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