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

Brief Title

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

Official Title

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

Brief 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.
    

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


Primary Outcome

Peak pressure

Secondary Outcome

 Moment at ankle-knee-and hip joint

Condition

Diabetes

Intervention

Prefabricated insoles

Study Arms / Comparison Groups

 Prefabricated insoles
Description:  Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

224

Start Date

January 1, 2020

Completion Date

December 2021

Primary Completion Date

January 2021

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Björn Stålgren, BSc, 0046706397913, [email protected]

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT04054076

Organization ID

SU-896191


Responsible Party

Principal Investigator

Study Sponsor

Sahlgrenska University Hospital, Sweden


Study Sponsor

Björn Stålgren, BSc, Study Director, Sahlgrenska University Hospital, Sweden


Verification Date

October 2020