Clinical trial NCT05525572: Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM)
Official title: Combining Shockwave Therapy and Platelet Rich Plasma to Treat Erectile Dysfunction in Diabetic Men (COCKTAIL-DM)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Erectile Dysfunction With Diabetes Mellitus
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 2
Sex: MALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male
2. Between 30 to 80 years of age (inclusive).
3. Be able to provide written informed consent.
4. 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.
5. Have diagnosis of Diabetes Mellitus (Type 1 or Type 2), as documented by history of Hemoglobin A1C \> 7% OR on medical therapy for Diabetes.
6. Be in a stable relationship and have a minimum of 2 sexual attempts per month for at least one month prior to enrollment.
7. Agree to comply with all study related tests/procedures.

Exclusion Criteria:

1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
2. Previous history of priapism, penile fracture, Peyronie's Disease, or penile curvature that negatively influences sexual activity.
3. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%).
4. Psychogenic ED as determined by study investigator.
5. Patients using Intracavernous Injections (ICI) for management of ED.
6. Patients with generalized polyneuropathy, neurological conditions, or psychiatric disease (such as bipolar disorder or depression).
7. 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.
8. History of consistent treatment failure with Phosphodiesterase 5 (PDE5) inhibitors for therapy of ED.
9. Poorly controlled diabetes as indicated by Hemoglobin a1c \> 7.5%.
10. Use of antiplatelet medications

Primary outcomes:
measure: Markers of Vasodilation
timeFrame: Baseline, Month 3, Month 6
measure: Endothelial Function Markers
timeFrame: Baseline, Month 3, Month 6
measure: Markers of Neo-angiogenesis
timeFrame: Baseline to Month 3, Baseline to Month 6
measure: Endothelial Progenitor Cell Colony Forming Units (EPC-CFUs)
timeFrame: Baseline, Month 3, Month 6
Secondary outcomes:
measure: Penile Blood Flow
timeFrame: Baseline
measure: EDITS Questionnaire Scores
timeFrame: Month 3 and Month 6
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Baseline, up to 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami, School of Medicine - Desai Sethi Urology Institute
state: Florida
Study officials:
affiliation: University of Miami
name: Thomas A Masterson, MD
role: PRINCIPAL_INVESTIGATOR
References: