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Clinical Trials/ISRCTN50646165
ISRCTN50646165
Completed
N/A

The effectiveness of preventive podiatric care versus treatment as usual to reduce the number of foot ulcers in diabetic patients with polyneuropathy: a randomised controlled trial

niversity Maastricht (UM) (The Netherlands)0 sites562 target enrollmentJune 10, 2010
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ConditionsDiabetic footNutritional, Metabolic, EndocrineNon-insulin-dependent diabetes mellitus

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetic foot
Sponsor
niversity Maastricht (UM) (The Netherlands)
Enrollment
562
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 10, 2010
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity Maastricht (UM) (The Netherlands)

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients aged over 18 years, either sex
  • •2\. Diabetes mellitus
  • •3\. Signs of peripheral polyneuropathy. Polyneuropathy is defined as absence of pressure sensation (10 gram Semmes Weinstein monofilament) and/or absence of the vibration perception sense (128 Hertz tuning fork).

Exclusion Criteria

  • •1\. Polyneuropathy not related to diabetes
  • •2\. Type 1 diabetes with a duration less than 10 years
  • •3\. An active foot ulcer or a healed ulcer in the past year
  • •4\. Severe peripheral arterial disease (ankle pressure less than 50 mmHg measured with a hand held Doppler)
  • •5\. Foot surgery or peripheral bypass surgery during the past year
  • •6\. Rheumatoid disease and renal replacement therapy
  • •7\. Patients should not have consulted a podiatrist in the past year

Outcomes

Primary Outcomes

Not specified

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