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

Not Applicable

Recruiting

• Conditions: Non-Healing Ulcer of Skin; Non-healing Wound; Lower Extremity Wound
• Interventions: Diagnostic Test: Microvessel Ultrasound Examination; Procedure: Skin Biopsy

• Registration Number: NCT05739149
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-22
• Study Start: 2023-12-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microvessel Ultrasound Imaging for Chronic Ulcers	Skin Biopsy	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
Microvessel Ultrasound Imaging for Chronic Ulcers	Microvessel Ultrasound Examination	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

Primary Outcome Measures

Name	Time	Method
Microvessel imaging	3 months	Number of subject's microvessel imaging results that correlate to the standard of care clinical assessment of wound healing

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States