Wounds
Conditions
Keywords
Shock waves
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.
Interventions
DEVICEDefocused shock wave therapy (DUOLITH® SD1)
Sponsors
University of Roma La Sapienza
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline of the wound surface | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline of the wound characteristic | 15 days, 1 month and 3 months after treatment | Wounds characteristics were assessed by the Bates-Jensen Wound Assessment Tool |
| Improvement in subjective wound-related pain intensity | 15 days, 1 month and 3 months after treatment | Subjective wound-related pain was evaluated using the Visual Analogue Score |
Countries
Italy
Outcome results
None listed