A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers
Non-Healing Ulcer of Skin, Non-healing Wound, Lower Extremity Wound
About this trial
This is an interventional supportive care trial for Non-Healing Ulcer of Skin
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic Minnesota
Arms of the Study
Arm 1
Experimental
Microvessel Ultrasound Imaging for Chronic Ulcers
Subjects with chronic diabetic ulcers and venous ulcers will undergo wound debridement and treatment as standard of care and receive research microvessel ultrasound examination and two skin biopsies