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

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ClinicalTrials.gov Identifier: NCT04054076
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Ulla Hellstrand Tang, Sahlgrenska University Hospital, Sweden

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.


Condition or disease Intervention/treatment Phase
Diabetes Diabetic Foot Plantar Ulcer Neuropathy Gait Disorder, Sensorimotor Motor Neuropathy Foot Deformities Foot Ulcer Device: Prefabricated insoles Device: Soft custom-made insoles Device: Hard custom-made insoles Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: 10 Years Follow-up of Gait Characteristics, Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : December 2021

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054076


Contacts
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Contact: Ulla Hellstrand Tang, PhD 0046706397913 ulla.tang@vgregion.se
Contact: Roy Tranberg, PhD 0046313438118 roy.tranberg@gu.se

Locations
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Sweden
Department of Prostetics & Orthotics
Gothenburg, Region Västragötaland, Sweden, 41285
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Study Director: Björn Stålgren, BSc Sahlgrenska University Hospital, Sweden

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Responsible Party: Ulla Hellstrand Tang, Principal Investigator, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT04054076     History of Changes
Other Study ID Numbers: SU-896191
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ulla Hellstrand Tang, Sahlgrenska University Hospital, Sweden:
orthotics
kinematics
kinetics
Additional relevant MeSH terms:
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Foot Deformities
Foot Deformities, Congenital
Gait Disorders, Neurologic
Diabetic Foot
Foot Ulcer
Diabetes Mellitus
Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Nervous System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies
Foot Diseases
Congenital Abnormalities
Musculoskeletal Diseases
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Neurologic Manifestations
Signs and Symptoms