Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.

Inclusion Criteria: * Subject is ≥18 years of age and has type 1 or 2 diabetes * Texas grade 1a or 2a wound located distal to the malleolus (excluding ulcers between the toes but including those of the heel) and depth ≤ 5 mm with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts * Prior to inclusion of an ulcer in the study, each wound will be reviewed for eligibility by an independent assessor using a central online review process that includes images of the ulcer. * For patients with potentially multiple eligible DFUs, the biggest ulcer will be chosen as the study ulcer. * Ulcer size between 1 cm2 and 12 cm2 (post-debridement). * Ulcer duration of ≥ 30 days. Time 0 for ulcer duration of ≥ 30 days is defined as the first day of screening (i.e., day -14). Subjects will need to meet all inclusion criteria, including lack of ulcer healing until day 0. * Study ulcer separated from other ulcers by at least 2 cm. * Ulcer or affected limb free of clinical signs of infection. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after eradication of the infection). * Post-debridement, ulcer free of necrotic tissue. * 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 \> 40 mm Hg; or (d) skin perfusion pressure (SPP) \> 30 mm Hg. *…