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The Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and DFUs

NCT03640988 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-11-08

No results posted yet for this study

Summary

This is an observational, single-arm, on-label study. This clinical study will be conducted at up to 2 sites with a total of 10 subjects per site. All subjects will receive standard of care treatment which includes DFU treatments with the dermaPACE device.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

dermaPACE

Shockwave application

Sponsors & Collaborators

  • SANUWAVE, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Granick, MD FACS · University Hospital/Rutgers University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-25
Primary Completion
2021-01-03
Completion
2021-01-03
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03640988 on ClinicalTrials.gov