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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 weeks
Treatment ~ Varies
Follow Up ~at month 3 and at month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 3 and at month 6 for reporting.

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 more
Secondary 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.

Find a Location

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

Autologous Platelet-Rich Plasma (PRP) (Platelet-Rich Plasma Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05525572 — Phase 1 & 2
Erectile Dysfunction Research Study Groups: Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group
Erectile Dysfunction Clinical Trial 2023: Autologous Platelet-Rich Plasma (PRP) Highlights & Side Effects. Trial Name: NCT05525572 — Phase 1 & 2
Autologous Platelet-Rich Plasma (PRP) (Platelet-Rich Plasma Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05525572 — Phase 1 & 2
Erectile Dysfunction Patient Testimony for trial: Trial Name: NCT05525572 — Phase 1 & 2
~1 spots leftby Oct 2025