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Defocused Shock Wave Therapy for Chronic Wounds

Primary Purpose

Wounds

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Defocused shock wave therapy (DUOLITH® SD1)

About this trial

This is an interventional treatment trial for Wounds focused on measuring Shock waves

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sant'Andrea Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes from baseline of the wound surface

Computerized digital photo documentation was used to define the size of the wound with a specific software

Secondary Outcome Measures

Changes from baseline of the wound characteristic

Wounds characteristics were assessed by the Bates-Jensen Wound Assessment Tool

Improvement in subjective wound-related pain intensity

Subjective wound-related pain was evaluated using the Visual Analogue Score

Full Information

NCT ID

NCT02410447

First Posted

March 27, 2015

Last Updated

April 6, 2015

Sponsor

University of Roma La Sapienza

1. Study Identification

Unique Protocol Identification Number

NCT02410447

Brief Title

Defocused Shock Wave Therapy for Chronic Wounds

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Roma La Sapienza

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wounds

Keywords

Shock waves

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Defocused shock wave therapy (DUOLITH® SD1)

Primary Outcome Measure Information:

Title

Changes from baseline of the wound surface

Description

Computerized digital photo documentation was used to define the size of the wound with a specific software

Time Frame

15 days, 1 month and 3 months after treatment

Secondary Outcome Measure Information:

Title

Changes from baseline of the wound characteristic

Description

Wounds characteristics were assessed by the Bates-Jensen Wound Assessment Tool

Time Frame

15 days, 1 month and 3 months after treatment

Title

Improvement in subjective wound-related pain intensity

Description

Subjective wound-related pain was evaluated using the Visual Analogue Score

Time Frame

15 days, 1 month and 3 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Sant'Andrea Hospital

City

Rome

ZIP/Postal Code

00144

Country

Italy

12. IPD Sharing Statement

Citations:

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17904157

Citation

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Defocused Shock Wave Therapy for Chronic Wounds

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