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
This clinical trial is a pivotal, multi-center, controlled, stratified, randomized, parallel-group study, designed to establish the superior effectiveness of the INTEGRA(TM) Dermal Regeneration Template over that of Standard of Care alone, for healing diabetic foot ulcers located distal to the malleolus in subjects with diabetes, neuropathy, and adequate arterial circulation. The Standard of Care therapy in this study is moist wound therapy. For the purpose of this study a moist wound dressing consisting of 0.9% Sodium Chloride gel, a non-adherent foam dressing and an outer gauze wrap will be utilized. Both groups will receive an off-loading/protective device appropriate to the location of the ulcer.
The study will have three phases: Screening/Run-in, Randomization/Treatment and Follow-up.
Subjects are required to meet all of the following criteria for enrollment into the study.
1. A signed and dated informed consent form has been obtained from the subject.
2. Subject is able and willing to comply with study procedures.
3. Subject is male or female and is ≥ 18 years of age.
4. Subject, if female of child-bearing potential, has a negative serum pregnancy test at
5. Subject has Type I or Type II diabetes mellitus.
6. Subject has a glycosylated hemoglobin, HbA1c, ≤ 12%.
7. Presence of at least one DFU that meets all of the following criteria:
a) Ulcer has been diagnosed as a full-thickness neuropathic DFU and is located
distal to the malleolus (excluding ulcers between the toes but including those of
the heel )
b) There is a minimum 2 cm margin between the qualifying study ulcer and any
other ulcers on the specified foot (post-debridement).
c) Ulcer size (area) ≥ 1 cm2 and ≤ 12 cm2 (post-debridement at time of
d) Wagner grade 1 or 2.
e) Depth ≤ 5 mm with no exposed capsule, tendon or bone and no tunneling,
undermining or sinus tracts
f) Duration of the study ulcer is at least 30 days at the time of the screening visit.
Note: If the subject has more than one qualifying DFU, the ulcer designated as the
study ulcer will be at the discretion of the Investigator. Non-study ulcers being
treated during the course of the study can only be treated with moist wound
therapy (SC identified under this study)
8. Subject has adequate vascular perfusion of the affected limb, as defined by at least
one of the following:
a) Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2
b) Toe pressure (plethysmography) > 50 mm Hg
c) TcPO2 > 4
d) Doppler ultrasound (biphasic or triphasic waveforms) consistent with adequate
blood flow to the affected extremity, as determined by the Standard of Care
practices of the Investigator and the site.
9. Subject or responsible caregiver is willing and able to maintain the required offloading
(as applicable for the location of the ulcer) and applicable dressing changes.0 mm Hg