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

Inclusion Criteria:

1. Chronic venous leg ulcer (CEAP Clinical classification of 6)

   • Confirmed, treated venous reflux
   • No exposed tendon or bone
   • Ulcer is >4 weeks in duration
   • Ulcer surface area between 2cm2 and 80cm2
2. ABI ≥ 0.8
3. The patient is 18 years of age or older
4. The patient is willing to complete all follow-up evaluations required by the study protocol
5. The patient is able to abstain from any other treatment of the ulcer for the duration of the study, unless medically necessary
6. The patient agrees to abstain from enrollment in any other clinical trial for the duration of the study
7. The patient is able to read and understand instructions and give voluntary written informed consent
8. The patient is able and willing to follow the protocol requirements (including compression therapy)

Exclusion Criteria:

1. Study treatment area has exposed bone or tendon
2. Poorly controlled diabetes
3. Arterial insufficiency (ABI < 0.8)
4. Pregnant/lactating females (self-reported or tested, per institutional requirements)
5. Subjects who have evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis) under active treatment
6. The patient has an active wound infection requiring antibiotic therapy
7. The patient has had a prior surgical treatment of the ulcer
8. The patient is known to have a pre-existing 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).
9. The patient is unable to follow the protocol
10. The patient is taking medication known to have an effect on wound healing (e.g., corticosteroids)
11. The patient has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
12. The patient has a known hypersensitivity to trypsin or compound sodium lactate.