Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy

NCT02417779 | Completed

• 1 other identifier: 14-266-1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burn Injury; Acute Wound; Chronic Wound; Burn Scar; Flap Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in microcirculation (areolar measure)

  Baseline, while and 1 minute post-dose

Study Arms (12)

Second-Degree Burn

EXPERIMENTAL

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)

Skin Excision (for Skin Graft)

EXPERIMENTAL

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)

Chronic Wound

EXPERIMENTAL

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)

Intact Skin

ACTIVE COMPARATOR

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)

Second-Degree Burn (repetitive)

EXPERIMENTAL

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)

Skin Excision (for Skin Graft) (repetitive)

EXPERIMENTAL

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)

Chronic Wound (repetitive)

EXPERIMENTAL

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)

Intact Skin (repetitive)

ACTIVE COMPARATOR

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)

Hypertrophic burn scar

EXPERIMENTAL

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)

Hypertrophic burn scar (repetitive)

EXPERIMENTAL

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)

Flap

EXPERIMENTAL

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)

Flap (repetitive)

EXPERIMENTAL

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)

Interventions

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) DEVICE

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Chronic Wound; Flap; Hypertrophic burn scar; Intact Skin; Second-Degree Burn; Skin Excision (for Skin Graft)

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) DEVICE

Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Chronic Wound (repetitive); Flap (repetitive); Hypertrophic burn scar (repetitive); Intact Skin (repetitive); Second-Degree Burn (repetitive); Skin Excision (for Skin Graft) (repetitive)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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..

You may not qualify if:

• below 18 years of age
• wounds requiring artificial respiration, since consent for the study participation is unobtainable
• peripheral arterial occlusive disease
• vasculitis
• diabetes mellitus
• chronic kidney or liver disease
• cardiac dysfunction
• arterial hypo- or hypertension
• ongoing immunosuppressive or chemotherapy treatment
• drug abuse
• systemic skin diseases
• systemic and local cortisone therapy

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

MeSH Terms

Conditions

Burns

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Tobias Kisch, MD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: April 16, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

DE (1)