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

Diabetes Clinical Trial

— Diab10  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04054076
• Other study ID #: SU-896191
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: December 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetic Foot
• Foot Deformities
• Foot Ulcer
• Gait Disorder, Sensorimotor
• Gait Disorders, Neurologic
• Motor Neuropathy
• Neuropathy
• Plantar Ulcer
• Ulcer

Intervention

Device:
• Prefabricated insoles
The participants received prefabricated insoles
• Soft custom-made insoles
The participants received soft custom-made insoles
• Hard custom-made insoles
The participants received hard custom-made insoles

Locations

Country	Name	City	State
Sweden	Department of Prostetics & Orthotics	Gothenburg	Region Västragötaland

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health related quality of life	To assess the quality of life (SF-36 and EQ-5D-5L) in the different groups	through study completion, an average of 1 year
Other	Costs for the assistive devices	Calculation of costs (SEK and USD) for the assistive devices	through study completion, an average of 1 year
Primary	Peak pressure	To compare the differences of peak pressure (kPa) in the four groups.	through study completion, an average of 1 year
Primary	Pressure time integral	To compare the differences of pressure time integral (kPa*s) in the four groups.	through study completion, an average of 1 year
Secondary	Moment at ankle-knee-and hip joint	To compare the differences of joint moment (Nm/kg) in the four groups.	through study completion, an average of 1 year
Secondary	Speed	To compare the differences of speed (m/s) in the four groups.	through study completion, an average of 1 year
Secondary	Cadence	To compare the differences of cadence (step/min) in the four groups.	through study completion, an average of 1 year
Secondary	Stance (percent of stand phase)	To compare the differences of stance phase (%) in the four groups.	through study completion, an average of 1 year
Secondary	Range of foot-knee and hip angles (minimum to maximum)	To compare the differences of maximum angle (degree) in the four groups	through study completion, an average of 1 year
Secondary	Walking distance of 5 minutes walking	To compare the differences of 5 minutes walking(m) distance in the four groups	through study completion, an average of 1 year
Secondary	Distribution of risk grade ( the risk to develop diabetic foot ulcers 1-4(1=no risk, 4=presence of foot ulcers)	To assess the distribution of risk grade (1-4) in the four groups	through study completion, an average of 1 year
Secondary	Relation of different types of insoles and risk factors to peak pressure	To assess the influence of different types of insoles and risk factors on high peak pressure (kPa)	through study completion, an average of 1 year
Secondary	Relation of different types of insoles and risk factors to pressure time integral	To assess the influence of different types of insoles and risk factors on pressure time integral (kPa*s)	through study completion, an average of 1 year