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New treatment option for Non-Healing Ulcer of Skin
Official title A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers
ClinicalTrials.gov ID: NCT05739149
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
See the full eligibility 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...
- 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...
- Ankle-brachial index (ABI) ≥ 0.8
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.