Burn InjuryNCT02417779
Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy
A study testing Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) and Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) in people with Burn Injury and Acute Wound, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Injury, Acute Wound, Chronic Wound
- What is being tested?
- Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) and Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Feb 2023
- 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
- 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.
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- 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..
Who cannot join
- General exclusion criteria
- below 18 years of age
- wounds requiring artificial respiration, since consent for the study participation is unobtainable
- peripheral arterial occlusive disease
- vasculitis
- diabetes mellitus
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
About this study
Official title: 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.
- Conditions
- Burn Injury, Acute Wound, Chronic Wound, Burn Scar, Flap Disorder
- Being tested
- Extracorporeal Shock Wave Therapy (Device Name: PiezoWave), Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: Device: Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microcirculation (composite measure)
- capillary blood flow [arbitrary units AU]
- capillary blood velocity [AU]
- tissue oxygen saturation [%]
- relative postcapillary venous filling pressure [AU]
Measured: Baseline and 1 minute post-dose
Secondary outcomes (1)
Change in microcirculation (areolar measure)
- tissue oxygen saturation [%]
- tissue hemoglobin index
Measured: Baseline, while and 1 minute post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2023
- Study completionFeb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Kisch, University Hospital Schleswig-Holstein
- Investigators
- Tobias Kisch, MD, Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417779
- Sponsor's protocol ID
- 14-266-1
- Status last verified
- Feb 2023
- First submitted
- 12 Mar 2015
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Extracorporeal Shock Wave Therapy in Cutaneous Microcirculation of Different Wounds
- ClinicalTrials.gov ID
- NCT02417779
- Acronym / sponsor ID
- 14-266-1
- Conditions
- Burn Injury, Acute Wound, Chronic Wound, Burn Scar, Flap Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Feb 2023 (actual)
- Study completion
- Feb 2023 (actual)
- First posted
- 16 Apr 2015 (estimated)
- 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Second-Degree Burn | Experimental | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)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) |
| Skin Excision (for Skin Graft) | Experimental | 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) |
| Chronic Wound | Experimental | 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) |
| Intact Skin | Active comparator | 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) |
| Second-Degree Burn (repetitive) | Experimental | Device: Repetitive 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) |
| Skin Excision (for Skin Graft) (repetitive) | Experimental | 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) |
| Chronic Wound (repetitive) | Experimental | 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) |
| Intact Skin (repetitive) | Active comparator | 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) |
| Hypertrophic burn scar | Experimental | Device: 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) |
| Hypertrophic burn scar (repetitive) | Experimental | Device: Repetitive 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) |
| Flap | Experimental | Device: 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) |
| Flap (repetitive) | Experimental | Device: Repetitive 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (14 listed)
- General exclusion criteria
- below 18 years of age
- wounds requiring artificial respiration, since consent for the study participation is unobtainable
- peripheral arterial occlusive disease
- vasculitis
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 Shock Wave Therapy (Device Name: PiezoWave)Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device | Chronic Wound, Flap, Hypertrophic burn scar, Intact Skin, Second-Degree Burn, Skin Excision (for Skin Graft) |
| Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device | Chronic Wound (repetitive), Flap (repetitive), Hypertrophic burn scar (repetitive), Intact Skin (repetitive), Second-Degree Burn (repetitive), Skin Excision (for Skin Graft) (repetitive) |
Primary outcome
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]
1 secondary outcome
Change in microcirculation (areolar measure)
Time frame: Baseline, while and 1 minute post-dose
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 24 Feb 2023.
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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.
Tobias Kisch, MD principal investigator
University Hospital Schleswig-Holstein
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 Shock Wave Therapy (Device Name: PiezoWave) and Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) in people with Burn Injury and Acute Wound, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 12 inclusion and 14 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 24 Feb 2023. 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 Germany. 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?
Change in microcirculation (composite measure) (time frame: Baseline and 1 minute post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2023.