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Sound Wave Therapy for Diabetic Foot Ulcers
Study Summary
This trial is testing whether a sound wave device can help heal diabetic foot ulcers. The device has not been approved for this use, so it is considered investigational. The trial will compare the device to a sham device to see if it is more effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have had an ulcer in the same spot as my current one before.I have an active skin infection near my target ulcer.My wound is oozing pus or smells bad.I have been diagnosed with peripheral vascular disease needing surgery.You are very obese, with a body mass index of 40 or higher.I am using effective birth control and my pregnancy test is negative.My kidneys are not working well (creatinine clearance <=40 mL/min).I had surgery to improve blood flow in my legs within the last 8 weeks.I have an active Charcot foot condition.I had surgery to fix a physical abnormality less than 8 weeks ago.I have a foot ulcer below my ankle that has lasted for over 30 days.I have diabetes with an HbA1c level of 11% or less.My ulcer is between 1.0 and 16 cm2 in size.I have a bone infection in my foot or ankle where my ulcer is.I have sickle cell anemia.My leg's blood flow measurements are within the required range.I have not had specific treatments for my ulcer in the last two weeks.I was hospitalized for a serious infection within the last three months.My wound has a deep track that can't be seen from the surface.I have taken immunosuppressants within the last 60 days.I have been treated with cell therapy for my ulcer within the last 60 days.I have been treated with a collagen-based product for my ulcer within the last 30 days.I am 22 years old or older.I am a woman who cannot become pregnant due to surgery or being postmenopausal for at least one year.My diabetic foot ulcer is mild to moderate.I have foot ulcers close together or connected by tunnels.I am taking 10 mg or more of steroids daily.I have had a blood clot in a deep vein within the last six months.I have had radiation treatment in the last 4 months.I have had chemotherapy in the last 60 days.You are not expected to live more than 2 years.You have used drugs or alcohol within the last 120 days.I plan to have a treatment or procedure that is not allowed in the study.I can take care of my wounds at home.I have swelling due to lymphedema.I need a special boot for my foot, but not because of an ulcer on the bottom of my foot.You have previously taken part in a study for dermaPACE treatment of diabetic foot ulcers.My ulcer has shrunk by half or more since my last visit.I have a known immunodeficiency disorder such as AIDS or HIV.I haven't had cancer in the last 5 years, except for treated basal cell carcinoma.
- Group 1: Active device plus standard of care
- Group 2: Sham device plus standard of care
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the Active device plus standard of care most commonly used to treat patients?
"The Active device plus standard of care intervention has undergone multiple rounds of testing, meaning that there is a significant amount of safety data. This, in turn, gives the Active device plus standard of care a score of 3."
Are there many different medical clinics testing this new medication within the state?
"If you are interesting in enrolling in this trial, know that there are 19 different sites currently participating. These locations include Oakland, Hialeah and San Bernardino; to name a few. If you want to limit your travel, it might be best to select the site that is nearest to your home."
Are enrollment numbers still high for this test program?
"This clinical trial is not actively recruiting patients at this time. However, it is worth noting that the trial was originally posted on 2013-03-01 and was last edited on 2014-03-04. Additionally, there are 396 other studies presently enrolling patients."
Who else is applying?
What portion of applicants met pre-screening criteria?
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