Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

Inclusion Criteria:

- Ankle Brachial Pressure Index (ABI) ≥ 0.80

- Venous insufficiency confirmed by duplex Doppler ultrasound

- Presence of a venous leg ulcer, unresponsive to Standard of Care treatment for at
least 4 weeks and between ≥ 1 cm2 and ≤ 17.1 cm2 at screening; and between ≥ 1 cm2
and ≤ 12cm2 at the Baseline Visit

Exclusion Criteria:

- Target Ulcer has decreased >30% in size from Screening to Baseline

- Documented history of osteomyelitis at the Target Ulcer location within 6 months
preceding the Baseline Visit.

- Patients who are unable to tolerate multi-layer compression therapy.

- Ulcer, which in the opinion of the Investigator is suspicious for cancer.

- Any malignancy within the past 5 years, excluding successfully treated basal cell
carcinoma or squamous cell carcinoma without evidence of metastases.

- History of radiation at the Target Ulcer site in previous 12 months prior to Baseline
Visit.

- Patients with clinically significant claudication

- Current sepsis

- Patients with known history of significantly compromised immunity for any reason
including radiation therapy, chemotherapy or HIV