Microvessel Ultrasound Imaging of the Skin and Subcutaneous Tissues to Evaluate Wound Healing in Patients With Chronic Ulcers

Mayo Clinic1 site in 1 country10 target enrollmentDecember 1, 2023

ConditionsNon-Healing Ulcer of Skin Non-healing Wound Lower Extremity Wound

Overview

Phase: N/A
Intervention: Not specified
Conditions: Non-Healing Ulcer of Skin
Sponsor: Mayo Clinic
Enrollment: 10
Locations: 1
Primary Endpoint: Microvessel imaging
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research is to explore the use of high-resolution microvessel ultrasound imaging system to look for scarring and to monitor wound healing and to see if treatment affects the amount of tiny vessels and circulation around the wound.

Registry

clinicaltrials.gov

Start Date

December 1, 2023

End Date

December 10, 2026

Last Updated

3 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Michael R. Moynagh

Principal Investigator

Mayo Clinic

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
•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) \<
•Pregnancy
•Known allergy to lidocaine