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

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05739149

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Healing Ulcer of Skin Non-healing Wound Lower Extremity Wound	Diagnostic Test: Microvessel Ultrasound Examination Procedure: Skin Biopsy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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

Arm

Intervention/Treatment

Experimental: 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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Minnesota	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Michael Moynagh, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Michael R. Moynagh, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05739149

Other Study ID Numbers:

21-012021

First Posted:

Feb 22, 2023

Last Update Posted:

Feb 22, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Ulcer

Wounds and Injuries

Study Results

No Results Posted as of Feb 22, 2023