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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulla Hellstrand Tang, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01663519
First received: August 9, 2012
Last updated: November 28, 2012
Last verified: August 2012
  Purpose

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 Intervention
Diabetic Foot
Neuropathy
Quality of Life
Other: Custom made insoles 35 shore
Other: Prefabricated insoles
Other: 55 shore Custom made insole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of Insoles Provided to Diabetic Patients at Risk to Develop Ulcers

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • In shoe plantar pressure measurement [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gait analysis [ Time Frame: every 6 months until 24 months is reached ] [ Designated as safety issue: No ]
    Optical tracking system with skin-mounted markers


Other Outcome Measures:
  • Health related quality of life [ Time Frame: every 6 months until 24 months is reached ] [ Designated as safety issue: No ]
  • Cost and cost analysis [ Time Frame: 24 month ] [ Designated as safety issue: No ]
    Calculation of costs for orthopaedic appliance in studied population


Enrollment: 114
Study Start Date: January 2008
Study Completion Date: July 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 9, 2012
Last Updated: November 28, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 23, 2014