TerminatedPhase 1/2

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

Stopped: Funding ended

United States2 participantsStarted 2024-02-12

Plain-language 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.

Who can participate

Age range

30 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male
. Between 30 to 80 years of age (inclusive).
. Be able to provide written informed consent.
. Have a diagnosis of Mild to Moderate ED (12-21) or Mild ED (22-25) based on International Index of Erectile Dysfunction - Erectile Function (IIEF-EF) questionnaire score.
. Have diagnosis of Diabetes Mellitus (Type 1 or Type 2), as documented by history of Hemoglobin A1C \> 7% OR on medical therapy for Diabetes.
. Be in a stable relationship and have a minimum of 2 sexual attempts per month for at least one month prior to enrollment.
. Agree to comply with all study related tests/procedures.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Markers of Vasodilation

Timeframe: Baseline, Month 3, Month 6

Endothelial Function Markers

Timeframe: Baseline, Month 3, Month 6

Markers of Neo-angiogenesis

Timeframe: Baseline to Month 3, Baseline to Month 6

Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs)

Timeframe: Baseline, Month 3, Month 6

Trial details

NCT IDNCT05525572

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-02

Results submitted2024-11-21

View on ClinicalTrials.gov More Erectile Dysfunction With Diabetes Mellitus trials

Who can participate

Age range

30 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male
. Between 30 to 80 years of age (inclusive).
. Be able to provide written informed consent.
. Have a diagnosis of Mild to Moderate ED (12-21) or Mild ED (22-25) based on International Index of Erectile Dysfunction - Erectile Function (IIEF-EF) questionnaire score.
. Have diagnosis of Diabetes Mellitus (Type 1 or Type 2), as documented by history of Hemoglobin A1C \> 7% OR on medical therapy for Diabetes.
. Be in a stable relationship and have a minimum of 2 sexual attempts per month for at least one month prior to enrollment.
. Agree to comply with all study related tests/procedures.

What they're measuring

Markers of Vasodilation

Timeframe: Baseline, Month 3, Month 6

Endothelial Function Markers

Timeframe: Baseline, Month 3, Month 6

Markers of Neo-angiogenesis

Timeframe: Baseline to Month 3, Baseline to Month 6

Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs)

Timeframe: Baseline, Month 3, Month 6

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria