A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers

Inclusion criteria

• Chronic wound in the course of diabetic foot ulcers and/or lower extremity venous ulcers with duration of at least 6 weeks and the wound surface not less than 2 sq. cm and not greater than 15 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
• Meets criteria for stalled chronic wound defined as less than 50% reduction in wound size after 30 days of standard of care management.
• For chronic venous ulcers, ultrasound demonstrates venous reflux >0.5 seconds
• Satisfactory blood glucose control - fasting not more than 110 mg%, HbA1c <6.5%
• Satisfactory blood supply to the wound verified by the measurement of the oxygen level of the foot tissue (TCPO2 > 30mmHg) in patients with neuropathic etiology of diabetic foot syndrome
• In the case of the patients with the wounds of ischemic component, the condition for qualification is a clinical improvement of the limb's blood supply as a result of the revascularization procedure documented by ultrasound.
• Ankle-brachial index (ABI) ≥ 0.8

Exclusion criteria

• Acute wound with duration less than 6 weeks
• Evidence of active infection or on antibiotics
• Smoker
• For chronic venous ulcers, ultrasound demonstrates venous reflux <0.5 seconds
• Unsatisfactory blood glucose control - fasting more than 110 mg%, HbA1c <6.5%
• Poor blood supply to the wound verified by the measurement of the oxygen level of the foot tissue (TCPO2 < 30mmHg) in patients with neuropathic etiology of diabetic foot syndrome
• Ankle-brachial index (ABI) < 0.
• Pregnancy
• Known allergy to lidocaine