10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes (Diab10)
Primary Purpose
Diabetes, Diabetic Foot, Plantar Ulcer
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Prefabricated insoles
Soft custom-made insoles
Hard custom-made insoles
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes focused on measuring orthotics, kinematics, kinetics
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
Sites / Locations
- Department of Prostetics & Orthotics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Prefabricated insoles
Custom-made insoles soft
Custom-made hard
Control group
Arm Description
Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.
Custom-made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate.
Custom-made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate.
No intervention with therapeutic insoles and/or shoes.
Outcomes
Primary Outcome Measures
Peak pressure
To compare the differences of peak pressure (kPa) in the four groups.
Pressure time integral
To compare the differences of pressure time integral (kPa*s) in the four groups.
Secondary Outcome Measures
Moment at ankle-knee-and hip joint
To compare the differences of joint moment (Nm/kg) in the four groups.
Speed
To compare the differences of speed (m/s) in the four groups.
Cadence
To compare the differences of cadence (step/min) in the four groups.
Stance (percent of stand phase)
To compare the differences of stance phase (%) in the four groups.
Range of foot-knee and hip angles (minimum to maximum)
To compare the differences of maximum angle (degree) in the four groups
Walking distance of 5 minutes walking
To compare the differences of 5 minutes walking(m) distance in the four groups
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
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)
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)
Full Information
NCT ID
NCT04054076
First Posted
July 25, 2019
Last Updated
May 4, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT04054076
Brief Title
10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes
Acronym
Diab10
Official Title
10 Years Follow-up of Gait Characteristics, Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetic Foot, Plantar Ulcer, Neuropathy, Gait Disorder, Sensorimotor, Motor Neuropathy, Foot Deformities, Foot Ulcer
Keywords
orthotics, kinematics, kinetics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a 10 year follow-up of an original randomized clinical trial (RCT) study (n= 114 patients) with type 1 and type 2 diabetes. The participants were referred to the department of Prosthetics & Orthotics (DPO) at Sahlgrenska University Hospital and were randomised to: 1) use prefabricated insoles, 2) soft custom-made insoles or 3) hard custom-made insoles. The groups were followed 2 years with follow-ups every 6 months. Data regarding plantar pressure, gait characteristics, kinetics and kinematics and presence of risk factors will be collected 10 years after inclusions. Comparisons will be made with a group of patients with diabetes being first times visitors to the Department of Prosthetics & Orthotics.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prefabricated insoles
Arm Type
Experimental
Arm Description
Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.
Arm Title
Custom-made insoles soft
Arm Type
Experimental
Arm Description
Custom-made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate.
Arm Title
Custom-made hard
Arm Type
Experimental
Arm Description
Custom-made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention with therapeutic insoles and/or shoes.
Intervention Type
Device
Intervention Name(s)
Prefabricated insoles
Intervention Description
The participants received prefabricated insoles
Intervention Type
Device
Intervention Name(s)
Soft custom-made insoles
Intervention Description
The participants received soft custom-made insoles
Intervention Type
Device
Intervention Name(s)
Hard custom-made insoles
Intervention Description
The participants received hard custom-made insoles
Primary Outcome Measure Information:
Title
Peak pressure
Description
To compare the differences of peak pressure (kPa) in the four groups.
Time Frame
through study completion, an average of 1 year
Title
Pressure time integral
Description
To compare the differences of pressure time integral (kPa*s) in the four groups.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Moment at ankle-knee-and hip joint
Description
To compare the differences of joint moment (Nm/kg) in the four groups.
Time Frame
through study completion, an average of 1 year
Title
Speed
Description
To compare the differences of speed (m/s) in the four groups.
Time Frame
through study completion, an average of 1 year
Title
Cadence
Description
To compare the differences of cadence (step/min) in the four groups.
Time Frame
through study completion, an average of 1 year
Title
Stance (percent of stand phase)
Description
To compare the differences of stance phase (%) in the four groups.
Time Frame
through study completion, an average of 1 year
Title
Range of foot-knee and hip angles (minimum to maximum)
Description
To compare the differences of maximum angle (degree) in the four groups
Time Frame
through study completion, an average of 1 year
Title
Walking distance of 5 minutes walking
Description
To compare the differences of 5 minutes walking(m) distance in the four groups
Time Frame
through study completion, an average of 1 year
Title
Distribution of risk grade ( the risk to develop diabetic foot ulcers 1-4(1=no risk, 4=presence of foot ulcers)
Description
To assess the distribution of risk grade (1-4) in the four groups
Time Frame
through study completion, an average of 1 year
Title
Relation of different types of insoles and risk factors to peak pressure
Description
To assess the influence of different types of insoles and risk factors on high peak pressure (kPa)
Time Frame
through study completion, an average of 1 year
Title
Relation of different types of insoles and risk factors to pressure time integral
Description
To assess the influence of different types of insoles and risk factors on pressure time integral (kPa*s)
Time Frame
through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Health related quality of life
Description
To assess the quality of life (SF-36 and EQ-5D-5L) in the different groups
Time Frame
through study completion, an average of 1 year
Title
Costs for the assistive devices
Description
Calculation of costs (SEK and USD) for the assistive devices
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Björn Stålgren, BSc
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Department of Prostetics & Orthotics
City
Gothenburg
State/Province
Region Västragötaland
ZIP/Postal Code
41285
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes
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