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Platelet-Rich Plasma Therapy
Shockwave Therapy + PRP for Erectile Dysfunction (COCKTAIL-DM Trial)
Phase 1 & 2
Recruiting
Led By Thomas A Masterson, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 3 and at month 6
Awards & highlights
COCKTAIL-DM Trial Summary
This trial is testing whether a combination of two treatments, Shockwave Therapy and Platelet Rich Plasma, can improve erectile dysfunction in diabetic patients.
Who is the study for?
Men aged 30-80 with mild to moderate erectile dysfunction and diabetes (Type 1 or Type 2) are eligible for this trial. They must have a stable sexual relationship, making at least two attempts per month, and be willing to follow study procedures. Men with poorly controlled diabetes, previous penile surgery other than circumcision, abnormal testosterone levels, serious illnesses that affect study participation or safety, psychogenic ED, certain neurological conditions or psychiatric diseases are excluded.Check my eligibility
What is being tested?
The COCKTAIL-DM trial is testing if Shockwave Therapy combined with Platelet Rich Plasma can improve erectile function in diabetic men by repairing microvascular issues caused by Erectile Dysfunction. Participants will receive both treatments and their effects on improving erections will be assessed.See study design
What are the potential side effects?
Potential side effects may include pain at the injection site from PRP therapy, bruising, swelling, infection risk increase due to injections involved in PRP therapy; SWT might cause skin redness or soreness.
COCKTAIL-DM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at month 3 and at month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 3 and at month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs)
Changes in endothelial function markers
Changes in markers of neo-angiogenesis
+1 moreSecondary outcome measures
Change in Penile Blood Flow
EDITS questionnaire scores
Incidence of Serious Adverse Events (SAEs)
COCKTAIL-DM Trial Design
1Treatment groups
Experimental Treatment
Group I: Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) GroupExperimental Treatment2 Interventions
Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection.
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Who is running the clinical trial?
University of MiamiLead Sponsor
902 Previous Clinical Trials
410,001 Total Patients Enrolled
6 Trials studying Erectile Dysfunction
586 Patients Enrolled for Erectile Dysfunction
Thomas A Masterson, MDPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 30 and 80 years old.I am in a stable relationship and have had sex at least twice a month for the last month.I am male.I use injections for erectile dysfunction treatment.I am between 30 and 80 years old.I have a condition like generalized polyneuropathy, a neurological issue, or a psychiatric disease.I have tried ED medications without success.I have mild to moderate erectile dysfunction.I have diabetes with an A1C over 7% or I am on medication for it.I am taking medication to prevent blood clots.I have had penile surgery, excluding circumcision and condyloma removal.I have diabetes with an A1C over 7% or am on medication for it.I have mild to moderate erectile dysfunction according to the IIEF-EF score.I have had conditions affecting my penis that make sex difficult.You agree to comply with all study related tests/procedures.I am in a stable relationship and have been sexually active at least twice a month for the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Erectile Dysfunction Patient Testimony for trial: Trial Name: NCT05525572 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If a person is over the age of 20, can they participate in this experiment?
"The age range for participants in this clinical trial is between 30 and 80 years old."
Answered by AI
Is enrollment still available for this clinical trial?
"That is correct. The clinicaltrials.gov website indicates that this study, which was originally posted on November 1st 2022, is presently looking for 15 research participants from a single location."
Answered by AI
How many people fit the qualifications for this test?
"Indeed, the listing on clinicaltrials.gov currently says that this research is seeking participants. The trial was first advertised on November 1st, 2022 and has had one update since then, on September 27th, 2022. They aim to enroll 15 people total at a single site."
Answered by AI
Who would be most likely to benefit from participating in this clinical trial?
"This study is looking for 15 participants that have diabetes mellitus and are aged between 30 and 80. Candidates must meet the following criteria: Male, Between 30 to 80 years of age (inclusive), Have a diagnosis of Mild to Moderate ED based on International Index of Erectile dysfunction - Erectile Function (IIEF-EF) questionnaire, Have diagnosis of Diabetes Mellitus (Type 1 or Type 2), as documented by history of Hemoglobin A1C > 7% OR on medical therapy for Diabetes., In a stable heterosexual relationship and have a minimum of 2 sexual attempts per month for at least one month prior"
Answered by AI
Who else is applying?
What state do they live in?
Hawaii
Georgia
Florida
What site did they apply to?
University of Miami, School of Medicine - Desai Sethi Urology Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I have tried viagara cilais with little effect. Try to avoid a prosthetic surgery if doesn’t work pills and injections really don’t work.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How lo g so screenings take?
PatientReceived 2+ prior treatments
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