NCT06210399

Shockwave Therapy in Patients With Chronic Wounds

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Guadarrama Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Wound Heal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2024-01-18
• Last updated: 2025-05-25

Locations

1 site across 1 country: Spain