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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663519
• Other study ID #: VGFOUGSB-9725 Regional R&D
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: July 2012

Study information

• Verified date: July 2019
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Neuropathy
• Quality of Life

Intervention

Other:
• Custom made insoles 35 shore
Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
• Prefabricated insoles
Prefabricated insoles
• 55 shore Custom made insole
Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.

Locations

Country	Name	City	State
Sweden	Lundbergs Laboratory for Orthopaedic Research	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Hellstrand Tang U, Zügner 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 Endocrino — View Citation

Tang UH, Zügner 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: 10.34 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health related quality of life		every 6 months until 24 months is reached
Other	Cost and cost analysis	Calculation of costs for orthopaedic appliance in studied population	24 month
Primary	In shoe plantar pressure measurement		up to 24 months
Secondary	Gait analysis	Optical tracking system with skin-mounted markers	every 6 months until 24 months is reached

External Links

•   The Diabetic Foot - assessment and assistive devices