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

Mayo Clinic

Status: Enrolling

Conditions: Non-Healing Ulcer of Skin; Lower Extremity Wound; Non-healing Wound

Treatments: Diagnostic Test: Microvessel Ultrasound Examination; Procedure: Skin Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05739149

21-012021

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Microvessel Ultrasound Imaging for Chronic Ulcers

Experimental group

Description:

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

Treatment:

Procedure: Skin Biopsy

Diagnostic Test: Microvessel Ultrasound Examination