Actively Recruiting
Microvessel Ultrasound Imaging of the Skin and Subcutaneous Tissues to Evaluate Wound Healing in Patients With Chronic Ulcers
Led by Mayo Clinic · Updated on 2026-01-22
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research explores the use of a high-resolution microvessel ultrasound imaging system to observe scarring and monitor wound healing in patients with chronic ulcers. The study aims to see if treatments affect the number of tiny blood vessels and circulation around the wound, focusing on chronic diabetic and venous ulcers. It is an interventional study led by the Mayo Clinic that does not involve drug phases or masking methods. Participants with chronic diabetic and venous ulcers will receive standard wound care including wound debridement and treatment. During the study, they will undergo research-specific microvessel ultrasound examinations to assess microvessel formation and tissue stiffness near the ulcer and in unaffected skin. Additionally, two skin biopsies will be taken to gather more information about the wound and skin tissue. Participants will be evaluated over a period of three months, during which microvessel imaging is the primary outcome being measured. The study includes monitoring wound healing progress through ultrasound and skin biopsy data. Patients will be assessed for blood glucose control, blood supply to the wound, and other clinical indicators to understand the healing process. Safety and wound status will be regularly checked throughout the study duration.
CONDITIONS
Brief Title
A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Chronic diabetic foot ulcers and/or lower extremity venous ulcers lasting at least 6 weeks
- Wound surface area between 2 and 15 square centimeters without active infection at enrollment
- Less than 50% reduction in wound size after 30 days of standard care
- For venous ulcers, ultrasound showing venous reflux greater than 0.5 seconds
- Good blood sugar control with fasting glucose not more than 110 mg% and HbA1c less than 6.5%
- Adequate blood supply to the wound confirmed by foot tissue oxygen level greater than 30 mmHg for neuropathic wounds
- For ischemic wounds, clinical improvement in blood supply after revascularization
- Ankle-brachial index (ABI) of 0.8 or higher
You will not qualify if you...
- Acute wounds lasting less than 6 weeks
- Active wound infection or current antibiotic treatment
- Current smoker
- For venous ulcers, ultrasound showing venous reflux less than 0.5 seconds
- Poor blood sugar control with fasting glucose higher than 110 mg%
- Poor blood supply to the wound with foot tissue oxygen level less than 30 mmHg for neuropathic wounds
- Ankle-brachial index (ABI) less than 0
- Pregnancy
- Known allergy to lidocaine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive standard wound care including wound debridement and treatment, alongside research microvessel ultrasound examinations and skin biopsies to evaluate wound healing.
Multiple visits for ultrasound imaging and two skin biopsies as part of research assessments
Trial Site Locations
Total: 1 location
1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
M
Michael R Moynagh, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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