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Platelet-Rich Plasma Therapy
Shockwave Therapy + PRP for Erectile Dysfunction (COCKTAIL-DM Trial)
Phase 1 & 2
Waitlist Available
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
No Placebo-Only Group
Summary
This trial is testing a new treatment combining sound waves and special blood components to help diabetic men with erectile dysfunction. The sound waves aim to improve blood flow, while the blood components help repair damaged tissues. The goal is to see if this combination can better restore erectile function compared to other treatments.
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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs)
Changes in endothelial function markers
Changes in markers of neo-angiogenesis
+1 moreSecondary study objectives
Change in Penile Blood Flow
EDITS questionnaire scores
Incidence of Serious Adverse Events (SAEs)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) are emerging treatments for Erectile Dysfunction (ED) that focus on improving vascular and tissue health. SWT uses mechanical pulses to stimulate angiogenesis, enhancing blood flow to the penile tissue, which is vital for achieving and maintaining erections.
PRP involves injecting concentrated platelets from the patient's own blood into the penile tissue, releasing growth factors that promote tissue repair and regeneration. These treatments are significant for ED patients as they target the root causes of ED, potentially offering more sustainable and long-term benefits compared to conventional therapies that mainly provide temporary symptom relief.
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Who is running the clinical trial?
University of MiamiLead Sponsor
944 Previous Clinical Trials
427,379 Total Patients Enrolled
6 Trials studying Erectile Dysfunction
487 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
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