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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Diabetic Foot; Neuropathy
• Intervention / Treatment: Other: Prefabricated insoles; Other: Custom made insoles 35 shore; Other: 55 shore Custom made insole

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
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Lundbergs Laboratory for Orthopaedic Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life		every 6 months until 24 months is reached
Cost and cost analysis	Calculation of costs for orthopaedic appliance in studied population	24 month

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Investigators: Study Chair: Roy Tranberg, PhD, Lundbergs Laboratory for Orthopaedic Research

Publications and helpful links

General Publications

• Hellstrand Tang U, Zugner R, Lisovskaja V, Karlsson J, Hagberg K, Tranberg R. Comparison of plantar pressure in three types of insole given to patients with diabetes at risk of developing foot ulcers - A two-year, randomized trial. J Clin Transl Endocrinol. 2014 Jul 24;1(4):121-132. doi: 10.1016/j.jcte.2014.06.002. eCollection 2014 Dec.
• Tang UH, Zugner R, Lisovskaja V, Karlsson J, Hagberg K, Tranberg R. Foot deformities, function in the lower extremities, and plantar pressure in patients with diabetes at high risk to develop foot ulcers. Diabet Foot Ankle. 2015 Jun 17;6:27593. doi: 10.3402/dfa.v6.27593. eCollection 2015.

Helpful Links

• The Diabetic Foot - assessment and assistive devices

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: August 9, 2012
• First Submitted That Met QC Criteria: August 10, 2012
• First Posted (Estimate): August 13, 2012

Study Record Updates

• Last Update Posted (Actual): July 29, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Prevention; Diabetic foot; Orthotics; Offloading
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: VGFOUGSB-9725 Regional R&D