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Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers

NCT00536744 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2014-04-14

Study results available
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Summary

The purpose of this study is to compare the safety and effectiveness of the dermaPACE Device to sham application, when administered in conjunction with standard treatments used in the treatment of DFUs.

Conditions

  • Diabetic Foot Ulcers

Interventions

DEVICE

acoustical pulse energy (extracorporeal shockwave)

Acoustical pulse energy (extracorporeal shockwave) + Standard of care wound dressing.

OTHER

Sham

Non-energized (inactive - Sham) application + standard of care

Sponsors & Collaborators

  • SANUWAVE, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Jorgensen, MD · SANUWAVE, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-06-30
Completion
2010-09-30

Countries

  • United States
  • Germany
  • United Kingdom

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 NCT00536744 on ClinicalTrials.gov