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

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-12-31

Brief Summary

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A combination of diabetes and neuropathy can cause an altered gait, increased tissue stiffness, limited joint mobility, muscle weakness, foot deformities, thus leading to excessive plantar pressure. The presence of an increased plantar pressure and the loss of sensation is a serious risk factor in the risk of development of diabetic foot ulcers (DFU). Therefore, appropriate shoes and insoles are recommended to redistribute high peak pressure (PP) and reduce pressure time integral (PTI) . Shoe modifications and insoles, when used, is effective to prevent the recurrence of plantar ulcer.

The primary aim of the study was to: explore gait characteristics, kinetics and kinematics in a cohort of patients diagnosed with diabetes, with and without neuropathy, assigned to use different types of insoles. The second aim was to assess the relation between gait characteristics, kinetics and kinematics to high plantar PP and PTI. The third aim was to compare gait characteristics, kinetics and kinematics of patients with diabetes and healthy controls.

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Detailed Description

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A combination of diabetes and neuropathy can cause an altered gait, increased tissue stiffness, limited joint mobility, muscle weakness, foot deformities, thus leading to excessive plantar pressure . The presence of an increased plantar pressure and the loss of sensation is a serious risk factor in the risk of development of diabetic foot ulcers (DFU). Therefore, appropriate shoes and insoles are recommended to redistribute high peak pressure (PP) and reduce pressure time integral (PTI). Shoe modifications and insoles, when used, is effective to prevent the recurrence of plantar ulcer.

Patients presenting with mild or absence of neuropathy have lower PP compared to those having more severe stages of neuropathy. However, these findings are not unambiguous. In a study patients walked in a standardize speed of 1.2 m/s, and it was only under the first metatarsal phalangeal joint that the group with neuropathy had higher PP compared to patients with diabetes without neuropathy. In the remaining parts of the foot sole, there was no difference. In a study comparing custom-made insoles and prefabricated insoles used in a walking shoe, a cohort of patients with no history of foot ulcers was studied and there were no differences in PP for the sub groups with and without neuropathy.

More knowledge is needed regarding risk factors such as neuropathy, gait deviation and differences in kinematics and kinetics in order to prevent the onset of the "first" plantar ulcer.

Conditions

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Diabetes Diabetic Foot Plantar Ulcer Neuropathy Gait Disorder, Sensorimotor Motor Neuropathy Foot Deformities Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a 10 year follow-up of an original randomized clinical trial (RCT) study (n= 114 patients) with type 1 and type 2 diabetes. The participants were referred to the department of Prosthetics \& Orthotics (DPO) at Sahlgrenska University Hospital and were randomised to: 1) use prefabricated insoles, 2) soft custom-made insoles or 3) hard custom-made insoles. The groups were followed 2 years with follow-ups every 6 months. Data regarding plantar pressure, gait characteristics, kinetics and kinematics and presence of risk factors will be collected 10 years after inclusions. Comparisons will be made with a group of patients with diabetes being first times visitors to the Department of Prosthetics \& Orthotics.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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 DEVICE

The participants received prefabricated insoles

Custom-made insoles soft

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

Group Type EXPERIMENTAL

Soft custom-made insoles

Intervention Type DEVICE

The participants received soft custom-made insoles

Custom-made hard

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

Group Type EXPERIMENTAL

Hard custom-made insoles

Intervention Type DEVICE

The participants received hard custom-made insoles

Control group

No intervention with therapeutic insoles and/or shoes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prefabricated insoles

The participants received prefabricated insoles

Intervention Type DEVICE

Soft custom-made insoles

The participants received soft custom-made insoles

Intervention Type DEVICE

Hard custom-made insoles

The participants received hard custom-made insoles

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Intervention groups:

* To be a participant in the original RCT
* To be aged 18 years or more
* To walk without walking aid
* To understand the Swedish language
* No presence of foot ulcer

Exclusion Criteria

* Presence of foot ulcers

Control group

* To be first-time visitors to the DPO
* To be aged 18 years or more
* To walk without walking aid
* To understand the Swedish language
* No presence of foot ulcer

* Presence of foot ulcers

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No