Clinical trial NCT01663519: Effectiveness of Insoles Provided to Patients With Diabetes. A Longitudinal Randomized Controlled Study in Gothenburg
Official title: Effectiveness of Insoles Provided to Diabetic Patients at Risk to Develop Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Neuropathy
Quality of Life
Keywords: Diabetic foot
Offloading
Prevention
Orthotics
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: In shoe plantar pressure measurement
timeFrame: up to 24 months
Secondary outcomes:
measure: Gait analysis
timeFrame: every 6 months until 24 months is reached
Other outcomes:
measure: Health related quality of life
timeFrame: every 6 months until 24 months is reached
measure: Cost and cost analysis
timeFrame: 24 month
Locations:
city: Gothenburg
country: Sweden
facility: Lundbergs Laboratory for Orthopaedic Research
Study officials:
affiliation: Lundbergs laboratory for Orthopaedic Research
name: Roy Tranberg, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.