NCT05739149 A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers
| NCT ID | NCT05739149 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Non-Healing Ulcer of Skin |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-12-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2023-12-01 with a primary completion date of 2026-12-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Michael Moynagh, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT05739149 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Healing Ulcer of Skin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05739149 currently recruiting?
Yes, NCT05739149 is actively recruiting participants. Contact the research team at moynagh.michael@mayo.edu for enrollment information.
Where is the NCT05739149 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05739149 clinical trial?
NCT05739149 is sponsored by Mayo Clinic. The principal investigator is Michael Moynagh, MD at Mayo Clinic. The trial plans to enroll 10 participants.