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NCT04605900

Impact of Therapeutic Footwear and Plantar Orthoses on Diabetic Neuropathic Foot in Quality of Life and Functionality

Completed NA Last updated 30 October 2020
What this trial tests

NA trial testing Orthopedic Footwear in Diabetes Mellitus, Type 2 in 43 participants. Completed in 21 May 2018.

Timeline
13 March 2017
Primary endpoint
4 January 2018
21 May 2018

Quick facts

Lead sponsorUniversidade do Algarve
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment43
Start date13 March 2017
Primary completion4 January 2018
Estimated completion21 May 2018
Sites1 location across Portugal

Drugs / interventions tested

Conditions studied

Sponsor

Universidade do Algarve

Who can join

Adults 40 to 80, any sex, with Diabetes Mellitus, Type 2 or Diabetic Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study determines the effectiveness of plantar orthoses and custom-made orthopedic footwear in functional level and quality of life of persons with diabetes type 2 and diabetic peripheral neuropathy. This study is important due the loss of protective sensation, feet are vulnerable to minor trauma caused by plantar pressure as well as mechanical and thermal injuries. Thus, Plantar Orthoses become necessary to reduce PP and align the foot. Additionally, it is known that footwear is the most frequent cause of diabetic foot injury, since ulceration is frequently a consequence of the continuous trauma provoked by inadequate footwear. For a higher efficacy in the treatment of the foot, it is also necessary to use custom-made orthopedic footwear, indicated in the treatment of foot pathologies. The lack of studies that evaluate the impact of this treatment on clinical measures such as quality of life and functional level, led to the development of this study, comparing a standard treatment (standard footwear and plantar orthoses) with an optimal treatment suggested in diabetic foot guidelines (therapeutic footwear and plantar orthoses).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

Other Universidade do Algarve trials

Trials by the same sponsor.

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Data sources for this page

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