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

NCT04054076 | Completed

• 1 other identifier: SU-896191
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

orthotics; kinematics; kinetics

Outcome Measures

Primary Outcomes (2)

• Peak pressure

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

  through study completion, an average of 1 year

• Pressure time integral

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

  through study completion, an average of 1 year

Secondary Outcomes (9)

• Moment at ankle-knee-and hip joint

  through study completion, an average of 1 year

• Speed

  through study completion, an average of 1 year

• Cadence

  through study completion, an average of 1 year

• Stance (percent of stand phase)

  through study completion, an average of 1 year

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

  through study completion, an average of 1 year

Other Outcomes (2)

• Health related quality of life

  through study completion, an average of 1 year

• Costs for the assistive devices

  through study completion, an average of 1 year

Study Arms (4)

Prefabricated insoles

EXPERIMENTAL

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

Device: Prefabricated insoles

Custom-made insoles soft

EXPERIMENTAL

Custom-made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate.

Device: Soft custom-made insoles

Custom-made hard

EXPERIMENTAL

Custom-made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate.

Device: Hard custom-made insoles

Control group

NO INTERVENTION

No intervention with therapeutic insoles and/or shoes.

Interventions

Prefabricated insoles DEVICE

The participants received prefabricated insoles

Prefabricated insoles

Soft custom-made insoles DEVICE

The participants received soft custom-made insoles

Custom-made insoles soft

Hard custom-made insoles DEVICE

The participants received hard custom-made insoles

Custom-made hard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Presence of foot ulcers

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Department of Prostetics & Orthotics

Gothenburg, Region Västragötaland, 41285, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot; Foot Ulcer; Gait Disorders, Neurologic; Neuritis; Foot Deformities

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies; Foot Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Musculoskeletal Diseases

Study Officials

• Björn Stålgren, BSc

  Sahlgrenska University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 13, 2019
• Study Start: January 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)