Shockwave Therapy in Patients With Chronic Wounds

NCT06210399 | Completed

• 1 other identifier: 10
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Chronic wounds are a major health problem with impact in the quality of life of patients, increased their morbidity and mortality, nursing burden, extend the hospital stays, and healthcare costs. Searching how to apply the best care available in wounds, shock wave treatment is found in order to stimulate tissue growth in this type of skin injuries. There are different studies to support this recommendation but also there is variability about of patients, different types of injuries or settings. It is considered that more research studies are needed to maintain this evidence and to explore other settings like the effectiveness in a medium stay hospital. Objectives: To assess the effectiveness of shockwave treatment to reduce the size of chronic wounds. Method: A quasi-experimental design will be used. The population under study will include patients admitted in the Functional Recovery Unit who present chronic wounds upon admission. The sample size will be 30 patients. An intentional non-probabilistic sampling will be carried out. Main outcome: decrease the wound size. Sociodemographic variables, personal history, comorbidities, current clinical situation, shock wave treatment variables and its evolution will be collected. Applicability: In case of findings are better than habitually care, the number of treatments required by the patient would be reduced, the patient's state of health would improve, the risk of infection of the wound decrease, and the comfort and quality of life of patients could improve. The findings may represent a change in clinical practice because they may be used to modify the treatment protocols for chronic wounds at the Guadarrama Hospital and in other similar hospitals. Also, they can contribute to the evidence based care which supports shockwave treatment.

Conditions

Wound Heal

Keywords

Extracorporeal Shockwave Therapy; Wound healing

Outcome Measures

Primary Outcomes (1)

• Decrease wound size area

  Decrease de size area at the end of the intervention. The surface of the wound will be measured in centimeters (length x width)

  All wounds will be measured at the end of the intervention (3 weeks).

Secondary Outcomes (4)

• To quantify the change in the size of chronic wounds treated with shock waves

  at the end of the intervention (3 weeks)

• To identify the patients variables related to achieve a lesion reduction equal to or greater than 50% of the surface measured in centimeters (greater success in healing).

  at the end of the intervention (3 weeks)

• To assess number and types of side effects what patients shows related to the use of low-frequency shockwaves in chronic wounds.

  at the end of the intervention (3 weeks)

• To assess whether the pain perception due to chronic wounds in patients undergoing the intervention decreases. The pain perception will be measured with Visual Analogue Scale (VAS) or Pain Assesment in Advanced Dementia Scale (PAINAD).

  Baseline and during the intervention (up 3 weeks)

Study Arms (1)

Extracorporeal Shockwave Therapy

EXPERIMENTAL

The parameters for shock wave therapy will be: frequency 4-6 Hz, intensity 0.075-0.11 mJ/mm2 (millijoules per millimeter), number of pulses 350+10xcm2 (square centimetre) of wound surface (the number of pulsations is dependent of the surface), with sterile field (sterile gel on the wound and sterile transparent film to cover it). They will be applied by sweeping the surface of the wound and 1 centimetre around it. In each session, the session-specific data notebook and the appearance of side effects (pain, bleeding, others) will be recorded. Subsequently, the conventional healing procedure will be applied, according to the procedures for healing chronic wounds of the Guadarrama Hospital.

Procedure: Extracorporeal Shockwave Therapy

Interventions

Extracorporeal Shockwave Therapy PROCEDURE

3 to 6 shock wave treatment sessions will be performed (PiezoWave 2 Control Unit Generator, classification 93/42/EEC class IIb), with a frequency of two sessions per week.

Extracorporeal Shockwave Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 years or older,
• To have a chronic wound classified as:
• pressure ulcer,
• ischemic wounds,
• neuropathic wounds,
• dehiscence of surgical wounds
• delayed current of wound healing of more than 6 weeks.
• To sign informed consent.

You may not qualify if:

• To have signs of infection observed in wound.
• Necrotic tissue.
• Tumor wounds.
• Venous thrombosis.
• Large blood vessels at lesion edges.

Sponsors & Collaborators

• Guadarrama Hospital: lead
• Puerta de Hierro University Hospital: collaborator

Study Sites (1)

Laura Martín Losada

Guadarrama, Madrid, 28440, Spain

Location

Related Publications (23)

• Berta L, Fazzari A, Ficco AM, Enrica PM, Catalano MG, Frairia R. Extracorporeal shock waves enhance normal fibroblast proliferation in vitro and activate mRNA expression for TGF-beta1 and for collagen types I and III. Acta Orthop. 2009 Oct;80(5):612-7. doi: 10.3109/17453670903316793.

  PMID: 19916698 BACKGROUND

• Chen YJ, Wang CJ, Yang KD, Kuo YR, Huang HC, Huang YT, Sun YC, Wang FS. Extracorporeal shock waves promote healing of collagenase-induced Achilles tendinitis and increase TGF-beta1 and IGF-I expression. J Orthop Res. 2004 Jul;22(4):854-61. doi: 10.1016/j.orthres.2003.10.013.

  PMID: 15183445 BACKGROUND

• Corrales Pérez, JM, Águila Pollo, MC, Vázquez Aguilera, M, Jayne Grantham, S, Ramos Sánchez A, Fernandes Ribeiro AS. (2015) Repercusión de las heridas crónicas en las unidades de rehabilitación funcional. Gerokomos [Internet]. 2015 Sep [citado 2023 Abr 08] ; 26( 3 ): 109-114.

  BACKGROUND

• Domínguez-Saavedra G, Hernández-Galván JM.(2021) Actualización en el manejo de heridas. Cir Plast. 2021;31(3):124-136. doi:10.35366/103715.

  BACKGROUND

• Fu M, Sun CK, Lin YC, Wang CJ, Wu CJ, Ko SF, Chua S, Sheu JJ, Chiang CH, Shao PL, Leu S, Yip HK. Extracorporeal shock wave therapy reverses ischemia-related left ventricular dysfunction and remodeling: molecular-cellular and functional assessment. PLoS One. 2011;6(9):e24342. doi: 10.1371/journal.pone.0024342. Epub 2011 Sep 6.

  PMID: 21915315 BACKGROUND

• Galiano R, Snyder R, Mayer P, Rogers LC, Alvarez O; Sanuwave Trial Investigators. Focused shockwave therapy in diabetic foot ulcers: secondary endpoints of two multicentre randomised controlled trials. J Wound Care. 2019 Jun 2;28(6):383-395. doi: 10.12968/jowc.2019.28.6.383.

  PMID: 31166864 BACKGROUND

• GNEAUPP (2019). Prevention and Treatment of Pressure Ulcers/Injuries: Quick Reference Guide 2019 - GNEAUPP

  BACKGROUND

• Holsapple JS, Cooper B, Berry SH, Staniszewska A, Dickson BM, Taylor JA, Bachoo P, Wilson HM. Low Intensity Shockwave Treatment Modulates Macrophage Functions Beneficial to Healing Chronic Wounds. Int J Mol Sci. 2021 Jul 22;22(15):7844. doi: 10.3390/ijms22157844.

  PMID: 34360610 BACKGROUND

• Keil H, Mueller W, Herold-Mende C, Gebhard MM, Germann G, Engel H, Reichenberger MA. Preoperative shock wave treatment enhances ischemic tissue survival, blood flow and angiogenesis in a rat skin flap model. Int J Surg. 2011;9(4):292-6. doi: 10.1016/j.ijsu.2011.01.003. Epub 2011 Jan 21.

  PMID: 21256991 BACKGROUND

• 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: 20156981 BACKGROUND

• 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: 22642362 BACKGROUND

• Mittermayr R, Hartinger J, Antonic V, Meinl A, Pfeifer S, Stojadinovic A, Schaden W, Redl H. Extracorporeal shock wave therapy (ESWT) minimizes ischemic tissue necrosis irrespective of application time and promotes tissue revascularization by stimulating angiogenesis. Ann Surg. 2011 May;253(5):1024-32. doi: 10.1097/SLA.0b013e3182121d6e.

  PMID: 21372687 BACKGROUND

• National Pressure Injury Alliance, (2019). Guia_.consulta.rapida.LPP_.Spanish.pdf (gneaupp.info) European Pressure Ulcer Advirory. Panel, National Pressure Injury Alliance. Preveión y tratamiento de las leciones/úlceras por presión. Guía de consulta rápida (edición en español)(2019). Emily Haesler

  BACKGROUND

• Ottomann C, Hartmann B, Tyler J, Maier H, Thiele R, Schaden W, Stojadinovic A. Prospective randomized trial of accelerated re-epithelization of skin graft donor sites using extracorporeal shock wave therapy. J Am Coll Surg. 2010 Sep;211(3):361-7. doi: 10.1016/j.jamcollsurg.2010.05.012. Epub 2010 Jul 14.

  PMID: 20800193 BACKGROUND

• Ottomann C, Stojadinovic A, Lavin PT, Gannon FH, Heggeness MH, Thiele R, Schaden W, Hartmann B. Prospective randomized phase II Trial of accelerated reepithelialization of superficial second-degree burn wounds using extracorporeal shock wave therapy. Ann Surg. 2012 Jan;255(1):23-9. doi: 10.1097/SLA.0b013e318227b3c0.

  PMID: 21775883 BACKGROUND

• Oyebode OA, Jere SW, Houreld NN. Current Therapeutic Modalities for the Management of Chronic Diabetic Wounds of the Foot. J Diabetes Res. 2023 Feb 10;2023:1359537. doi: 10.1155/2023/1359537. eCollection 2023.

  PMID: 36818748 BACKGROUND

• Ramon S, Espanol A, Yebra M, Morillas JM, Unzurrunzaga R, Freitag K, Gomez S, Aranzabal JR. [Current evidences in shockwave treatment. SETOC (Spanish Society of Shockwave Treatment) recommendations]. Rehabilitacion (Madr). 2021 Oct-Dec;55(4):291-300. doi: 10.1016/j.rh.2021.02.002. Epub 2021 Mar 17. Spanish.

  PMID: 33743978 BACKGROUND

• Rassweiler JJ, Scheitlin W, Goezen AS, Rassweiler-Seyfried MC. Low-energy Shockwave Therapy in the Management of Wound Healing Following Fournier's Gangrene. Eur Urol Open Sci. 2022 Sep 13;45:8-11. doi: 10.1016/j.euros.2022.08.019. eCollection 2022 Nov.

  PMID: 36131850 BACKGROUND

• RNAO. (2016). Valoración y manejo de las lesiones por presión para equipos interprofesionales (Internet) Disponible en: Pressure_Injuries_Spanish BPG.pdf

  BACKGROUND

• Schaden, W., Kölpl, C., Valentin, A., Pusch, M., & Thiele, R. (2005). Extracorporeal shockwave therapy for chronic skin lesions. In 8th International Congress of the ISMST, May 29th-June 1st (pp. 62-68).

  BACKGROUND

• Taheri P, Shahbandari M, Parvaresh M, Vahdatpour B. Extracorporeal Shockwave Therapy for Chronic Venous Ulcers: A Randomized Controlled Trial. Galen Med J. 2021 Apr 25;10:e1931. doi: 10.31661/gmj.v10i0.1931. eCollection 2021.

  PMID: 35434156 BACKGROUND

• Wang CJ, Wang FS, Yang KD, Weng LH, Hsu CC, Huang CS, Yang LC. Shock wave therapy induces neovascularization at the tendon-bone junction. A study in rabbits. J Orthop Res. 2003 Nov;21(6):984-9. doi: 10.1016/S0736-0266(03)00104-9.

  PMID: 14554209 BACKGROUND

• Zhang L, Weng C, Zhao Z, Fu X. Extracorporeal shock wave therapy for chronic wounds: A systematic review and meta-analysis of randomized controlled trials. Wound Repair Regen. 2017 Aug;25(4):697-706. doi: 10.1111/wrr.12566. Epub 2017 Oct 18.

  PMID: 28759136 BACKGROUND

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Laura Martin, RN, MSc

  Guadarrama Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Director

Model Details: Quasi-Experimental Study

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: January 18, 2024
• Study Start: November 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)