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

Not Applicable

Completed

Conditions: Neuropathic Diabetic Ulcer - Foot

Interventions: Other: Conventional Wound Therapy
Device: Integra® Dermal Regeneration Template

Registration Number: NCT01060670

Lead Sponsor: Integra LifeSciences Corporation

Brief Summary: The objective of this study is to evaluate the safety and efficacy 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 545

Inclusion Criteria

Type I or Type II diabetes mellitus
Glycosylated hemoglobin, HbA1c, ≤ 12%
Negative serum pregnancy test at screening for female participants of child-bearing potential
Willing and able to maintain the required off-loading (as applicable for the location for the ulcer) and applicable dressing changes
At least one DFU that met the following criteria:
1. Ulcer was diagnosed as a full-thickness neuropathic DFU that was located distal to the malleolus (excluding ulcers between the toes but including those of the heel),
2. Minimum 2-cm margin between the qualifying study ulcer and any other ulcers on the specified foot (post debridement),
3. Area greater than or equal to 1 square centimeter and less than or equal to 12 square centimeters (post debridement at the time of randomization),
4. Wagner grade 1 or 2,
5. Depth less than or equal to 5 millimeters with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts,
6. Duration of the study ulcer was at least 30 days at the time of the screening visit
Adequate vascular perfusion of the affected limb

Exclusion Criteria

Suspected or confirmed signs/symptoms of gangrene or wound infection on any part of the limb
History of hypersensitivity to bovine collagen and/or chondroitin.
Pregnancy
Previous treatment under this clinical protocol
Participation in another clinical trial involving a device or systematically administered investigational study drug or treatment within 30 days of the randomization visit.
Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing
Any unstable condition or circumstance that could interfere with treatment regimen compliance
Excessive lymphedema that could interfere with wound healing
Unstable Charcot foot or Charcot with boney prominence
Ulcers secondary to a disease other than diabetes
Osteomyelitis with necrotic soft bone
Chopart amputation
History of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or chemotherapy within the 12 months prior to randomization
Treatment with wound dressings that include growth factors, engineered tissues, or skin substitutes within 30 days of randomization or scheduled to receive such treatment during the study
Non-study ulcer requiring treatment that could not be treated during the study with moist wound therapy
History of or intercurrent illnesses or conditions (other than diabetes) that would compromise the safety of the subject, or the normal wound healing process
Employees or relatives of any member of the investigational site or sponsor
Size of the study ulcer following debridement decreased by more than 30% during the run in period

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moist Wound Therapy	Conventional Wound Therapy	0.9% Saline gel
Dermal Replacement Device	Integra® Dermal Regeneration Template	Device: INTEGRA® Dermal Regeneration Template

Primary Outcome Measures

Name	Time	Method
Incidence of Complete Wound Closure	16 weeks	100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.

Secondary Outcome Measures

Name	Time	Method
Incidence of Ulcer Recurrence	12 weeks	Measures the incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.
Change in Short Form Health Survey (SF-36) Quality of Life Metrics	Baseline and 16 weeks	Short Form Health Survey (SF-36)- Quality of Life Metrics. The SF-36 was utilized and the Physical Function and Bodily Pain subscales were norm-based, with a Mean = 50, SD = 10. Scores could theoretically range from 0 to 100, with higher scores indicating a better health status.
Time to Complete Wound Closure	16 weeks	Time to complete wound closure, as assessed by computerized planimetry.
Rate of Wound Closure	16 weeks	Rate of wound closure as assessed by computerized planimetry
Incidence of Complete Wound Closure	16 weeks	Percentage of subjects with complete wound closure of the study ulcer, as assessed by computerized planimetry, during the treatment phase.

Trial Locations

Locations (32): Advanced Foot Care and Clinical Research Center
🇺🇸
Fresno, California, United States
Benchmark Research
🇺🇸
Metarie, Louisiana, United States
Montana Medical Research
🇺🇸
Missoula, Montana, United States
Cambridge Health Alliance
🇺🇸
Cambridge, Massachusetts, United States
Temple University School of Podiatric Medicine
🇺🇸
Philadelphia, Pennsylvania, United States
Limb Salvage Center
🇺🇸
Dallas, Texas, United States
Department of Plastic Surgery
🇺🇸
Dallas, Texas, United States
Penn North Center For Advanced Wound Care
🇺🇸
Erie, Pennsylvania, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Excelsior Foundation of WNY
🇺🇸
Amherst, New York, United States
Private Practice
🇺🇸
East Setauket, New York, United States
Western Pennsylvania Hospital
🇺🇸
Pittsburg, Pennsylvania, United States
St. Elisabeth's Hospital
🇳🇱
Willemstad, Curacao, Netherlands Antilles
Foot and Ankle Institute
🇺🇸
St. George, Utah, United States
Infectious Disease of Indiana
🇺🇸
Indianapolis, Indiana, United States
University of Texas Health Science Center at San Antonio
🇺🇸
San Antonio, Texas, United States
Advanced Foot and Ankle Center
🇺🇸
Las Vegas, Nevada, United States
Costal Clinical Research
🇺🇸
Mobile, Alabama, United States
Stockdale Podiatry Group
🇺🇸
Bakersfield, California, United States
Center for Clinical Research
🇺🇸
Fresno, California, United States
Diabetic Foot and Wound Treatment Center
🇺🇸
El Centro, California, United States
Sacramento Foot and Ankle Center
🇺🇸
Fair Oaks, California, United States
California School of Podiatry Medicine at Samuel Merritt University
🇺🇸
Oakland, California, United States
South Florida Wound Care Group
🇺🇸
Tamarac, Florida, United States
C/O Center for Wound Care
🇺🇸
Wellington, Florida, United States
Bay Pines VA Healthcare System
🇺🇸
Bay Pines, Florida, United States
Advanced Pharma CR, LLC
🇺🇸
Miami, Florida, United States
Village Podiatry Center
🇺🇸
Atlanta, Georgia, United States
Idaho Falls Infectious Diseases, PLLC
🇺🇸
Idaho Falls, Idaho, United States
Springfield Clinic
🇺🇸
Springfield, Illinois, United States
Boston Medical Center
🇺🇸
Boston, Massachusetts, United States
Northern California Foot and Ankle Center
🇺🇸
Santa Rosa, California, United States