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RecruitingNot ApplicableNCT05739149

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

Sponsor

Mayo Clinic

Enrollment

10 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Non-Healing Ulcer of Skin

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria9

  • 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

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Interventions

DIAGNOSTIC_TESTMicrovessel Ultrasound Examination

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

PROCEDURESkin Biopsy

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

Locations(1)

Mayo Clinic Minnesota

Rochester, Minnesota, United States

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NCT05739149