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Shockwave Therapy in Patients With Chronic Wounds

NCT06210399 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-05-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Puerta de Hierro University Hospital

    collaborator OTHER

  • Guadarrama Hospital

    lead OTHER

Principal Investigators

  • Laura Martin, RN, MSc · Guadarrama Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06210399 on ClinicalTrials.gov