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

Non-healing Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05739149
• Other study ID #: 21-012021
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Extremity Wound
• Non-Healing Ulcer of Skin
• Non-healing Wound
• Ulcer
• Wounds and Injuries

Intervention

Diagnostic Test:
• 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

Procedure:
• Skin Biopsy
Dermatology will remove a small piece of skin from the affected ulcer area and control skin

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microvessel imaging	Number of subject's microvessel imaging results that correlate to the standard of care clinical assessment of wound healing	3 months