Erectile Dysfunction With Diabetes MellitusPhase 1/2COCKTAIL-DMNCT05525572
Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM)
A Phase 1/2 study testing Shockwave Therapy (SWT) and Autologous Platelet-Rich Plasma (PRP) in people with Erectile Dysfunction With Diabetes Mellitus, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction With Diabetes Mellitus
- What is being tested?
- Shockwave Therapy (SWT) and Autologous Platelet-Rich Plasma (PRP)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to 2 Aug 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
- Previous history of priapism, penile fracture, Peyronie's Disease, or penile curvature that negatively influences sexual activity.
- Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%).
- Psychogenic ED as determined by study investigator.
- Patients using Intracavernous Injections (ICI) for management of ED.
- Patients with generalized polyneuropathy, neurological conditions, or psychiatric disease (such as bipolar disorder or depression).
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- Have a serious comorbid illness or condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
- History of consistent treatment failure with Phosphodiesterase 5 (PDE5) inhibitors for therapy of ED.
- Poorly controlled diabetes as indicated by Hemoglobin a1c > 7.5%.
- Use of antiplatelet medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami, School of Medicine - Desai Sethi Urology Institute
Miami, Florida, 33136
About this study
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.
- Being tested
- Shockwave Therapy (SWT), Autologous Platelet-Rich Plasma (PRP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave Therapy (SWT)Device
Shockwave Therapy (SWT):
720 shocks will be administered administered in every session to each treated region (left and right corpora cavernosa and crura). Each session will last approximately 20 minutes. A total of 3600 shocks will be administered over 5 weekly sessions.
Autologous Platelet-Rich Plasma (PRP)Drug
Autologous Platelet Rich Plasma (PRP):
5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval.
| Study group | Role | What they receive |
|---|---|---|
| Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group | Experimental | Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection. Receives: Device: Shockwave Therapy (SWT); Drug: Autologous Platelet-Rich Plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of Vasodilation
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.
Measured: Baseline, Month 3, Month 6
Endothelial Function Markers
Markers of endothelial function will include Vascular Endothelial Growth Factor (VEGF), Stromal cell-derived factor 1 (SDF-1α), and Stem Cell Factor (SCF). All measured from serum blood samples in units of pg/mL.
Measured: Baseline, Month 3, Month 6
Markers of Neo-angiogenesis
Markers of neo-angiogenesis reported as the percentage of Cluster of Differentiation 31 positive cells (CD31+), as measured from serum blood samples and expressed as a percentage.
Measured: Baseline to Month 3, Baseline to Month 6
Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs)
Endothelial Progenitor Cell (EPC) Colony Forming Units (CFUs) as measured from peripheral blood samples in units of average cells per well.
Measured: Baseline, Month 3, Month 6
Secondary outcomes (3)
Penile Blood Flow
Penile Blood Flow will be reported as Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV), both assessed in cm/sec, via Penile Doppler ultrasonography.
Measured: Baseline
EDITS Questionnaire Scores
Treatment satisfaction is assessed by the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. EDITS questionnaire is an 11-item tool addressing participant satisfaction with ED therapy. Each item is a 5-point Likert-type scale from 0 "no satisfaction or dissatisfaction" to 4 "high satisfaction." Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.
Measured: Month 3 and Month 6
Incidence of Serious Adverse Events (SAEs)
Incidence of Serious Adverse Events (SAEs), as assessed by study physician.
Measured: Baseline, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start12 Feb 2024
- Primary completion2 Aug 2024
- Study completion2 Aug 2024
Why it stopped: Funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erectile Dysfunction With Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Masterson, University of Miami
- Investigators
- Thomas A Masterson, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525572
- Sponsor's protocol ID
- 20220540
- Acronym
- COCKTAIL-DM
- Status last verified
- Feb 2025
- First submitted
- 13 Apr 2022
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM)
- ClinicalTrials.gov ID
- NCT05525572
- Acronym / sponsor ID
- COCKTAIL-DM / 20220540
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Posted 28 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group | Experimental | Device: Shockwave Therapy (SWT), Drug: Autologous Platelet-Rich Plasma (PRP)Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
- Previous history of priapism, penile fracture, Peyronie's Disease, or penile curvature that negatively influences sexual activity.
- Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%).
- Psychogenic ED as determined by study investigator.
- Patients using Intracavernous Injections (ICI) for management of ED.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shockwave Therapy (SWT)Shockwave Therapy (SWT): 720 shocks will be administered administered in every session to each treated region (left and right corpora cavernosa and crura). Each session will last approximately 20 minutes. A total of 3600 shocks will be administered over 5 weekly sessions. | Device | Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group |
| Autologous Platelet-Rich Plasma (PRP)Autologous Platelet Rich Plasma (PRP): 5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval. | Drug | Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group |
Primary outcome
Markers of Vasodilation
Time frame: Baseline, Month 3, Month 6
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.
Endothelial Function Markers
Time frame: Baseline, Month 3, Month 6
Markers of endothelial function will include Vascular Endothelial Growth Factor (VEGF), Stromal cell-derived factor 1 (SDF-1α), and Stem Cell Factor (SCF). All measured from serum blood samples in units of pg/mL.
Markers of Neo-angiogenesis
Time frame: Baseline to Month 3, Baseline to Month 6
Markers of neo-angiogenesis reported as the percentage of Cluster of Differentiation 31 positive cells (CD31+), as measured from serum blood samples and expressed as a percentage.
Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs)
Time frame: Baseline, Month 3, Month 6
Endothelial Progenitor Cell (EPC) Colony Forming Units (CFUs) as measured from peripheral blood samples in units of average cells per well.
3 secondary outcomes
Penile Blood Flow
Time frame: Baseline
EDITS Questionnaire Scores
Time frame: Month 3 and Month 6
Incidence of Serious Adverse Events (SAEs)
Time frame: Baseline, up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas A Masterson, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Shockwave Therapy (SWT) and Autologous Platelet-Rich Plasma (PRP) in people with Erectile Dysfunction With Diabetes Mellitus, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markers of Vasodilation (time frame: Baseline, Month 3, Month 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.