Autologous Skin Substitute for Chronic Leg/Foot Ulcers.

Inclusion criteria: * Have a (arterio) venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), or on foot (not plantar side of the foot) with a surface area ≥ 1.0 cm2 and ≤ 40.0 cm2 * Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence. * Arterial supply adequacy confirmed (ABPI ≥ 0.6 and ≤ 1.3) * Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone. Ulcer depth \< 1 cm * Target ulcer duration ≥ 12 weeks but ≤ 15 years * Acceptable state of health and nutrition * Mobile, at least able to walk with medical walker, and able to return for required treatments and study evaluations Exclusion Criteria: * History of anaphylaxis, serum sickness, or erythema multiforme reaction to bovine serum proteins, gentamycin. * Therapy with another investigational agent within thirty (30) days of Screening, or during the study. * A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic). * Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit. * Refusal of or inability to tolerate compression therapy. * Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit. * History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers). * \>30% change of wound size in 4 weeks or confirmed by historical data * Presence of deep vein thrombosis or contra indication for compression therapy * Severe co-morbidity reducing life expectance to \< 1 year * Use of oral corticosteroids and/or cytostatics \>20 mg/per day; * Severe infection of ulcer, active cellulitis, osteomyelitis * Severe malnutrition * Uncontrolled diabetes mellitus, HbA1c \> 12% (108 mmol/mol) * Anaemia Hb \<6 mmol/l