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NCT05525572 · ClinicalTrials.gov registry record · Phase 1

Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM)

A Phase 1 study, sponsored by University of Miami.

Terminated
Registry status
Phase 1
Development phase
2
Enrollment target

NCT05525572: Clinical Trial Phase 1 study, sponsored by University of Miami.

NCT05525572 is a Phase 1 study that was terminated before completion, run by University of Miami. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05525572, a Phase 1 study, was terminated before completion, sponsored by University of Miami.

TERMINATED
Registry status
Phase 1
Development phase
2 participants
Enrollment target

Study Summary

The purpose of this research study is to evaluate whether the combination of Shockwave Therapy (SWT) with Platelet Rich Plasma (PRP) is synergistic and can reverse the pathology of microvascular Erectile Dysfunction (ED) and enhance erectile function in diabetics patients.

Primary Outcome

Markers of vasodilation including Endothelial Nitric Oxide Synthase (eNOS) and Neuronal Nitric Oxide Synthase (nNOS) will be measured from serum blood samples in units of ug/mL.

Interventions

  • DEVICE Shockwave Therapy (SWT)
  • DRUG Autologous Platelet-Rich Plasma (PRP)

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2024-02-12
Est. Completion 2024-08-02
Phase Phase 1
University of Miami

721 total trials

Why NCT05525572 stopped before completion

NCT05525572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Shockwave Therapy (SWT) is the first listed.

NCT05525572 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05525572 about?

NCT05525572 is a clinical study titled "Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM)". The purpose of this research study is to evaluate whether the combination of Shockwave Therapy (SWT) with Platelet Rich Plasma (PRP) is synergistic and can reverse the pathology of microvascular Erectile Dysfunction (ED) and enhance erectile function in diabetics patients.

What is the current status of trial NCT05525572?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2024-02-12. Estimated completion is 2024-08-02.

What interventions are being tested in trial NCT05525572?

The interventions under investigation include: Shockwave Therapy (SWT) (DEVICE), Autologous Platelet-Rich Plasma (PRP) (DRUG).

Who is sponsoring clinical trial NCT05525572?

This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05525572's enrollment target sits among peer trials

2 2000th of 2000 the lowest of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05525572, the US trial registry maintained by the National Library of Medicine. NCT05525572 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.