Wound HealNCT06210399
Shockwave Therapy in Patients With Chronic Wounds
A study testing Extracorporeal Shockwave Therapy in people with Wound Heal, run by Guadarrama Hospital at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- Extracorporeal Shockwave Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- To have signs of infection observed in wound.
- Necrotic tissue.
- Tumor wounds.
- Venous thrombosis.
- Large blood vessels at lesion edges.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Extracorporeal Shockwave Therapy
- Keywords
- Extracorporeal Shockwave Therapy, Wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
The surface of the wound will be measured in centimeters. The average of the decrease will be evaluated.
Measured: 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).
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
Measured: 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.
Side effects (none, bleeding, skin redness, red spots, vasovagal syncope, paresthesia, hypesthesia, others) will be collected after the sessions.
Measured: 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).
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.
Measured: Baseline and during the intervention (up 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Nov 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-Experimental Study
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guadarrama Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Puerta de Hierro University Hospital
- Responsible party
- Principal investigator, Laura Martín Losada, Guadarrama Hospital
- Investigators
- Laura Martin, RN, MSc, Principal investigator, Guadarrama Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210399
- Sponsor's protocol ID
- 10
- Status last verified
- May 2025
- First submitted
- 21 Nov 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19916698Chen 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.
PubMed 15183445Corrales 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.
Domínguez-Saavedra G, Hernández-Galván JM.(2021) Actualización en el manejo de heridas. Cir Plast. 2021;31(3):124-136. doi:10.35366/103715.
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.
PubMed 21915315Galiano 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.
PubMed 31166864GNEAUPP (2019). Prevention and Treatment of Pressure Ulcers/Injuries: Quick Reference Guide 2019 - GNEAUPP
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.
PubMed 34360610Keil 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.
PubMed 21256991Larking 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.
PubMed 20156981Mittermayr 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.
PubMed 22642362Mittermayr 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.
PubMed 21372687National 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
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.
PubMed 20800193Ottomann 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.
PubMed 21775883
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Extracorporeal Shockwave Therapy in Patients With Chronic Wounds Hospitalized in a Medium Stay Hospital
- ClinicalTrials.gov ID
- NCT06210399
- Acronym / sponsor ID
- 10
- Conditions
- Wound Heal
- Keywords
- Extracorporeal Shockwave Therapy, Wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Guadarrama HospitalUniversity, hospital or other
- Collaborators
- Puerta de Hierro University Hospital
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-Experimental Study
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shockwave Therapy | Experimental | Procedure: Extracorporeal Shockwave TherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient aged 18 years or older,
- To have a chronic wound classified as:
- To sign informed consent.
Key exclusion criteria (5 listed)
- To have signs of infection observed in wound.
- Necrotic tissue.
- Tumor wounds.
- Venous thrombosis.
- Large blood vessels at lesion edges.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shockwave Therapy3 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. | Procedure or surgery | Extracorporeal Shockwave Therapy |
Primary outcome
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)
4 secondary outcomes
To quantify the change in the size of chronic wounds treated with shock waves
Time frame: 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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Background: PubMed 19916698Berta 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.
- Background: PubMed 15183445Chen 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.
- BackgroundCorrales 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.
- BackgroundDomínguez-Saavedra G, Hernández-Galván JM.(2021) Actualización en el manejo de heridas. Cir Plast. 2021;31(3):124-136. doi:10.35366/103715.
- Background: PubMed 21915315Fu 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.
- Background: PubMed 31166864Galiano 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.
- BackgroundGNEAUPP (2019). Prevention and Treatment of Pressure Ulcers/Injuries: Quick Reference Guide 2019 - GNEAUPP
- Background: PubMed 34360610Holsapple 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.
- Background: PubMed 21256991Keil 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.
- Background: PubMed 20156981Larking 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.
- Background: PubMed 22642362Mittermayr 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.
- Background: PubMed 21372687Mittermayr 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Martin, RN, MSc principal investigator
Guadarrama Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave Therapy in people with Wound Heal, run by Guadarrama Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease wound size area (time frame: All wounds will be measured at the end of the intervention (3 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06210399, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.