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Pulsed Acoustic Cellular Expression Device
Sound Wave Therapy for Diabetic Foot Ulcers
Phase 3
Waitlist Available
Research Sponsored by SANUWAVE, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
If female of child-bearing potential, practices one of the following methods of contraception and continues through the duration of the study: hormonal contraceptives, IUD, spermicide and barrier or implantable device, and has a negative urine qualitative beta-HCG pregnancy test
Has at least one DFU that is located in the ankle area or below that has persisted a minimum of 30 days prior to Visit 1
Must not have
Has evidence of a prior ulcer in the same area as the target ulcer
Has active cellulitis either at the site of, or in the surrounding area of, the target ulcer at Visit 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal Trial
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.
Who is the study for?
Adults over 22 with Type I or II Diabetes and a diabetic foot ulcer between 1.0 cm2 and 16 cm2 that's lasted at least 30 days can join this trial. They must have certain blood flow levels in their legs, an HbA1c <=11%, and use contraception if applicable. Exclusions include nursing women, recent deep vein thrombosis patients, those with severe kidney disease or infections near the ulcer, among others.
What is being tested?
The study tests the dermaPACE® device which uses sound waves to potentially help heal diabetic foot ulcers versus a sham (inactive) device. Both are used alongside standard care for ulcers to see if there's a difference in healing speed.
What are the potential side effects?
Potential side effects aren't specified but may include discomfort at the treatment site due to acoustic pressure waves from the dermaPACE® device or issues related to not receiving active treatment with the sham device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using effective birth control and my pregnancy test is negative.
Select...
I have a foot ulcer below my ankle that has lasted for over 30 days.
Select...
I have diabetes with an HbA1c level of 11% or less.
Select...
My ulcer is between 1.0 and 16 cm2 in size.
Select...
My leg's blood flow measurements are within the required range.
Select...
I am 22 years old or older.
Select...
My diabetic foot ulcer is mild to moderate.
Select...
I can take care of my wounds at home.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had an ulcer in the same spot as my current one before.
Select...
I have an active skin infection near my target ulcer.
Select...
My wound is oozing pus or smells bad.
Select...
I have been diagnosed with peripheral vascular disease needing surgery.
Select...
My kidneys are not working well (creatinine clearance <=40 mL/min).
Select...
I have a bone infection in my foot or ankle where my ulcer is.
Select...
I had surgery to improve blood flow in my legs within the last 8 weeks.
Select...
I have an active Charcot foot condition.
Select...
I was hospitalized for a serious infection within the last three months.
Select...
My wound has a deep track that can't be seen from the surface.
Select...
I have taken immunosuppressants within the last 60 days.
Select...
I have had a blood clot in a deep vein within the last six months.
Select...
I have had chemotherapy in the last 60 days.
Select...
I have sickle cell anemia.
Select...
I plan to have a treatment or procedure that is not allowed in the study.
Select...
I have swelling due to lymphedema.
Select...
I have foot ulcers close together or connected by tunnels.
Select...
I am taking 10 mg or more of steroids daily.
Select...
My ulcer has shrunk by half or more since my last visit.
Select...
I have a known immunodeficiency disorder such as AIDS or HIV.
Select...
I haven't had cancer in the last 5 years, except for treated basal cell carcinoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete closure
Secondary study objectives
Area reduction
Volumetric reduction
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active device plus standard of careActive Control1 Intervention
Active device plus standard of care
Group II: Sham device plus standard of carePlacebo Group1 Intervention
dermaPACE device that uses a dummy applicator that does not emit shock waves
Find a Location
Who is running the clinical trial?
SANUWAVE, Inc.Lead Sponsor
2 Previous Clinical Trials
208 Total Patients Enrolled
2 Trials studying Foot Ulcer
208 Patients Enrolled for Foot Ulcer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Active device plus standard of care
- Group 2: Sham device plus standard of care
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.