An interventional study of Custom made insoles 35 shore and Prefabricated insoles in Diabetic Foot, Neuropathy and Quality of Life, sponsored by Sahlgrenska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-29.
Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Prevention
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.
Patients included in the study were randomized into 3 different groups. Group number 1 and 2 got custom made insoles out of EVA (Ethyl Vinyl Acetate) with different hardness 35 and 55 shore respectively. Group nr 3 got prefabricated insole with support of the medial arch and in the forefoot. The top layer was covered with a 2 mm cushioned material, 25 shore, made out of microcellular urethane. All patients were recommended to wear good walking shoes with a semi rigid outer sole and stable heel counter. One and the same technician made the casting and fabricated the insoles as well as delivered the devices. Deliverance occured 2-3 weeks after the first visit.
At deliverance base line measurement was assessed.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 114 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.
Other: Prefabricated insoles
Custom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate
Other: Custom made insoles 35 shore
Custom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate
Other: 55 shore Custom made insole
Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
Prefabricated insoles
Also known as: Bauerfeind GloboTec® 312750501400
Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
In shoe plantar pressure measurement
Time frame: up to 24 months
Gait analysis
Optical tracking system with skin-mounted markers
Time frame: every 6 months until 24 months is reached
Health related quality of life
Time frame: every 6 months until 24 months is reached
Cost and cost analysis
Calculation of costs for orthopaedic appliance in studied population
Time frame: 24 month
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Sahlgrenska University Hospital