Trial document




drksid header

  DRKS00006236

Trial Description

start of 1:1-Block title

Title

Extracorporeal Shock Wave Therapy for secondary wound healing of diabetic foot syndrome – ESWT

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ESWT

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The standard treatment of the diabetic foot syndrome contains the optimal setting of the blood glucose, improvement of a circulatory disorder and a standardized local therapy like pressure discharge of the wound,
wound cleansing and humid treatment of wound. Thereby about 60% of the wounds heal within 20 weeks. In this trial the basic treatment is complemented by shock wave therapy to improve the wound healing. By the combination therapy the wounds can heal within a shorter period.
The expected effect of the extra corporals shock wave therapy (ESWT) is a decrease of wounds' size and an improvement in the healing process.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This study was planned to investigate the opportunity of introducing the ESWT in the treatment of chronic wounds. Patients with diabetic foot syndrome will be treated additional with the linearly focused shock wave (FBL10x5G2, medical cart PiezoDerm, Fa. Richard Wolf). The extracorporeal shock wave therapy (ESWT) is an established, very effective method of treatment. High-energy sound waves are produced and passed on tissues by a tube.
The standard treatment of the diabetic foot syndrome contains the optimal setting of the blood glucose, improvement of a circulatory disorder and a standardized local therapy like pressure discharge of the wound,
wound cleansing and humid treatment of wound. Thereby about 60% of the wounds heal within 20 weeks. In this trial the basic treatment is complemented by shock wave therapy to improve the wound healing. By the combination therapy the wounds can heal within a shorter period.
The expected effect of the extracorporeal shock wave therapy (ESWT) is a decrease of wounds' size and an improvement in the healing process. The linear focused device FBL10x5G2 is licensed since the end of 2013 especially also for diabetic ulcers.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006236
  •   2014/06/18
  •   [---]*
  •   yes
  •   Approved
  •   66/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   CIV-14-02-011880 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   E10.74 -  [generalization E10.7: Insulin-dependent diabetes mellitus; With multiple complications]
  •   E14 -  Unspecified diabetes mellitus
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Standard therapy complemented Shock Wave Therapy.
    In this trial the standard treatment of the diabetic foot syndrome is complemented by shock wave therapy to improve the wound healing. By the combination therapy the wounds can heal within a shorter period.The expected effect of the extra corporals shock wave therapy (ESWT) is a decrease of wounds' size and an improvement in the healing process.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Assessment whether ESWT with the linear focused device FBL10x5G2 improves secondary wound healing:
- measurement of the wound area by photo planimetry (in % and mm2)
- analyzing the rate of wound healing as reduction of the lesion divided by the initial area (in percent) in the treatment and follow up period (in %)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- percentage of comlete wound closure .
- tissue oxygenation and microvascular blood flow at wound border and within the wound by O2C measurement
- tissue temperature of the wound bed outside and within the wound by thermography (IR-Kamera Fluke Ti25).
-bactericidal effect: change in microbial count/ swab culture
-percentage of change in pain symptoms on VAS scale 1 – 10
- increased angiogenesis and increased growth factors in wound biopsy

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/04/17
  •   15
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   19   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

patients with diabetic foot syndrome:
-chronic wound since at least 4 weeks
- Wagner stage 1-2
-ABI (ankle-brachial-index) 0.7-1.2
- Patients with Diabetic mellitus receive a therpaiy HbA1c<=7,5%
- appropriate pressure relief
General inclusion criteria:
-signed declaration of informed consent and data protection
-males and females
-older than 18 years

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

-Presence of an ABI (=Ankle Brachial Index) of < 0.7 > 1,2
- patient with malignant disease
- Wagner stage 3-5
- osteitis/Osteomyelitis in wound region
- untreated wound infektion (leukocytes>12 000/miicroliter)
- General exclusion criteria:
- pregnancy
- participation in other clinical studies either concurrently or within the last 30 days
- Noncompliance (Patient does not wear the shoes, does not carry out local therapy or terminates it,
- Evidence of any major life-threatening or serious medical condition (sytemic infection)
- Heart pacemaker and implanted defibrillator

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Leitender Ärztliche Direktor Universitätsklinikum Freiburg
    • Mr.  Prof. Dr.  J.R.  Siewert 
    • HugstetterStr. 49
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   0761-270-18060
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Fa. Richard Wolf GmbH
    • Mr.  Werner  Krauss 
    • Pforzheimer Str. 32
    • 75438  Knittlingen
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Abteilung für Allgemein und Viszeralchirurgie Chirurgische Universitätsklinik Freiburg
    • Mr.  Dr.  Bernd  Jänigen 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Abteilung für Allgemein und Viszeralchirurgie Chirurgische Universitätsklinik Freiburg
    • Mr.  Dr.  Bernd  Jänigen 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Fa. Richard Wolf GmbH
    • Mr.  Werner  Krauss 
    • Pforzheimer Str. 32
    • 75438  Knittlingen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting stopped after recruiting started
  •   2018/03/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.