Non-Healing Ulcer of SkinNCT05739149
A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers
A study testing Microvessel Ultrasound Examination and Skin Biopsy in people with Non-Healing Ulcer of Skin and Non-healing Wound, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Healing Ulcer of Skin, Non-healing Wound, Lower Extremity Wound
- What is being tested?
- Microvessel Ultrasound Examination and Skin Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Ankle-brachial index (ABI) < 0.
- Pregnancy
- Known allergy to lidocaine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Michael R Moynagh, M.B.B.CH, 507-288-2763, Moynagh.Michael@mayo.edu
About this study
Official title: Microvessel Ultrasound Imaging of the Skin and Subcutaneous Tissues to Evaluate Wound Healing in Patients With Chronic Ulcers
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.
- Being tested
- Microvessel Ultrasound Examination, Skin Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microvessel Ultrasound ExaminationDiagnostic test
Ultrasound to evaluate microvessel formation and elastography or stiffness of the tissues around the ulcer and in an area of unaffected skin
Skin BiopsyProcedure or surgery
Dermatology will remove a small piece of skin from the affected ulcer area and control skin
| Study group | Role | What they receive |
|---|---|---|
| Microvessel Ultrasound Imaging for Chronic Ulcers | Experimental | 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 Receives: Diagnostic Test: Microvessel Ultrasound Examination; Procedure: Skin Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvessel imaging
Number of subject's microvessel imaging results that correlate to the standard of care clinical assessment of wound healing
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Dec 2023
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Healing Ulcer of SkinStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael R. Moynagh, Mayo Clinic
- Investigators
- Michael Moynagh, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739149
- Sponsor's protocol ID
- 21-012021
- Status last verified
- Jan 2026
- First submitted
- 13 Feb 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvessel Ultrasound Imaging of the Skin and Subcutaneous Tissues to Evaluate Wound Healing in Patients With Chronic Ulcers
- ClinicalTrials.gov ID
- NCT05739149
- Acronym / sponsor ID
- 21-012021
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microvessel Ultrasound Imaging for Chronic Ulcers | Experimental | Diagnostic Test: Microvessel Ultrasound Examination, Procedure: Skin BiopsySubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microvessel Ultrasound ExaminationUltrasound to evaluate microvessel formation and elastography or stiffness of the tissues around the ulcer and in an area of unaffected skin | Diagnostic test | Microvessel Ultrasound Imaging for Chronic Ulcers |
| Skin BiopsyDermatology will remove a small piece of skin from the affected ulcer area and control skin | Procedure or surgery | Microvessel Ultrasound Imaging for Chronic Ulcers |
Primary outcome
Microvessel imaging
Time frame: 3 months
Number of subject's microvessel imaging results that correlate to the standard of care clinical assessment of wound healing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Moynagh, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microvessel Ultrasound Examination and Skin Biopsy in people with Non-Healing Ulcer of Skin and Non-healing Wound, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael R Moynagh, MD (507-266-4755, moynagh.michael@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvessel imaging (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.