Evaluating ultrasound imaging for wound healing in chronic ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.