Defocused Shock Wave Therapy for Chronic Wounds

University of Roma La Sapienza

Status and phase: Completed; Phase 3

Conditions: Wounds

Treatments: Device: Defocused shock wave therapy (DUOLITH® SD1)

Study type: Interventional

Funder types: Other

Identifiers

NCT02410447

2

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment Group

Experimental group

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.

Treatment:

Device: Defocused shock wave therapy (DUOLITH® SD1)