A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Microvessel Ultrasound Examination
Diagnostic testUltrasound to evaluate microvessel formation and elastography or stiffness of the tissues around the ulcer and in an area of unaffected skin
Skin Biopsy
Procedure/SurgeryDermatology will remove a small piece of skin from the affected ulcer area and control skin
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Microvessel Ultrasound Imaging for Chronic UlcersExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Microvessel imaging
Number of subject's microvessel imaging results that correlate to the standard of care clinical assessment of wound healing
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov