Status:
RECRUITING
A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers
Lead Sponsor:
Mayo Clinic
Conditions:
Non-Healing Ulcer of Skin
Non-healing Wound
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05739149
Start Date
December 1 2023
End Date
December 10 2026
Last Update
January 22 2026
Active Locations (1)
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1
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905