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

Diabetic Foot Ulcer Clinical Trial

Official title:
A Post-market Pilot Study to Evaluate the Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and Healing of Diabetic Foot Ulcers

Clinical Trial 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.

Clinical Trial Description

The dermaPACE system will be used according to label along with standard of care. perfusion will be measured using TcPO2 methods and also using cleared hyperspectral imaging equipment. The intent of the study is to observe/measure oxygen saturation levels in the area of the treated wound before initiation of dermaPACE treatment, during the treatment period, and two weeks post treatment period ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03640988
Study type Interventional
Source SANUWAVE, Inc.
Contact
Status Terminated
Phase N/A
Start date April 25, 2019
Completion date January 3, 2021
View Details
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