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

Phase 1

Terminated

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

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.

Recruitment & Eligibility

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.

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group	Shockwave Therapy (SWT)	Participants will receive a combination of 5 weekly extracorporeal shockwave therapy sessions (SWT) and two sessions of autologous platelet-rich plasma (PRP) penile injection.
Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group	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.

Primary Outcome Measures

Name	Time	Method
Markers of Vasodilation	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	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	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)	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.

Secondary Outcome Measures

Name	Time	Method
Penile Blood Flow	Baseline	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.
EDITS Questionnaire Scores	Month 3 and Month 6	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.
Incidence of Serious Adverse Events (SAEs)	Baseline, up to 6 months	Incidence of Serious Adverse Events (SAEs), as assessed by study physician.