Shockwave Therapy (SWT) for Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, School of Medicine - Desai Sethi Urology Institute, Miami, FL
Diabetes Mellitus+1 More
Shockwave Therapy (SWT) - Device
Eligibility
18+
Male
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 3 Secondary · Reporting Duration: At Month 3 and At Month 6

Month 6
EDITS questionnaire scores
Month 6
Changes in EPC-CFUs
Changes in endothelial function markers
Changes in markers of neo-angiogenesis
Changes in markers of vasodilation
Baseline to Month 6
Change in Penile Blood Flow
Up to Month 6
Incidence of Serious Adverse Events (SAEs)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) Group
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Shockwave Therapy (SWT) · No Placebo Group · Phase 1 & 2

Shockwave Therapy (SWT) + Platelet-Rich Plasma (PRP) GroupExperimental Group · 2 Interventions: Autologous Platelet-Rich Plasma (PRP), Shockwave Therapy (SWT) · Intervention Types: Drug, Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at month 3 and at month 6
Closest Location: University of Miami, School of Medicine - Desai Sethi Urology Institute · Miami, FL
Photo of Miami 1Photo of Miami 2Photo of Miami 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Diabetes Mellitus
0 CompletedClinical Trials

Who is running the clinical trial?

University of MiamiLead Sponsor
780 Previous Clinical Trials
381,747 Total Patients Enrolled
12 Trials studying Diabetes Mellitus
3,478 Patients Enrolled for Diabetes Mellitus
Thomas A Masterson, MDPrincipal InvestigatorUniversity of Miami

Eligibility Criteria

Age 18+ · Male Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have Diabetes Mellitus (Type 1 or Type 2).
You agree to comply with all study related tests/procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.