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

NCT05525572 | Terminated Phase 1 Results DMC FDA Drug FDA Device

• 1 other identifier: 20220540
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, Month 3, Month 6

Secondary Outcomes (3)

• Penile Blood Flow

  Baseline

• EDITS Questionnaire Scores

  Month 3 and Month 6

• Incidence of Serious Adverse Events (SAEs)

  Baseline, up to 6 months

Study Arms (1)

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.

Device: Shockwave Therapy (SWT); Drug: Autologous Platelet-Rich Plasma (PRP)

Interventions

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.

Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group

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.

Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami, School of Medicine - Desai Sethi Urology Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Thomas A Masterson, III
• Organization: University of Miami, Miller School of Medicine

TMasterson@med.miami.edu

(305) 243 - 6260

Study Officials

• Thomas A Masterson, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: September 1, 2022
• Study Start: February 12, 2024
• Primary Completion: August 2, 2024
• Study Completion: August 2, 2024
• Last Updated: February 28, 2025
• Results First Posted: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)