Trial document




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  DRKS00005683

Trial Description

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Title

"Smart insole for patients with diabetic neuropathy for the prevention of foot ulcers"

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Trial Acronym

Insole

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In patients with polyneuropathy skin temperature drop is not noticeable ( due to decreased blood flow to the foot under pressure load ) . The patient does not feel pain even if the load pressure and thus the reduced blood flow to the foot over a long time. Thereby, the risk for the development of foot ulcers increases. For this study, we assume that the temperature in the foot or the temperature drop under pressure , is a good holding and relevant marker for the lack of pain sensation and the Feeling of pressure . The aim should be to establish pressure and temperature curves , those limits are set using below which threatens the development of foot ulcers and submitted an optical / acoustic signal on.The present inventive insole is based on conventional , medically recommended insoles. In the surface of the insole a flat, uniformly strong depression ( profile) is incorporated into, a sensor system is inserted, in which several very thin pressure and temperature sensors are connected. The sole is designed so that the individually determined risk can be places at a temperature and pressure measurement .

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Brief Summary in Scientific Language

The aim of the project is the development and testing of an insole for diabetes patients with severe nerve damage . It should provide information that is missing due to the polyneuropathy and are used for primary ( and secondary) prevention of foot ulcerations .
Preliminary investigations have shown that, for a load pressure within about 10 minutes, the surface temperature of a foot is reduced locally by about 1K . The continuous drop in temperature is detected for 30 minutes . After short-term depressuring , the temperature rises under the foot again to the initial value. The investigations were carried out on unclothed foots or with stockings from cotton.
The sole should be a constant companion of risk patients after conditioning of the footwear and ultimately prevent diabetes damage of foot up to amputation or significantly delay and thus reduce the treatment costs (cost savings in health insurance ) .

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Organizational Data

  •   DRKS00005683
  •   2014/01/27
  •   [---]*
  •   yes
  •   Approved
  •   103/13, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1152-3510 
  •   CIV-13-06-011441 
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Health Condition or Problem studied

  •   E10 -  Insulin-dependent diabetes mellitus
  •   E11 -  Non-insulin-dependent diabetes mellitus
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Interventions/Observational Groups

  •   30 patients with sensorimotor neuropathy:
    Alternating between standing (pressure load for 5, 10 and 20 min) and in between a relief when sitting (5 min each), duplication
  •   30 healthy subjects without sensory-motor neuropathy:
    Alternating between standing (pressure load for 5, 10 and 20 min) and in between a relief when sitting (5 min each), duplication
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Testing of the pressure and temperature sensors in an insole for recording the pressure and temperature correlation under pressure loading and depressuring

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/02/03
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Inclusion criteria for the healthy subjects:

- No macroangiopathy or skin defects of the lower extremities
- No polyneuropathy any etiology
- No diabetes mellitus
- No physical deformities (amputations, foot, leg, spinal deformities, etc.)
- No neuropathic ulceration in the foot
- No heart failure St. III / IV according to NYHA
- No myocardial infarction ≤ 12 weeks ago
- Capacity to consent
- Written consent after being informed

Inclusion criteria for subjects with neuropathy:
- Diabetes mellitus type 1 or type 2
- Sensorimotor peripheral neuropathy (vibration perception by means of graduated tuning fork according to Rydel / Seiffer </ = 2/8)
- Good general condition
- Absence of foot deformities requiring orthopedic shoes
- Absence of neuropathic ulcers or other wounds
- Absence of macroangiopathy of the lower extremities

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Exclusion Criteria

Exclusion criteria for subjects with neuropathy:
- Neuropathic ulcers in the foot
- Macroangiopathy of the lower extremities
- St. heart failure III / IV according to NYHA
- Physical deformities (amputations, foot, leg, spinal deformities, etc.)
- Myocardial infarction ≤ 12 weeks ago
- Lack of capacity to consent
- Lack of written consent after being informed

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Otto-von-Guericke Universität, Medizinsiche Fakultät
    • Mr.  Prof. Dr. med.  Hermann-Josef  Rothkötter 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • IFAK System GmbH
    • Oststraße 18
    • 39114  Magdeburg
    • Germany
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    •   +49-391-544 563 11
    •   +49-391-544 563 99
    •   [---]*
    •   [---]*
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    • HSG-IMAT
    • Allmandring 9b
    • 70569  Stuttgart
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    •   +49-711-685 83712
    •   [---]*
    •   [---]*
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    • Orthofit Schuhtechnik
    • Universitätsplatz 11
    • 39104  Magdeburg
    • Germany
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    •   +49-391-5432611
    •   [---]*
    •   [---]*
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    • Universitätsklinik für Nieren- und Hochdruckkrankheiten, Diabetologie und Endokrinologie
    • Mr.  Prof. Dr. med.  Peter R.  Mertens 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Nieren- und Hochdruckkrankheiten, Diabetologie und Endokrinologie
    • Ms.  Dr. med.  Silke  Klose 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik für Nieren- und Hochdruckkrankheiten, Diabetologie und Endokrinologie
    • Mr.  Prof. Dr. med.  Peter  Mertens 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2016/05/26
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Trial Publications, Results and other Documents

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