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

NCT04054076 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2022-05-05

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Prefabricated insoles

The participants received prefabricated insoles

DEVICE

Soft custom-made insoles

The participants received soft custom-made insoles

DEVICE

Hard custom-made insoles

The participants received hard custom-made insoles

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Björn Stålgren, BSc · Sahlgrenska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-01-31
Completion
2021-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04054076 on ClinicalTrials.gov