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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-12-10

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Microvessel Ultrasound Imaging for Chronic Ulcers

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

Group Type EXPERIMENTAL

Microvessel Ultrasound Examination

Intervention Type DIAGNOSTIC_TEST

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

Skin Biopsy

Intervention Type PROCEDURE

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

Interventions

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Microvessel Ultrasound Examination

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

Intervention Type DIAGNOSTIC_TEST

Skin Biopsy

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No