A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Microvessel Ultrasound Examination, Skin Biopsy.
- Who it may be relevant to
- Registry conditions: Non-Healing Ulcer of Skin, Non-healing Wound, Lower Extremity Wound. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Microvessel Ultrasound Imaging of the Skin and Subcutaneous Tissues to Evaluate Wound Healing in Patients With Chronic Ulcers
Overview
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.
Interventions
- 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
Primary outcome measures
- Microvessel imaging [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic Minnesota — Rochester
Identifiers
NCT: NCT05739149 · 21-012021