A Feasibility Study of the ReGenerCell™ Autologous Cell Harvesting Device for Diabetic Foot Ulcers

Inclusion Criteria: * The patient has stable diabetes mellitus according to investigators clinical judgement * Diabetic foot Ulcer * Groups 1 and 2: Ulcer surface area between 3 cm2 and 100 cm2 (inclusive) * Group 1: 12-24 weeks in duration, no directly visible tendon or bone (University of Texas Ulcer grade 1A) * Group 2: \>3 weeks in duration, University of Texas Ulcer grade 1B, 2A, 2B, 3A, 3B * No superficial skin infection (of the ulcer area) requiring intervention * Adequate offloading and compliance must be achievable * The patient is 18 years of age or older * The patient is willing to complete all follow-up evaluations required by the study protocol * The patient is able to abstain from any other non-standard treatment of the ulcer for the duration of the study, unless medically necessary * The patient agrees to abstain from enrolment in any other interventional clinical trial for the duration of the study * The patient is able to read and understand instructions and give voluntary written informed consent * The patient is able and willing to follow the protocol Exclusion Criteria: * Patients requiring intervention for Peripheral Arterial Disease (PAD) will be excluded from this study * Severe Peripheral Arterial Disease that is not reconstructible * Pregnant/lactating females (self-reported or tested, per institutional requirements * Use of non-inert dressings (silver, honey etc.) during the past 10 days * Subjects who have evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis) under active treatment * The patient is known to have a pre-existing active condition that may interfere with wound healing, e.g. malignancy, autoimmune disease, immunocompromised blood borne diseases, the patient has AIDS, is HIV- or Hepatitis-C positive, or currently has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum). * The patient is taking, or has taken in the past 60 days, \>10mg of corticosteroids per day. * The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives * The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate solution. * The patient is a vulnerable or protected adult * The patient is unable to follow the protocol * The patient is unable to provide consent