Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Macrocure Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers
