Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05739149

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

Led by Mayo Clinic · Updated on 2026-01-22

10

Participants Needed

1

Research Sites

157 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chronic wound lasting at least 6 weeks from diabetic foot ulcers and/or lower extremity venous ulcers with wound surface between 2 and 15 sq. cm and no active infection at enrollment
  • Wound shows less than 50% size reduction after 30 days of standard care treatment
  • For venous ulcers, ultrasound shows venous reflux greater than 0.5 seconds
  • Good blood sugar control: fasting glucose not more than 110 mg% and HbA1c less than 6.5%
  • Adequate blood supply to the wound confirmed by foot tissue oxygen level (TCPO2 > 30 mmHg) in neuropathic diabetic foot syndrome patients
  • For wounds with ischemic component, clinical improvement in limb blood supply after revascularization procedure documented by ultrasound
  • Ankle-brachial index (ABI) equal to or above 0.8
Not Eligible

You will not qualify if you...

  • Acute wound duration less than 6 weeks
  • Active wound infection or current antibiotic use
  • Smoking
  • For venous ulcers, ultrasound shows venous reflux less than 0.5 seconds
  • Poor blood sugar control: fasting glucose more than 110 mg% or HbA1c not less than 6.5%
  • Poor blood supply to wound confirmed by foot tissue oxygen level (TCPO2 less than 30 mmHg) in neuropathic diabetic foot syndrome patients
  • Ankle-brachial index (ABI) less than 0
  • Pregnancy
  • Known allergy to lidocaine

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic Minnesota

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

M

Michael R Moynagh, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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