NCT05525572

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: Male
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction With Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	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.
DRUG	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.

Timeline

• Start date: 2024-02-12
• Primary completion: 2024-08-02
• Completion: 2024-08-02
• First posted: 2022-09-01
• Last updated: 2025-02-28
• Results posted: 2025-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study