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Microvessel Ultrasound Imaging for Chronic Ulcers

This study is looking at a new way to monitor how chronic wounds heal using a special ultrasound. It's called microvessel ultrasound imaging, and it helps doctors see the tiny blood vessels and the stiffness of the skin around your wound. Researchers want to see if this imaging can help understand scarring and how well a wound is healing. You might be able to join if you have a chronic diabetic foot ulcer or a lower extremity (leg or foot) venous ulcer that has lasted at least 6 weeks, is between 2 and 15 square centimeters, and isn't actively infected. The main goal is to measure these microvessels using the ultrasound after 3 months. The study is currently unclear on its recruitment status and plans to enroll 10 participants.

Study design
This is an interventional study, meaning participants will receive specific tests. It is not specified if it's randomized or blinded, and it plans to enroll 10 participants.
What's involved
Participants will undergo a microvessel ultrasound examination and a skin biopsy. The ultrasound will evaluate microvessels and tissue stiffness, and the biopsy will remove a small piece of skin from the ulcer and unaffected areas.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, microvessel imaging, is measured at 3 months, suggesting follow-up for at least this duration.

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NCT05739149

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

Recruiting
NAAges 18+InterventionalSupportive care
Mayo Clinic
~10 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:Microvessel Ultrasound ExaminationSkin Biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Microvessel imaging
Measured over 3 months

Conditions

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

Explore related trials

Diabetic foot ulcerStasis ulcer

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Michael Moynagh, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Michael R Moynagh, MD
[email protected]
507-266-4755
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Microvessel imaging3 months

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