Clinical trial NCT02410447: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wounds
Keywords: Shock waves
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes from baseline of the wound surface
timeFrame: 15 days, 1 month and 3 months after treatment
Secondary outcomes:
measure: Changes from baseline of the wound characteristic
timeFrame: 15 days, 1 month and 3 months after treatment
measure: Improvement in subjective wound-related pain intensity
timeFrame: 15 days, 1 month and 3 months after treatment
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sant'Andrea Hospital
Study officials:
References:
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