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

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:

• 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),
• Minimum 2-cm margin between the qualifying study ulcer and any other ulcers on the specified foot (post debridement),
• 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),
• Wagner grade 1 or 2,
• Depth less than or equal to 5 millimeters with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts,
• 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