Trial document





This trial has been registered retrospectively.
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  DRKS00015224

Trial Description

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Title

Evaluation of the effect of foot care on the secondary prevention of foot complications - a 10-year follow-up. Follow-up of 91 patients

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Trial Acronym

FußNu10

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study evaluates the effect of foot care on the secondary prevention of foot complications in patients who participated in a controlled study on the outcome of high-risk patients with and without professional food care in the years 1997-1998. The diabetic foot syndrome often occurs as a result of poor diabetes management and is associated with significant mortality and morbidity in diabetes patients. Diabetic polyneuropathy (nerve damage) and peripheral arterial occlusive disease (decreased perfusion of the arteries in the legs) are causally involved in the occurrence of the diabetic foot syndrome. Prophylaxis after the onset and healing of foot ulcers very important as a recurrence often goes along with a high risk of amputation. Professional foot care has a high priority in the prevention. Patients will be re-examined for complications in the study. It is a retrospective analysis using the (electronic) medical records.

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Brief Summary in Scientific Language

The diabetic foot causes significant mortality and morbidity of patients with diabetes mellitus. The diabetic foot syndrome usually manifests after years of bad diabetes management. The diabetic polyneuropathy and peripheral arterial occlusive disease are causative agents for food ulcers. After the onset of a foot ulcer and its healing, the prophylaxis of recent ulcer is important to prevent the recurrence of new ulcers, as recurrences pose a high risk of amputation. A pillar of this prophylaxis is the professional foot care. In the years 1997 and 1998 a randomized, controlled study was carried out on the diabetic foot clinic at the University Hospital Graz. In this study, participants of the study conducted at that time will be included and re-examined with regard to the occurrence of complications. It is a retrospective analysis using the (electronic) medical records.

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Organizational Data

  •   DRKS00015224
  •   2018/08/08
  •   [---]*
  •   yes
  •   Approved
  •   28-075 ex 15/16, Ethikkommission der Medizinischen Universität Graz Auenbruggerplatz 2 8036 Graz
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Secondary IDs

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Health Condition or Problem studied

  •   E11.74 -  [generalization E11.7: Type 2 diabetes mellitus; With multiple complications]
  •   E10.74 -  [generalization E10.7: Type 1 diabetes mellitus; With multiple complications]
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Interventions/Observational Groups

  •   It is a retrospective analysis using the (electronic) medical records. Participants will be invited by telephone for a follow-up visit with an anamnesis to the Department of Internal Medicine, Department of Endocrinology & Diabetology. They will be examined for the occurrence of complications.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

mortality

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Secondary Outcome

- Amputation major / minor
- Recurrent ulcer
- Dialysis
- Cardiovascular events

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/01/11
  •   91
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

All patients in the Department of Internal Medicine, Division of Endocrinology and Metabolism, in 1997 and 1998 participated in a controlled study on the outcome of high-risk patients with and without professional foot care.

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Exclusion Criteria

N/A

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Addresses

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    • Universitäts Klinikum für Innere MedizinAbteilung für Endokrinologie & Diabetologie
    • Auenbruggerplatz 15
    • 8036  Graz
    • Austria
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    • Universitäts Klinikum für Innere MedizinAbteilung für Endokrinologie & Diabetologie
    • Ms.  Assoz. Prof. PD Dr.   Julia  Mader 
    • Auenbruggerplatz 15
    • 8036  Graz
    • Austria
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    • Universitäts Klinikum für Innere Medizin Abteilung für Endokrinologie & Diabetologie
    • Ms.  -  Tina  Pöttler 
    • Auenbruggerplatz 15
    • 8036  Graz
    • Austria
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Sources of Monetary or Material Support

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    • Universitätsklinikum für Innere MedizinAbteilung für Endokrinologie & Diabetologie
    • Auenbruggerplatz 15
    • 8036  Graz
    • Austria
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Status

  •   Recruiting complete, follow-up complete
  •   2016/11/10
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.