Status:

RECRUITING

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

Lead Sponsor:

Mayo Clinic

Conditions:

Non-Healing Ulcer of Skin

Non-healing Wound

Eligibility:

All Genders

18+ years

Phase:

NA

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...

Eligibility Criteria

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

Key Trial Info

Start Date :

December 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 10 2026

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT05739149

Start Date

December 1 2023

End Date

December 10 2026

Last Update

January 22 2026

Active Locations (1)

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1

Mayo Clinic Minnesota

Rochester, Minnesota, United States, 55905

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