Defocused Shock Wave Therapy for Chronic Wounds

Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410447
• Other study ID #: 2
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2015
• Last updated: April 6, 2015
• Start date: May 2012
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds

Intervention

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

Locations

Country	Name	City	State
Italy	Sant'Andrea Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (17)

Arnó A, García O, Hernán 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Mittermayr R, Antonic V, Hartinger J, Kaufmann H, Redl H, Téot 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Schaden W, Thiele R, Kölpl 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. Epub 2007 Sep 27. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Changes from baseline of the wound characteristic	Wounds characteristics were assessed by the Bates-Jensen Wound Assessment Tool	15 days, 1 month and 3 months after treatment	Yes
Secondary	Improvement in subjective wound-related pain intensity	Subjective wound-related pain was evaluated using the Visual Analogue Score	15 days, 1 month and 3 months after treatment	Yes