Effectiveness of Insoles Provided to Patients With Diabetes. A Longitudinal Randomized Controlled Study in Gothenburg

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Insoles Provided to Diabetic Patients at Risk to Develop Ulcers

Conditions
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Diabetic Foot, Neuropathy, Quality of Life

Intervention / Treatment
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* Other: Custom made insoles 35 shore
* Other: Prefabricated insoles
* Other: 55 shore Custom made insole


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: First time visitor to Dept of Prosthetics & Orthotics Diabetes Age > 18 year Be able to walk independently Be able to read and understand Swedish Exclusion Criteria: Ulcers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prefabricated insoles<br>Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material. | Other: Prefabricated insoles<br>* Prefabricated insoles<br>* Other names: Bauerfeind GloboTec® 312750501400;|
| Experimental: Custom made insoles 35 shore<br>Custom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate | Other: Custom made insoles 35 shore<br>* Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.<br>|
| Experimental: 55 shore Custom made insoles<br>Custom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate | Other: 55 shore Custom made insole<br>* Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In shoe plantar pressure measurement |  | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait analysis | Optical tracking system with skin-mounted markers | every 6 months until 24 months is reached | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic foot, Offloading, Prevention, Orthotics