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

Sahlgrenska University Hospital

Status: Completed

Conditions: Diabetic Foot; Quality of Life; Neuropathy

Treatments: Other: 55 shore Custom made insole; Other: Prefabricated insoles; Other: Custom made insoles 35 shore

Study type: Interventional

Funder types: Other

Identifiers

NCT01663519

VGFOUGSB-9725 Regional R&D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 3 patient groups

Prefabricated insoles

Experimental group

Description:

Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.

Treatment:

Other: Prefabricated insoles

Custom made insoles 35 shore

Experimental group

Description:

Custom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate

Treatment:

Other: Custom made insoles 35 shore

55 shore Custom made insoles

Experimental group

Description:

Custom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate

Treatment:

Other: 55 shore Custom made insole