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

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ClinicalTrials.gov Identifier: NCT01663519
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Ulla Hellstrand Tang, Sahlgrenska University Hospital, Sweden

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Neuropathy Quality of Life Other: Custom made insoles 35 shore Other: Prefabricated insoles Other: 55 shore Custom made insole Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Insoles Provided to Diabetic Patients at Risk to Develop Ulcers
Study Start Date : January 2008
Actual Primary Completion Date : February 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Prefabricated insoles
Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.
Other: Prefabricated insoles
Prefabricated insoles
Other Name: Bauerfeind GloboTec® 312750501400

Experimental: Custom made insoles 35 shore
Custom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate
Other: Custom made insoles 35 shore
Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.

Experimental: 55 shore Custom made insoles
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.




Primary Outcome Measures :
  1. In shoe plantar pressure measurement [ Time Frame: up to 24 months ]

Secondary Outcome Measures :
  1. Gait analysis [ Time Frame: every 6 months until 24 months is reached ]
    Optical tracking system with skin-mounted markers


Other Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663519


Locations
Sweden
Lundbergs Laboratory for Orthopaedic Research
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Study Chair: Roy Tranberg, PhD Lundbergs laboratory for Orthopaedic Research

Additional Information:
Responsible Party: Ulla Hellstrand Tang, Certified Prosthetist & Orthotist, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01663519     History of Changes
Other Study ID Numbers: VGFOUGSB-9725 Regional R&D
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014

Keywords provided by Ulla Hellstrand Tang, Sahlgrenska University Hospital, Sweden:
Diabetic foot
Offloading
Prevention
Orthotics

Additional relevant MeSH terms:
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies