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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes

NCT04054076

Diabetes Diabetic Foot Plantar Ulcer +5 more

COMPLETED NA

Thickness-Varied Soft Surface on Shoe-Insoles Based on In-Shoe Pressure Measurement

NCT06679192

Diabetes Mellitus

COMPLETED NA

A Comparison of Insoles Used to Prevent Neuropathic Diabetic Foot Ulceration

NCT00999635

Diabetes Neuropathic Foot

COMPLETED PHASE2/PHASE3

Multi-layer Insoles for a Patient-specific Approach to Shear and Pressure Reduction in Diabetes-related Foot Ulcer

NCT01844479

Diabetic Foot Ulcer Diabetic Foot

COMPLETED NA

Insole Optimisation for Ulcer Prevention: a Feasibility Trial

NCT01948479

Diabetic Neuropathic Past Ulceration

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Foot Neuropathy Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prefabricated insoles

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

Group Type EXPERIMENTAL

Prefabricated insoles

Intervention Type OTHER

Prefabricated insoles

Custom made insoles 35 shore

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

Group Type EXPERIMENTAL

Custom made insoles 35 shore

Intervention Type OTHER

Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.

55 shore Custom made insoles

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

Group Type EXPERIMENTAL

55 shore Custom made insole

Intervention Type OTHER

Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Custom made insoles 35 shore

Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.

Intervention Type OTHER

Prefabricated insoles

Intervention Type OTHER

55 shore Custom made insole

Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bauerfeind GloboTec® 312750501400

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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