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

Launched by MAYO CLINIC · Feb 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a special type of ultrasound imaging to help doctors better understand how wounds, particularly chronic ulcers on the legs and feet, are healing. The researchers want to see if this imaging can show changes in tiny blood vessels and blood flow around the wound, which may help guide treatment and improve healing outcomes.

To participate in this study, individuals need to be between the ages of 65 and 74 and have a chronic wound, such as a diabetic foot ulcer or a lower leg venous ulcer, that has not shown significant improvement after at least six weeks of standard care. Participants will undergo the ultrasound imaging procedure and will be monitored for their wound healing progress. It’s important to note that those with active infections, smokers, or those who have certain medical conditions may not be eligible for the trial. This study is currently recruiting participants, and being involved may provide valuable insights into their wound healing journey.

Gender

ALL

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