UNASSIGNED: Individuals with @entity6 are at an increased risk of developing a @entity4760 ( @entity4760 ). This study evaluated the safety and efficacy of Integra   @entity7674 (IDRT) for the treatment of non-healing DFUs. The FOot Ulcer New DErmal Replacement (FOUNDER) Study was a multi-center, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption (IDE). Thirty-two sites enrolled and randomized 307 subjects with at least one @entity4760 . Consented @entity1 were entered into the 14-day run-in phase where they were treated with the standard of care (0.9% @entity2827 gel) plus a secondary dressing and an offloading/protective device. @entity1 with less than 30% re-epithelialization of the study ulcer after the run-in phase were randomized into the treatment phase. The subjects were randomized to the control treatment group (0.9% @entity2827 gel; n = 153) or the active treatment group (IDRT, n = 154). The treatment phase was 16 weeks or until confirmation of complete wound closure (100% re-epithelialization of the wound surface), whichever occurred first. Following the treatment phase, all subjects were followed for 12 weeks. Complete @entity4760 closure during the treatment phase was significantly greater with IDRT treatment (51%) than control treatment (32%; p=0.001) at sixteen weeks. The median time to complete @entity4760 closure was 43 days for IDRT subjects and 78 days for control subjects in wounds that healed. The rate of wound size reduction was 7.2% per week for IDRT subjects versus 4.8% per week for control subjects (p=0.012). For the treatment of chronic DFUs, IDRT treatment decreased the time to complete wound closure, increased the rate of wound closure, improved components of quality of life and had less adverse events compared to the standard of care treatment. IDRT could greatly enhance the treatment of non-healing DFUs. This article is protected by copyright. All rights reserved.

A Clinical Trial of Integra   Template for XXXX Ulcer Treatment.

@entity1 :: ('9606', 'Species') :: ['patients', 'Patients'] @entity7674 :: ('MESH:D016136', 'Disease') :: ['Dermal Regeneration Template'] @entity6 :: ('MESH:D003920', 'Disease') :: ['diabetes mellitus'] @entity2827 :: ('MESH:D012965', 'Chemical') :: ['sodium chloride'] @entity4760 :: ('MESH:D017719', 'Disease') :: ['diabetic foot ulcer', 'DFU']
@entity6 :: (MESH:D003920,Disease) :: ['Diabetic Foot']
