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

Study Overview
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Brief Summary
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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.

Official Title
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Microvessel Ultrasound Imaging of the Skin and Subcutaneous Tissues to Evaluate Wound Healing in Patients With Chronic Ulcers

Conditions
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Non-Healing Ulcer of Skin, Non-healing Wound, Lower Extremity Wound

Intervention / Treatment
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* Diagnostic Test: Microvessel Ultrasound Examination
* Procedure: Skin Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microvessel Ultrasound Imaging for Chronic Ulcers<br>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 | Diagnostic Test: Microvessel Ultrasound Examination<br>* Ultrasound to evaluate microvessel formation and elastography or stiffness of the tissues around the ulcer and in an area of unaffected skin<br>Procedure: Skin Biopsy<br>* Dermatology will remove a small piece of skin from the affected ulcer area and control skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvessel imaging | Number of subject's microvessel imaging results that correlate to the standard of care clinical assessment of wound healing | 3 months |