An interventional study of Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) and Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) in Burn Injury, Acute Wound and Chronic Wound, sponsored by University Hospital Schleswig-Holstein. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by University Hospital Schleswig-Holstein · Not applicable, Interventional, and Basic science
In plastic and reconstructive surgery, treatment strategies of second-degree burns, superficial wounds, hypertrophic burn scars, flaps and chronic wounds aim at reducing infection and improving microcirculation. Although previous studies indicate that extracorporeal shock wave therapy (ESWT) can accelerate wound healing, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of extracorporeal shock wave therapy on second-degree burns, superficial wounds, hypertrophic burn scars, flaps and chronic wounds in a human in-vivo setting for the first time.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 240 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University Hospital Schleswig-Holstein is the lead sponsor of 157 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
General exclusion criteria
Exclusion Criteria Groups A, B, D, E, F, H:
Anamnestic exclusion criteria
Group A (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Group B (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size must not be less than 1% of TBSA. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Group C (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Group D (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups A-C must be evident. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Group E (n=20): Consent-capable male and female patients ≥18 years of age who have sustained a second-degree burn on ≥1% and ≤30% of the surface of the body. Intervention: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Group F (n=20): Consent-capable male and female patients ≥18 years of age who require a skin excision for the purpose of a skin graft. The minimal size must not be less than 1% of TBSA. Intervention: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Group G (n=20): Consent-capable male and female patients ≥18 years of age suffering from a wound that has not yet healed ≥3 weeks. The minimal size of the wound site must not be less than 1% of TBSA. Intervention: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Group H (n=20): Consent-capable healthy male and female probands ≥18 years of age serving as sham group. None of the the criteria of groups A-C must be evident. Intervention: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Group I (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn scar. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Group J (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn scar. Intervention: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Group K (n=20): Consent-capable male and female patients ≥18 years of age who received a flap. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Group L (n=20): Consent-capable male and female patients ≥18 years of age who received a flap. Intervention: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Change in microcirculation (composite measure)
* capillary blood flow \[arbitrary units AU\] * capillary blood velocity \[AU\] * tissue oxygen saturation \[%\] * relative postcapillary venous filling pressure \[AU\]
Time frame: Baseline and 1 minute post-dose
Change in microcirculation (areolar measure)
* tissue oxygen saturation \[%\] * tissue hemoglobin index
Time frame: Baseline, while and 1 minute post-dose
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Schleswig-Holstein