A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers

Inclusion criteria

• Chronic venous leg ulcer (CEAP Clinical classification of 6)

• Confirmed, actively managed venous reflux
• No exposed tendon or bone
• Ulcer is >4 weeks in duration
• Ulcer surface area between 2cm2 and 80cm2
• ABI ≥ 0.8
• 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 treatment of the ulcer for the duration of the study, unless medically necessary
• The patient agrees to abstain from enrolment in any other 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 requirements (including compression therapy)
• Patients enrolling at any site in France must have an affiliation to a social security scheme

Exclusion criteria

• Study treatment area has exposed bone or tendon
• Poorly controlled diabetes
• Arterial insufficiency (ABI < 0.8)
• Pregnant/lactating females (self-reported or tested, per institutional requirements)
• The patient has an active wound infection requiring antibiotic therapy
• The patient has had a prior surgical treatment of the ulcer within the past 60 days
• The patient has a life expectancy of 1-year or less
• The patient has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma gangrenosum).
• The patient is unable to follow the protocol
• The patient is taking, or has taken in the past 60 days, mycophenolate mofetil or >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 for Irrigation (Hartmann's) solution.
• The patient is a vulnerable or protected adult.
• The patient is unable to provide consent