Clinical trial NCT01060670: A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Diabetic Ulcer - Foot
Keywords: Foot Ulcer
Diabetic
Wound Healing
Integra Dermal Regeneration Template
Full Thickness
Neuropathic
Omnigraft
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Complete Wound Closure
timeFrame: 16 weeks
Secondary outcomes:
measure: Incidence of Complete Wound Closure
timeFrame: 16 weeks
measure: Time to Complete Wound Closure
timeFrame: 16 weeks
measure: Time to Complete Wound Closure
timeFrame: 16 weeks
measure: Rate of Wound Closure
timeFrame: 16 weeks
measure: Incidence of Ulcer Recurrence
timeFrame: 12 weeks
measure: Change in Short Form Health Survey (SF-36) Quality of Life Metrics
timeFrame: Baseline and 16 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Costal Clinical Research
state: Alabama
city: Bakersfield
country: United States
facility: Stockdale Podiatry Group
state: California
city: Castro Valley
country: United States
facility: Center for Clinical Research
state: California
city: El Centro
country: United States
facility: Diabetic Foot and Wound Treatment Center
state: California
city: Fair Oaks
country: United States
facility: Sacramento Foot and Ankle Center
state: California
city: Fresno
country: United States
facility: Advanced Foot Care and Clinical Research Center
state: California
city: Fresno
country: United States
facility: Center for Clinical Research
state: California
city: Oakland
country: United States
facility: California School of Podiatry Medicine at Samuel Merritt University
state: California
city: Santa Rosa
country: United States
facility: Northern California Foot and Ankle Center
state: California
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Tamarac
country: United States
facility: South Florida Wound Care Group
state: Florida
city: Wellington
country: United States
facility: C/O Center for Wound Care
state: Florida
city: Atlanta
country: United States
facility: Village Podiatry Center
state: Georgia
city: Idaho Falls
country: United States
facility: Idaho Falls Infectious Diseases, PLLC
state: Idaho
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Indianapolis
country: United States
facility: Infectious Disease of Indiana
state: Indiana
city: Metarie
country: United States
facility: Benchmark Research
state: Louisiana
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Cambridge
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Las Vegas
country: United States
facility: Advanced Foot and Ankle Center
state: Nevada
city: Amherst
country: United States
facility: Excelsior Foundation of WNY
state: New York
city: East Setauket
country: United States
facility: Private Practice
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Erie
country: United States
facility: Penn North Center For Advanced Wound Care
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University School of Podiatric Medicine
state: Pennsylvania
city: Pittsburg
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Limb Salvage Center
state: Texas
city: Dallas
country: United States
facility: Department of Plastic Surgery
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: St. George
country: United States
facility: Foot and Ankle Institute
state: Utah
city: Willemstad
country: Netherlands Antilles
facility: St. Elisabeth's Hospital
state: Curacao
Study officials:
References: