Lower Extremity Wound, Non-Healing Ulcer of Skin, Non-healing Wound
Conditions
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.
Interventions
PROCEDURESkin Biopsy
Dermatology will remove a small piece of skin from the affected ulcer area and control skin
DIAGNOSTIC_TESTMicrovessel Ultrasound Examination
Ultrasound to evaluate microvessel formation and elastography or stiffness of the tissues around the ulcer and in an area of unaffected skin
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microvessel imaging | 3 months | Number of subject's microvessel imaging results that correlate to the standard of care clinical assessment of wound healing |
Countries
United States
Contacts
CONTACTMichael R Moynagh, MD
PRINCIPAL_INVESTIGATORMichael Moynagh, MD
Mayo Clinic
Outcome results
None listed