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Microvessel Ultrasound Imaging for Chronic Ulcers

N/A

Recruiting

Led By Michael Moynagh, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Evidence of active infection or on antibiotics

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses ultrasounds to look for scarring and monitor wound healing, to see if treatments improve circulation.

Who is the study for?

This trial is for people with chronic ulcers on their lower extremities that have not healed in at least 6 weeks and are between 2-15 sq. cm in size. Participants must have controlled blood sugar, adequate blood flow to the wound, and no active infections or allergies to lidocaine. Smokers and pregnant individuals cannot participate.

What is being tested?

The study tests a high-resolution microvessel ultrasound imaging system's ability to detect scarring and monitor healing in chronic wounds. It also examines how treatments affect tiny blood vessels and circulation around the wound.

What are the potential side effects?

Potential side effects may include discomfort or minor pain from the ultrasound examination or skin biopsy procedure, as well as possible bruising or bleeding at the biopsy site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a long-lasting wound from diabetes or poor leg circulation that's between 2 and 15 sq. cm large, without any signs of infection.

Select...

My wound has not shrunk by half after 30 days of standard treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently fighting an infection or taking antibiotics.

Select...

My diabetic foot wound has a poor blood supply, confirmed by a TCPO2 test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Microvessel imaging

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Microvessel Ultrasound Imaging for Chronic UlcersExperimental Treatment2 Interventions

Subjects with chronic diabetic ulcers and venous ulcers will undergo wound debridement and treatment as standard of care and receive research microvessel ultrasound examination and two skin biopsies

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Skin Biopsy

2015

Completed Phase 4

~680

0 / 4Eligibility criteria met