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NCT Number: NCT02417779

Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy

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.

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Key information

Conditions

Burn Injury Acute Wound Burn Scar Burns Chronic Wound Flap Disorder Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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.
  • 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 of the skin-graft donor site must not be less than 1% of TBSA.
  • 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.
  • 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. No soft tissue injury must be evident.
  • 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.
  • 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 of the skin-graft donor site must not be less than 1% of TBSA.
  • 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.
  • 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 E-G must be evident. No soft tissue injury must be evident.
  • Group I (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn scar.
  • Group J (n=20): Consent-capable male and female patients ≥18 years of age suffering from a hypertrophic burn scar.
  • Group K (n=20): Consent-capable male and female patients ≥18 years of age who received a flap.
  • Group L (n=20): Consent-capable male and female patients ≥18 years of age who received a flap..

Exclusion criteria

General exclusion criteria

  • below 18 years of age
  • wounds requiring artificial respiration, since consent for the study participation is unobtainable

Exclusion criteria

Groups A, B, D, E, F, H:

  • peripheral arterial occlusive disease
  • vasculitis
  • diabetes mellitus
  • chronic kidney or liver disease
  • cardiac dysfunction
  • arterial hypo- or hypertension

Anamnestic exclusion criteria

  • ongoing immunosuppressive or chemotherapy treatment
  • drug abuse
  • systemic skin diseases
  • systemic and local cortisone therapy

Treatment and study plan

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Device

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Device

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Primary outcomes

  1. Change in microcirculation (composite measure)

    Time frame: Baseline and 1 minute post-dose

    • capillary blood flow [arbitrary units AU]
    • capillary blood velocity [AU]
    • tissue oxygen saturation [%]
    • relative postcapillary venous filling pressure [AU]

Secondary outcomes

  1. Change in microcirculation (areolar measure)

    Time frame: Baseline, while and 1 minute post-dose

    • tissue oxygen saturation [%]
    • tissue hemoglobin index

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

Effects of Extracorporeal Shock Wave Therapy in Cutaneous Microcirculation of Different Wounds

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Apr 16, 2015
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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