Recruiting

Microvessel Ultrasound

Sponsor:

Mayo Clinic

Code:

NCT05739149

Conditions

Non-Healing Ulcer of Skin

Non-healing Wound

Lower Extremity Wound

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Microvessel Ultrasound Examination

Skin Biopsy

Study Details

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

Study ID

NCT05739149

Start date

Dec 1, 2023

Status verified date

Jan, 2026

Completion date

Dec 10, 2026

Anticipated

Primary completion date

Dec 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

Interventions

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

Skin Biopsy

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

Primary outcome measure

  • Microvessel imaging [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Michael R Moynagh, MD

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

Locations

Mayo Clinic Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Michael R Moynagh, M.B.B.CH

507-288-2763Moynagh.Michael@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-22.