10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes (Diab10)

Sahlgrenska University Hospital

Status: Completed

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

Treatments: Device: Prefabricated insoles; Device: Soft custom-made insoles; Device: Hard custom-made insoles

Study type: Interventional

Funder types: Other

Identifiers

NCT04054076

SU-896191

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion Criteria:

• Presence of foot ulcers

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 4 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:

Device: Prefabricated insoles

Custom-made insoles soft

Experimental group

Description:

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

Treatment:

Device: Soft custom-made insoles

Custom-made hard

Experimental group

Description:

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

Treatment:

Device: Hard custom-made insoles

Control group

No Intervention group

Description:

No intervention with therapeutic insoles and/or shoes.