Evaluating ultrasound imaging for wound healing in chronic ulcers
Microvessel Ultrasound Imaging of the Skin and Subcutaneous Tissues to Evaluate Wound Healing in Patients With Chronic Ulcers
This study tests if using special ultrasound images can help track how well chronic ulcers, like diabetic foot ulcers, are healing and how treatment affects blood flow around the wounds.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05739149 on ClinicalTrials.gov |
What this trial studies
This study explores the use of high-resolution microvessel ultrasound imaging to assess scarring and monitor the healing process of chronic ulcers, specifically diabetic foot ulcers and lower extremity venous ulcers. It aims to determine how treatment influences the formation of tiny blood vessels and circulation around the wound. Participants will undergo microvessel ultrasound examinations and skin biopsies to gather data on their wound healing progress.
Who should consider this trial
Good fit: Ideal candidates are individuals with chronic wounds, such as diabetic foot ulcers or venous ulcers, that have not healed significantly after standard care.
Not a fit: Patients with active infections in their wounds or those whose wounds do not meet the specified size and duration criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved monitoring and treatment strategies for patients with chronic ulcers.
How similar studies have performed: Other studies utilizing advanced imaging techniques for wound assessment have shown promise, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic Minnesota — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Michael Moynagh, MD — Mayo Clinic
- Study coordinator: Michael R Moynagh, MD
- Email: moynagh.michael@mayo.edu
- Phone: 507-266-4755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.