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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-healing Wound; Lower Extremity Wound; Non-Healing Ulcer of Skin
• Intervention / Treatment: Diagnostic test: Microvessel Ultrasound Examination; Procedure: Skin Biopsy

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael R Moynagh, MD; Phone Number: 507-266-4755; Email: moynagh.michael@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Minnesota
      • Contact: Michael R Moynagh, M.B.B.CH; Phone Number: 507-288-2763; Email: Moynagh.Michael@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Diagnostic test: Microvessel Ultrasound Examination; Ultrasound to evaluate microvessel formation and elastography or stiffness of the tissues around the ulcer and in an area of unaffected skin; Procedure: Skin Biopsy; Dermatology will remove a small piece of skin from the affected ulcer area and control skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microvessel imaging	Number of subject's microvessel imaging results that correlate to the standard of care clinical assessment of wound healing	3 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Michael Moynagh, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 10, 2026

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ulcer; Wounds and Injuries
• Other Study ID Numbers: 21-012021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No