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Clinical Trials/ISRCTN87231372
ISRCTN87231372
Completed
N/A

The clinical and cost effectiveness of footwear and orthotic therapy in the management of the neuropathic diabetic foot - a single blind randomised controlled trial

Record Provided by the NHSTCT Register - 2006 Update - Department of Health0 sites130 target enrollmentSeptember 29, 2006
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Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Enrollment
130
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 29, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional

Investigators

Sponsor
Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Eligibility Criteria

Inclusion Criteria

  • •1\. The subject must be diagnosed as type I or II diabetic
  • •2\. The subject must be identified as neuropathic and at risk of ulceration
  • •3\. The subject must not currently be suffering from any lower limb vascular or neuropathic ulceration identified by scoring Grade 0 on the Wagner classification for foot ulcer
  • •4\. The subject must be ambulant. Must be able to walk a minimum of approximately 10 metres unaided
  • •5\. The subject must be willing to comply with the requirements of the study

Exclusion Criteria

  • •1\. Subjects with current ulceration or recently healed less than 6 months prior to enrolling onto the study (as the focus of the study is preventative ulcer management rather than treatment)
  • •2\. Subjects with severe fixed midfoot or rearfoot deformity ie Charcot joint (subjects would be unsuitable for prefabricated insoles and non\-bespoke footwear)
  • •3\. Subjects with a history of bone and joint surgery of the lower limb including amputation (could lead to alteration in gait kinetics and may not be suitable for non bespoke insoles and footwear)
  • •4\. Subjects lacking the ability to comprehend simple instructions and comply with the study protocols and procedures (including those not able to read printed English)
  • •5\. Allied Health Professional students as they may be considered to have a dependant relationship with the investigator
  • •6\. Subjects diagnosed as neuropathic caused by pathology other than diabetes

Outcomes

Primary Outcomes

Not specified

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