NCT02410447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

March 27, 2015

Last Update Submit

April 6, 2015

Conditions

Wounds

Keywords

Shock waves

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Changes from baseline of the wound characteristic

    15 days, 1 month and 3 months after treatment

  • Improvement in subjective wound-related pain intensity

    15 days, 1 month and 3 months after treatment

Study Arms (1)

Treatment Group

EXPERIMENTAL

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)

Interventions

Defocused shock wave therapy (DUOLITH® SD1)DEVICE
Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sant'Andrea Hospital

Rome, Italy, 00144, Italy

Location

Related Publications (17)

  • Schaden W, Thiele R, Kolpl C, Pusch M, Nissan A, Attinger CE, Maniscalco-Theberge ME, Peoples GE, Elster EA, Stojadinovic A. Shock wave therapy for acute and chronic soft tissue wounds: a feasibility study. J Surg Res. 2007 Nov;143(1):1-12. doi: 10.1016/j.jss.2007.01.009. Epub 2007 Sep 27.

    PMID: 17904157BACKGROUND

  • Saggini R, Figus A, Troccola A, Cocco V, Saggini A, Scuderi N. Extracorporeal shock wave therapy for management of chronic ulcers in the lower extremities. Ultrasound Med Biol. 2008 Aug;34(8):1261-71. doi: 10.1016/j.ultrasmedbio.2008.01.010. Epub 2008 Apr 18.

    PMID: 18394777BACKGROUND

  • Moretti B, Notarnicola A, Maggio G, Moretti L, Pascone M, Tafuri S, Patella V. The management of neuropathic ulcers of the foot in diabetes by shock wave therapy. BMC Musculoskelet Disord. 2009 May 27;10:54. doi: 10.1186/1471-2474-10-54.

    PMID: 19473538BACKGROUND

  • Arno A, Garcia O, Hernan I, Sancho J, Acosta A, Barret JP. Extracorporeal shock waves, a new non-surgical method to treat severe burns. Burns. 2010 Sep;36(6):844-9. doi: 10.1016/j.burns.2009.11.012. Epub 2010 Jan 13.

    PMID: 20071091BACKGROUND

  • Mittermayr R, Antonic V, Hartinger J, Kaufmann H, Redl H, Teot L, Stojadinovic A, Schaden W. Extracorporeal shock wave therapy (ESWT) for wound healing: technology, mechanisms, and clinical efficacy. Wound Repair Regen. 2012 Jul-Aug;20(4):456-65. doi: 10.1111/j.1524-475X.2012.00796.x. Epub 2012 May 29.

    PMID: 22642362BACKGROUND

  • Haupt G, Chvapil M. Effect of shock waves on the healing of partial-thickness wounds in piglets. J Surg Res. 1990 Jul;49(1):45-8. doi: 10.1016/0022-4804(90)90109-f.

    PMID: 2359293BACKGROUND

  • Kuo YR, Wang CT, Wang FS, Yang KD, Chiang YC, Wang CJ. Extracorporeal shock wave treatment modulates skin fibroblast recruitment and leukocyte infiltration for enhancing extended skin-flap survival. Wound Repair Regen. 2009 Jan-Feb;17(1):80-7. doi: 10.1111/j.1524-475X.2008.00444.x.

    PMID: 19152654BACKGROUND

  • Wang CJ, Wu RW, Yang YJ. Treatment of diabetic foot ulcers: a comparative study of extracorporeal shockwave therapy and hyperbaric oxygen therapy. Diabetes Res Clin Pract. 2011 May;92(2):187-93. doi: 10.1016/j.diabres.2011.01.019. Epub 2011 Apr 6.

    PMID: 21310502BACKGROUND

  • Mariotto S, Cavalieri E, Amelio E, Ciampa AR, de Prati AC, Marlinghaus E, Russo S, Suzuki H. Extracorporeal shock waves: from lithotripsy to anti-inflammatory action by NO production. Nitric Oxide. 2005 Mar;12(2):89-96. doi: 10.1016/j.niox.2004.12.005.

    PMID: 15740982BACKGROUND

  • Ohtori S, Inoue G, Mannoji C, Saisu T, Takahashi K, Mitsuhashi S, Wada Y, Takahashi K, Yamagata M, Moriya H. Shock wave application to rat skin induces degeneration and reinnervation of sensory nerve fibres. Neurosci Lett. 2001 Nov 23;315(1-2):57-60. doi: 10.1016/s0304-3940(01)02320-5.

    PMID: 11711214BACKGROUND

  • Kuo YR, Wang CT, Wang FS, Chiang YC, Wang CJ. Extracorporeal shock-wave therapy enhanced wound healing via increasing topical blood perfusion and tissue regeneration in a rat model of STZ-induced diabetes. Wound Repair Regen. 2009 Jul-Aug;17(4):522-30. doi: 10.1111/j.1524-475X.2009.00504.x.

    PMID: 19614917BACKGROUND

  • Hayashi D, Kawakami K, Ito K, Ishii K, Tanno H, Imai Y, Kanno E, Maruyama R, Shimokawa H, Tachi M. Low-energy extracorporeal shock wave therapy enhances skin wound healing in diabetic mice: a critical role of endothelial nitric oxide synthase. Wound Repair Regen. 2012 Nov-Dec;20(6):887-95. doi: 10.1111/j.1524-475X.2012.00851.x. Epub 2012 Oct 30.

    PMID: 23110611BACKGROUND

  • Larking AM, Duport S, Clinton M, Hardy M, Andrews K. Randomized control of extracorporeal shock wave therapy versus placebo for chronic decubitus ulceration. Clin Rehabil. 2010 Mar;24(3):222-9. doi: 10.1177/0269215509346083. Epub 2010 Feb 15.

    PMID: 20156981BACKGROUND

  • Stieger M, Schmid JP, Bajrami S, Hunziker T. [Extracorporeal shock wave therapy as a treatment of a non-healing chronic leg ulcer]. Hautarzt. 2013 Jun;64(6):443-6. doi: 10.1007/s00105-012-2527-4. German.

    PMID: 23322179BACKGROUND

  • Omar MT, Alghadir A, Al-Wahhabi KK, Al-Askar AB. Efficacy of shock wave therapy on chronic diabetic foot ulcer: a single-blinded randomized controlled clinical trial. Diabetes Res Clin Pract. 2014 Dec;106(3):548-54. doi: 10.1016/j.diabres.2014.09.024. Epub 2014 Oct 5.

    PMID: 25451894BACKGROUND

  • Wolff KS, Wibmer A, Pusch M, Prusa AM, Pretterklieber M, Teufelsbauer H, Schaden W. The influence of comorbidities and etiologies on the success of extracorporeal shock wave therapy for chronic soft tissue wounds: midterm results. Ultrasound Med Biol. 2011 Jul;37(7):1111-9. doi: 10.1016/j.ultrasmedbio.2011.04.007. Epub 2011 Jun 2.

    PMID: 21640475BACKGROUND

  • Wang CJ, Kuo YR, Wu RW, Liu RT, Hsu CS, Wang FS, Yang KD. Extracorporeal shockwave treatment for chronic diabetic foot ulcers. J Surg Res. 2009 Mar;152(1):96-103. doi: 10.1016/j.jss.2008.01.026. Epub 2008 Mar 7.

    PMID: 18619622BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 27, 2015

First Posted

April 7, 2015

Study Start

May 1, 2012

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

IT(1)