Skip to main content
OpenTrials
Completed

NCT Number: NCT04054076

10 Years Follow-up Study of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Deformities Foot Diseases Foot Ulcer Gait Disorder, Sensorimotor Gait Disorders, Neurologic Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Motor Neuropathy Musculoskeletal Diseases Nervous System Diseases Neuritis Neurologic Manifestations Neuromuscular Diseases Neuropathy Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Plantar Ulcer Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Prostetics & Orthotics

Gothenburg, Region Västragötaland, 41285, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prefabricated insoles

Device

The participants received prefabricated insoles

Soft custom-made insoles

Device

The participants received soft custom-made insoles

Hard custom-made insoles

Device

The participants received hard custom-made insoles

Primary outcomes

  1. Peak pressure

    Time frame: through study completion, an average of 1 year

    To compare the differences of peak pressure (kPa) in the four groups.

  2. Pressure time integral

    Time frame: through study completion, an average of 1 year

    To compare the differences of pressure time integral (kPa*s) in the four groups.

Secondary outcomes

  1. Moment at ankle-knee-and hip joint

    Time frame: through study completion, an average of 1 year

    To compare the differences of joint moment (Nm/kg) in the four groups.

  2. Speed

    Time frame: through study completion, an average of 1 year

    To compare the differences of speed (m/s) in the four groups.

  3. Cadence

    Time frame: through study completion, an average of 1 year

    To compare the differences of cadence (step/min) in the four groups.

  4. Stance (percent of stand phase)

    Time frame: through study completion, an average of 1 year

    To compare the differences of stance phase (%) in the four groups.

  5. Range of foot-knee and hip angles (minimum to maximum)

    Time frame: through study completion, an average of 1 year

    To compare the differences of maximum angle (degree) in the four groups

  6. Walking distance of 5 minutes walking

    Time frame: through study completion, an average of 1 year

    To compare the differences of 5 minutes walking(m) distance in the four groups

  7. Distribution of risk grade ( the risk to develop diabetic foot ulcers 1-4(1=no risk, 4=presence of foot ulcers)

    Time frame: through study completion, an average of 1 year

    To assess the distribution of risk grade (1-4) in the four groups

  8. Relation of different types of insoles and risk factors to peak pressure

    Time frame: through study completion, an average of 1 year

    To assess the influence of different types of insoles and risk factors on high peak pressure (kPa)

  9. Relation of different types of insoles and risk factors to pressure time integral

    Time frame: through study completion, an average of 1 year

    To assess the influence of different types of insoles and risk factors on pressure time integral (kPa*s)

Other outcomes

  1. Health related quality of life

    Time frame: through study completion, an average of 1 year

    To assess the quality of life (SF-36 and EQ-5D-5L) in the different groups

  2. Costs for the assistive devices

    Time frame: through study completion, an average of 1 year

    Calculation of costs (SEK and USD) for the assistive devices

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Acronym: Diab10

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2019
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.