Shockwave Therapy in Patients With Chronic Wounds

January 15, 2024 updated by: Laura Martín Losada, Guadarrama Hospital

Effectiveness of Extracorporeal Shockwave Therapy in Patients With Chronic Wounds Hospitalized in a Medium Stay Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Recruitment: the research team will recruit participants who meet inclusion criteria and do not present exclusion criteria, during the first 48 hours of admission to the functional recovery unit. A member of the team will inform and invite the subject or his or her legal representative to participate in the study. The information sheet will be given to the patient and after accepting, he/she has to sign the specific informed consent for the study and the authorization to take images. At that time, the completion of the Data Collection Notebook will begin, which has been prepared ad hoc by the research team. In order to guarantee the confidentiality of the personal data, they will be coded by dissociating the identifying and personal data from those necessary for the configuration of variables. To this end, the personal identity carry out a coding process of the units of analysis. In the event that the same patient has more than one wound that can be included in the study, a data collection notebook will be used for each wound, indicating its location and using the same coding, because the coding number will be associated with each patient.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extracorporeal Shockwave Therapy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease wound size area
Time Frame: All wounds will be measured at the end of the intervention (3 weeks).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To quantify the change in the size of chronic wounds treated with shock waves
Time Frame: at the end of the intervention (3 weeks)
The surface of the wound will be measured in centimeters. The average of the decrease will be evaluated.
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).
Time Frame: at the end of the intervention (3 weeks)
The demographic (aged, sex) and clinic (urinary incontinence, faecal incontinence, personal history, Barthel Index, Norton Scale, blood albumin, smoking habits, type of wound, location of wound, clinical course) variables will be compared with the main variable
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.
Time Frame: at the end of the intervention (3 weeks)
Side effects (none, bleeding, skin redness, red spots, vasovagal syncope, paresthesia, hypesthesia, others) will be collected after the sessions.
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).
Time Frame: Baseline and during the intervention (up 3 weeks)
Pain will be assessed baseline and during the shockwave session with Visual Analogue Scale (VAS) or Pain Assesment in Advanced Dementia Scale (PAINAD). The tool will be used depending on the patients' cognitive status. VAS and PAINAD scales measure fron 0 to 10 being 0 without pain and 10 the worst pain possible.
Baseline and during the intervention (up 3 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guadarrama Hospital

Collaborators

Puerta de Hierro University Hospital

Investigators

  • Principal Investigator: Laura Martin, RN, MSc, Guadarrama Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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