Defocused Shock Wave Therapy for Chronic Wounds

April 6, 2015 updated by: Mario Vetrano, MD, University of Roma La Sapienza

Defocused Shock Wave Therapy for Chronic Soft Tissue Wounds of the Lower Limbs. A Pilot Study

Chronic soft tissue wounds of the lower limbs are painful and debilitating condition that significantly reduce the quality of life of the patient. They often do not respond to conservative treatments or advanced wound managements. Focused and defocused extracorporeal shock wave therapy can be a viable alternative therapeutic strategy.

The purpose of the study was to examine the effects of defocused extracorporeal shock wave treatment on chronic soft tissue wounds of the lower limbs, in terms of the rate of wound healing and pain control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00144
        • Sant'Andrea Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic post-traumatic, venous, arterial, diabetic, or mixed wound of the lower limb
  • wound persisting for longer than three months
  • a wound surface bigger than 0,5 cm2
  • a wound diameter between 0.5 and 5 cm
  • unresponsiveness to conservative treatments and advanced wound managements in the 3 months prior to enrollment
  • no changes in wound managements during the study.

Exclusion Criteria:

  • an ankle brachial index (ABPI)<0.7 and TcPO2<40 mmHg
  • arrhythmias, presence of pacemaker, or coagulation disorders
  • use of anticoagulant drugs
  • neoplasia
  • pregnancy
  • soft tissue wound infections and/or osteomyelitis
  • patients with full-thickness loss of soft tissue and extension into muscle, bone, tendon, or joint capsule.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group

Defocused shock waves were provided by an electromagnetic generator (DUOLITH® SD1 - Storz Medical AG, Tägerwilen, Switzerland).

The protocol consisted of a series of 3 sessions in 2 weeks, 2 treatments a week. For each patient, a different number of impulses per session was delivered, depending on wound size (300 impulses + 100 impulses per cm2 wound-surface), at an energy flux density of 0.15 mJ/mm2 and a frequency of 5 pulses/s.
Device: Defocused shock wave therapy (DUOLITH® SD1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline of the wound surface
Time Frame: 15 days, 1 month and 3 months after treatment
Computerized digital photo documentation was used to define the size of the wound with a specific software
15 days, 1 month and 3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline of the wound characteristic
Time Frame: 15 days, 1 month and 3 months after treatment
Wounds characteristics were assessed by the Bates-Jensen Wound Assessment Tool
15 days, 1 month and 3 months after treatment
Improvement in subjective wound-related pain intensity
Time Frame: 15 days, 1 month and 3 months after treatment
Subjective wound-related pain was evaluated using the Visual Analogue Score
15 days, 1 month and 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 27, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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