Defocused Shock Wave Therapy for Chronic Wounds

Study Overview
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Brief Summary
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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.

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

Conditions
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Wounds

Intervention / Treatment
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* Device: Defocused shock wave therapy (DUOLITH® SD1)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline of the wound surface | 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 | 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 | Subjective wound-related pain was evaluated using the Visual Analogue Score | 15 days, 1 month and 3 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shock waves