Shockwave Therapy in Patients With Chronic Wounds

G

Guadarrama Hospital

Status

Enrolling

Conditions

Wound Heal

Treatments

Procedure: Extracorporeal Shockwave Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06210399
10

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Extracorporeal Shockwave Therapy
Experimental group
Description:
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.
Treatment:
Procedure: Extracorporeal Shockwave Therapy

Trial contacts and locations

1

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Central trial contact

Yunia H Labrada, MD; Laura Martín, RN, MSc

Data sourced from clinicaltrials.gov

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