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

NCT05739149 | Recruiting FDA Device

• 1 other identifier: 21-012021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Microvessel imaging

  Number of subject's microvessel imaging results that correlate to the standard of care clinical assessment of wound healing

  3 months

Study Arms (1)

Microvessel Ultrasound Imaging for Chronic Ulcers

EXPERIMENTAL

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; Procedure: Skin Biopsy

Interventions

Microvessel Ultrasound Examination DIAGNOSTIC_TEST

Ultrasound to evaluate microvessel formation and elastography or stiffness of the tissues around the ulcer and in an area of unaffected skin

Microvessel Ultrasound Imaging for Chronic Ulcers

Skin Biopsy PROCEDURE

Dermatology will remove a small piece of skin from the affected ulcer area and control skin

Microvessel Ultrasound Imaging for Chronic Ulcers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Michael Moynagh, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael R Moynagh, MD

CONTACT

507-266-4755; moynagh.michael@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)