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Completed

NCT Number: NCT01663519

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

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.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Neuropathy Quality of Life Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lundbergs Laboratory for Orthopaedic Research

Gothenburg, 413 45, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Custom made insoles 35 shore

Other

Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.

Prefabricated insoles

Other

Prefabricated insoles

Other names: Bauerfeind GloboTec® 312750501400

55 shore Custom made insole

Other

Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.

Primary outcomes

  1. In shoe plantar pressure measurement

    Time frame: up to 24 months

Secondary outcomes

  1. Gait analysis

    Time frame: every 6 months until 24 months is reached

    Optical tracking system with skin-mounted markers

Other outcomes

  1. Health related quality of life

    Time frame: every 6 months until 24 months is reached

  2. Cost and cost analysis

    Time frame: 24 month

    Calculation of costs for orthopaedic appliance in studied population

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 13, 2012
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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