A Phase 1/2 interventional study of Shockwave Therapy (SWT) and Autologous Platelet-Rich Plasma (PRP) in Erectile Dysfunction With Diabetes Mellitus, sponsored by University of Miami. Terminated at 1 site in United States. Open to male participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by University of Miami · Phase 1/2, Interventional, and Treatment
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.
683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.
This study's enrollment of 2 is below the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection.
Device: Shockwave Therapy (SWT) · Drug: Autologous Platelet-Rich Plasma (PRP)
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): 5 mL PRP will be administered via intra-cavernous penile injection with a 30 ± 7 day treatment interval.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Month 3, Month 6
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.
Time frame: 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.
Time frame: Month 3 and Month 6
Incidence of Serious Adverse Events (SAEs)
Incidence of Serious Adverse Events (SAEs), as assessed by study physician.
Time frame: Baseline, up to 6 months
| Milestone | Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group |
|---|---|
| Started | 2 |
| Completed | 0 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 2 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Endothelial Progenitor Cell (EPC) Colony Forming Units (CFUs) as measured from peripheral blood samples in units of average cells per well.
No measurements were reported for this outcome.
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.
| cm/sec | Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group |
|---|---|
| Right Peak Systolic Velocity (PSV) | 39.1 |
| Right End Diastolic Velocity (EDV) | 0.0 |
| Left Peak Systolic Velocity (PSV) | 35.4 |
| Left End Diastolic Velocity (EDV) | 4.2 |
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.
No measurements were reported for this outcome.
Incidence of Serious Adverse Events (SAEs), as assessed by study physician.
| events | Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group |
|---|---|
| Incidence of Serious Adverse Events (SAEs) | 0 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Continuous(years) | Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group |
|---|---|
| Mean | 57 ± 17 |
| Sex: Female, Male(Participants) | Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group |
|---|---|
| Female | 0 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 1 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
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