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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Diabetic Foot; Foot Ulcer; Foot Deformities; Neuropathy; Gait Disorder, Sensorimotor; Plantar Ulcer; Motor Neuropathy
• Intervention / Treatment: Device: Prefabricated insoles; Device: Soft custom-made insoles; Device: Hard custom-made insoles

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Region Västragötaland
    • Gothenburg, Region Västragötaland, Sweden, 41285
      • Department of Prostetics & Orthotics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prefabricated insoles; Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.	Device: Prefabricated insoles; The participants received prefabricated insoles
Experimental: Custom-made insoles soft; Custom-made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate.	Device: Soft custom-made insoles; The participants received soft custom-made insoles
Experimental: Custom-made hard; Custom-made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate.	Device: Hard custom-made insoles; The participants received hard custom-made insoles
No Intervention: Control group; No intervention with therapeutic insoles and/or shoes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak pressure	To compare the differences of peak pressure (kPa) in the four groups.	through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Speed	To compare the differences of speed (m/s) in the four groups.	through study completion, an average of 1 year
Cadence	To compare the differences of cadence (step/min) in the four groups.	through study completion, an average of 1 year
Stance (percent of stand phase)	To compare the differences of stance phase (%) in the four groups.	through study completion, an average of 1 year
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Costs for the assistive devices	Calculation of costs (SEK and USD) for the assistive devices	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Investigators: Study Director: Björn Stålgren, BSc, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: August 10, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: orthotics; kinematics; kinetics
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Skin Diseases; Neurologic Manifestations; Endocrine System Diseases; Congenital Abnormalities; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetic Neuropathies; Foot Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Lower Extremity Deformities, Congenital; Diabetes Mellitus; Diabetic Foot; Foot Ulcer; Ulcer; Gait Disorders, Neurologic; Foot Deformities; Foot Deformities, Congenital
• Other Study ID Numbers: SU-896191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No