Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Burn Scar; Chronic Wound; Burn Injury; Acute Wound; Flap Disorder
• Intervention / Treatment: Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave); Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • University of Schleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Second-Degree Burn; 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); Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Experimental: Skin Excision (for Skin Graft); 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); Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Experimental: Chronic Wound; 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); Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Active Comparator: Intact Skin; 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); Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Experimental: Second-Degree Burn (repetitive); 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); Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Experimental: Skin Excision (for Skin Graft) (repetitive); 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); Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Experimental: Chronic Wound (repetitive); 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); Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Active Comparator: Intact Skin (repetitive); 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); Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Experimental: Hypertrophic burn scar; 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); Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Experimental: Hypertrophic burn scar (repetitive); 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); Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Experimental: Flap; 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); Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Experimental: Flap (repetitive); 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); Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in microcirculation (composite measure)	capillary blood flow [arbitrary units AU]; capillary blood velocity [AU]; tissue oxygen saturation [%]; relative postcapillary venous filling pressure [AU]	Baseline and 1 minute post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in microcirculation (areolar measure)	tissue oxygen saturation [%]; tissue hemoglobin index	Baseline, while and 1 minute post-dose

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: April 11, 2015
• First Posted (Estimate): April 16, 2015

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 14-266-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No