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

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microvessel Ultrasound Examination
Skin Biopsy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-Healing Ulcer of Skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microvessel Ultrasound Imaging for Chronic Ulcers

Arm 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 13, 2023
Last Updated
September 19, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05739149
Brief Title
A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers
Official Title
Microvessel Ultrasound Imaging of the Skin and Subcutaneous Tissues to Evaluate Wound Healing in Patients With Chronic Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Healing Ulcer of Skin, Non-healing Wound, Lower Extremity Wound

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microvessel Ultrasound Imaging for Chronic Ulcers
Arm Type
Experimental
Arm 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
Intervention Type
Diagnostic Test
Intervention Name(s)
Microvessel Ultrasound Examination
Intervention Description
Ultrasound to evaluate microvessel formation and elastography or stiffness of the tissues around the ulcer and in an area of unaffected skin
Intervention Type
Procedure
Intervention Name(s)
Skin Biopsy
Intervention Description
Dermatology will remove a small piece of skin from the affected ulcer area and control skin
Primary Outcome Measure Information:
Title
Microvessel imaging
Description
Number of subject's microvessel imaging results that correlate to the standard of care clinical assessment of wound healing
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Moynagh, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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