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Shockwave Therapy for Diabetic Foot Ulcers
Study Summary
This trial will compare healing rates of foot ulcers in diabetics receiving standard care vs. standard care + shockwave therapy.
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.Find a Location
Who is running the clinical trial?
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- I have Type I diabetes.I can take care of my wounds at home.I have a disorder that weakens my immune system.I have Type 2 diabetes and may or may not use insulin.I am willing and able to follow all study rules and attend all visits.My ulcer is mild to moderate in severity.My blood protein levels are very low.I can feel a pulse in my foot or have good blood flow there.I have had chemotherapy within the last 2 months.I have not used growth factors, prostaglandin, or vasodilators for my foot ulcer in the last 2 weeks.I am currently taking steroid medication.I have sickle cell anemia.I have more than one ulcer on my foot.I need vascular surgery for my peripheral vascular disease.I have ulcers on both of my feet.I have had a foot ulcer for more than a year.I have had a chronic foot ulcer for at least 6 weeks.My ulcers are oozing pus or have a bad smell.I had surgery to fix a foot or leg problem within the last 8 weeks.I have had a deep vein thrombosis within the last 6 months.I haven't had immunosuppressants, radiation, or cell therapies in the last 60 days.I am HIV positive.My ulcer is between 1 cm and 4 cm in size.I agree to follow the study's rules, including shockwave treatments and wound care.I have signs of a skin infection near my ulcer.I have foot or leg problems that affect my wound healing.I have swelling due to lymph fluid buildup.I am older than 18 years.Your hemoglobin level is very low, below 7 g/dl for males or below 6.5 g/dl for females.My ABI is less than 0.6 and I need ulcer debridement under anesthesia soon.You are currently using drugs or alcohol excessively.I had surgery to improve blood flow in my legs within the last 8 weeks.My foot ulcer has reached the bone or joint.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 adverse effects might a patient experience if they undergo this treatment?
"This experimental therapy's safety rating is a 2 due to its status as Phase 2 trial, indicating that there are some clinical findings supporting this drug's security but not its efficacy."
Do I qualify for participation in this research project?
"This research requires 200 volunteers between the ages of eighteen and sixty-five with a current foot ulcer. To be eligible, they must additionally meet further prerequisites: Stage 1 superficial lesions through epidermis/dermis without penetrating to tendon, capsule or bone; diagnosis of single chronic plantar foot ulcer that has lasted at least 6 weeks; Type 2 diabetes mellitus (inquire if insulin dependent); capable of wound care independently; lesion dimensions greater than one centimetre but less than four centimetres in any dimension according to Lavery et al.; palpable pedal pulse in affected leg OR peripheral vascular disease evaluation showing acceptable blood"
Are there various locations where this experiment is occurring in the city?
"This medical trial is enrolling patients from Georgetown University Hospital in Washington, D.C., Calvary Hospital in Bronx, New york, Podiatry Group of South Texas in San Antonio, Texas and 5 additional sites."
Is the eligibility criteria for this research study open to individuals over twenty years of age?
"This research trial is for individuals between the ages of 18 and 65. There are 51 trials intended for minors under the age of 18 and 350 specifically designed to benefit elderly patients, aged over 65 years old."
Are there vacancies available for participants of this clinical experiment?
"The registry on clinicialtrials.gov has revealed that this research is not currently recruiting participants, despite having been first published on the 1st of March 2006 and updated most recently on 17th August 2006. However, there are 390 other active studies seeking out patients at present."
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What portion of applicants met pre-screening criteria?
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