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Completed

NCT Number: NCT02410447

Defocused Shock Wave Therapy for Chronic Wounds

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.

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Key information

Conditions

Wounds Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sant'Andrea Hospital

Rome, Italy, 00144

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Defocused shock wave therapy (DUOLITH® SD1)

Device

Primary outcomes

  1. Changes from baseline of the wound surface

    Time frame: 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 outcomes

  1. Changes from baseline of the wound characteristic

    Time frame: 15 days, 1 month and 3 months after treatment

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

  2. Improvement in subjective wound-related pain intensity

    Time frame: 15 days, 1 month and 3 months after treatment

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

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2015
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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