Effectiveness of Insoles Provided to Patients With Diabetes. A Longitudinal Randomized Controlled Study in Gothenburg
1 other identifier
interventional
114
1 country
1
Brief Summary
Introduction: Insoles and shoes are frequently prescribed to prevent foot ulcers in patients at risk of diabetes. A combination of neuropathy and foot deformities raises the risk from 1% to between 4-7% according to the Swedish National Board of Health and Welfare, Guidelines Diabetes Care 2010. Preventative care, which includes foot care, annual inspection of the feet, education and prescription of insoles in combination with well fitting shoes are supposed to decrease the risk of ulcers and prevent amputation. Further research is, however, needed to evaluate the effectiveness of these commonly prescribed insoles. The aim of this study is to compare three different types of insoles with respect to pressure distribution. Every 6 months follow-up is assessed until 24 months is reached.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 9, 2012
CompletedFirst Posted
Study publicly available on registry
August 13, 2012
CompletedJuly 29, 2019
July 1, 2019
4.1 years
August 9, 2012
July 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In shoe plantar pressure measurement
up to 24 months
Secondary Outcomes (1)
Gait analysis
every 6 months until 24 months is reached
Other Outcomes (2)
Health related quality of life
every 6 months until 24 months is reached
Cost and cost analysis
24 month
Study Arms (3)
Prefabricated insoles
EXPERIMENTALPrefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.
Custom made insoles 35 shore
EXPERIMENTALCustom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate
55 shore Custom made insoles
EXPERIMENTALCustom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate
Interventions
Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
Prefabricated insoles
Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
Eligibility Criteria
You may qualify if:
- First time visitor to Dept of Prosthetics \& Orthotics
- Diabetes
- Age \> 18 year
- Be able to walk independently
- Be able to read and understand Swedish
You may not qualify if:
- Ulcers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lundbergs Laboratory for Orthopaedic Research
Gothenburg, 413 45, Sweden
Related Publications (2)
Hellstrand Tang U, Zugner R, Lisovskaja V, Karlsson J, Hagberg K, Tranberg R. Comparison of plantar pressure in three types of insole given to patients with diabetes at risk of developing foot ulcers - A two-year, randomized trial. J Clin Transl Endocrinol. 2014 Jul 24;1(4):121-132. doi: 10.1016/j.jcte.2014.06.002. eCollection 2014 Dec.
PMID: 29159093RESULTTang UH, Zugner R, Lisovskaja V, Karlsson J, Hagberg K, Tranberg R. Foot deformities, function in the lower extremities, and plantar pressure in patients with diabetes at high risk to develop foot ulcers. Diabet Foot Ankle. 2015 Jun 17;6:27593. doi: 10.3402/dfa.v6.27593. eCollection 2015.
PMID: 26087865RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Roy Tranberg, PhD
Lundbergs laboratory for Orthopaedic Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Certified Prosthetist & Orthotist
Study Record Dates
First Submitted
August 9, 2012
First Posted
August 13, 2012
Study Start
January 1, 2008
Primary Completion
February 1, 2012
Study Completion
July 1, 2012
Last Updated
July 29, 2019
Record last verified: 2019-07