and Effectiveness of Integra® Dermal Regeneration Template for the Treatment of Neuropathic Diabetic Foot Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060670
• Other study ID #: IDRT/DFU US - 2009-3
• Status: Completed
• Phase: N/A
• First received: January 31, 2010
• Last updated: August 24, 2015
• Start date: April 2010
• Est. completion date: July 2014

Study information

• Verified date: August 2015
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and effectiveness of the INTEGRA® Dermal Regeneration Template for the treatment of diabetic foot ulcers located distal to the malleolus in subjects with diabetes mellitus, neuropathy, and without significantly compromised arterial circulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type I or Type II diabetes mellitus

• Glycosylated hemoglobin, HbA1c, = 12%

• Diabetic foot ulcer located below the ankle and/or on the bottom of the foot which has been present for 30 days and is sufficient size to qualify for the study

• Good vascular perfusion of the affected limb

Exclusion Criteria:

• Gangrene, infection, or osteomyelitis

• Sensitivity to bovine collagen and/or chondroitin.

• Ulcers resulting from other health conditions besides diabetes

• Conditions or laboratory values which are not within the specified ranges

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Integra® Dermal Regeneration Template
Application of Integra® Dermal Regeneration Template in diabetic foot ulcer

Other:
• Conventional Wound Therapy
Conventional Wound Therapy

Locations

Country	Name	City	State
Netherlands Antilles	St. Elisabeth's Hospital	Willemstad	Curacao
United States	Excelsior Foundation of WNY	Amherst	New York
United States	Village Podiatry Center	Atlanta	Georgia
United States	Stockdale Podiatry Group	Bakersfield	California
United States	Bay Pines VA Healthcare System	Bay Pines	Florida
United States	Boston Medical Center	Boston	Massachusetts
United States	Cambridge Health Alliance	Cambridge	Massachusetts
United States	Center for Clinical Research	Castro Valley	California
United States	Department of Plastic Surgery	Dallas	Texas
United States	Limb Salvage Center	Dallas	Texas
United States	Private Practice	East Setauket	New York
United States	Diabetic Foot and Wound Treatment Center	El Centro	California
United States	Penn North Center For Advanced Wound Care	Erie	Pennsylvania
United States	Sacramento Foot and Ankle Center	Fair Oaks	California
United States	Advanced Foot Care and Clinical Research Center	Fresno	California
United States	Center for Clinical Research	Fresno	California
United States	Idaho Falls Infectious Diseases, PLLC	Idaho Falls	Idaho
United States	Infectious Disease of Indiana	Indianapolis	Indiana
United States	Advanced Foot and Ankle Center	Las Vegas	Nevada
United States	Benchmark Research	Metarie	Louisiana
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Montana Medical Research	Missoula	Montana
United States	Costal Clinical Research	Mobile	Alabama
United States	Columbia University Medical Center	New York	New York
United States	California School of Podiatry Medicine at Samuel Merritt University	Oakland	California
United States	Temple University School of Podiatric Medicine	Philadelphia	Pennsylvania
United States	Western Pennsylvania Hospital	Pittsburg	Pennsylvania
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Northern California Foot and Ankle Center	Santa Rosa	California
United States	Springfield Clinic	Springfield	Illinois
United States	Foot and Ankle Institute	St. George	Utah
United States	South Florida Wound Care Group	Tamarac	Florida
United States	C/O Center for Wound Care	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Countries where clinical trial is conducted

United States,  Netherlands Antilles, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complete wound closure		16 weeks	No
Secondary	Time to complete wound closure		28 weeks	No
Secondary	Incidence of recurrence		28 weeks	No
Secondary	Incidence of adverse events		28 weeks	Yes