Trial document




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  DRKS00003205

Trial Description

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Title

Effectiveness of local pressure reduction in different shoes for diabetic patients characterized by flexible and stiff sole constructions.

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

There are different shoes on the market for the prevetion of ulcers in diabetic patients . So far, there is only data available for one product. Aim of the study is to investigate the effectiveness of plantar peak pressure reduction of 3 different products on the market. Moreover the relevance of a stiff sole for the plantar peak pressure reduction will be investigated.

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Brief Summary in Scientific Language

Several investigations have demonstrated the impact of local pressure on the development of ulcers in diabetic patients. However, there is only one study published (evidence level III), reporting that with diabetic shoes characterized by a stiff sole, the rate of new ulcers is significant lower compared to normal shoes.
There are different products on the market, characterized by a stiff sole. Aim of the study is to compare these products.
In addition, the role of the stiff sole as an isolated factor for pressure reduction is somehow not investigated. Considering comfort and walking pattern, stiff soles have significant disadvantages. So far it is not clear, if the effect of local pressure reduction can be reduced to the stiff sole, or if it is possible to achieve a similar or may better pressure reduction by a semi rigid sole.
The study will include an insole pressure assessment to compare the plantar pressure in each patient in the different shoes.
30 patients with a diabetic foot syndrome including neuropathy and peripheral vascular disease will be analyzed. Patients with severe foot deformities are excluded. These are patients qualifying for a diabetic shoe according to the guidelines of the German Diabetic Association (DDG).
The analyses are done barefoot and with an insole pressure analyzing system, including static and dynamic measurements.
The patients will be supplied with a standardized diabetic sock.

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Organizational Data

  •   DRKS00003205
  •   2011/12/20
  •   [---]*
  •   yes
  •   Approved
  •   11093, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E11.74 -  [generalization E11.7: Non-insulin-dependent diabetes mellitus; With multiple complications]
  •   E10.74 -  [generalization E10.7: Insulin-dependent diabetes mellitus; With multiple complications]
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Interventions/Observational Groups

  •   Rigid sole - shoe type 1
    - three different widths
    - outsole of EVA and rubber (Softrubber)
    - soft upper (cloth, foam, leather) without a toe cup
    - soft insole for diabetic patients with 3 layers
  •   Rigid sole - shoe type 2
    - two different widths
    - light construction
    - soft upper
    - soft insole for diabetic patients with 3 layers
    - rigid outsole
  •   Semi rigid sole - shoe type 3
    - two different widths
    - light construction
    - soft upper
    - soft insole for diabetic patients with 3 layers
    - semi rigid outsole
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Static and dynamic pressure analysis - barefoot and as insole investigation in the different type of shoes (peak pressure and average pressure) Measuring system: T&T medilogic Medizintechnik GmbH, Mittelstrasse 9 D-12529 Schönefeld

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/11/21
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Patients with diabetes mellitus and the risk class II or III, which should be supplied with a diabetic protection shoe with a removable soft orthotic and, if required with orthopedic technical shoe modifications.
Risk class II (Loss of sensation, due to polyneuropathy or peripherial vascular disease)
Risk class III (ulcer in the history)

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Exclusion Criteria

Footdeformity requiring a custom made shoe. Open ulcer, gangren.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentrum für Fuss- und Sprunggelenkchirurgie Schön Klinik München Harlaching
    • Mr.  Prof. Dr.  Markus  Walther 
    • Herlachinger Straße 51
    • 81547  München
    • Germany
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    • Zentrum für Fuss- und Sprunggelenkchirurgie Schön Klinik München Harlaching
    • Mr.  Prof. Dr.  Markus  Walther 
    • Herlachinger Straße 51
    • 81547  München
    • Germany
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    • Diabetische Schwerpunktpraxis
    • Mr.  Dr. med.  Arthur  Grünerbel 
    • Bertelestraße 18
    • 81479  München
    • Germany
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Sources of Monetary or Material Support

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    • Zentrum für Fuss- und Sprunggelenkchirurgie Schön Klinik München Harlaching
    • Mr.  Prof. Dr.  Markus  Walther 
    • Herlachinger Straße 51
    • 81547  München
    • Germany
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    • Bauerfreind AG
    • Mr.  Olaf  Glindemann 
    • Triebeser Straße 16
    • 07937  Zeulenroda-Triebes
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/12/15
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Trial Publications, Results and other Documents

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