10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes
- Conditions
- Diabetic FootPlantar UlcerNeuropathyGait Disorder, SensorimotorFoot DeformitiesFoot UlcerDiabetesMotor Neuropathy
- Interventions
- Device: Soft custom-made insolesDevice: Prefabricated insolesDevice: Hard custom-made insoles
- Registration Number
- NCT04054076
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 224
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Custom-made insoles soft Soft custom-made insoles Custom-made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate. Prefabricated insoles Prefabricated insoles Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material. Custom-made hard Hard custom-made insoles Custom-made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate.
- Primary Outcome Measures
Name Time Method Peak pressure through study completion, an average of 1 year To compare the differences of peak pressure (kPa) in the four groups.
Pressure time integral 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
Name Time Method Speed through study completion, an average of 1 year To compare the differences of speed (m/s) in the four groups.
Moment at ankle-knee-and hip joint through study completion, an average of 1 year To compare the differences of joint moment (Nm/kg) in the four groups.
Range of foot-knee and hip angles (minimum to maximum) through study completion, an average of 1 year To compare the differences of maximum angle (degree) in the four groups
Cadence through study completion, an average of 1 year To compare the differences of cadence (step/min) in the four groups.
Stance (percent of stand phase) through study completion, an average of 1 year To compare the differences of stance phase (%) in the four groups.
Walking distance of 5 minutes walking through study completion, an average of 1 year 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) through study completion, an average of 1 year 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 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)
Relation of different types of insoles and risk factors to pressure time integral 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)
Trial Locations
- Locations (1)
Department of Prostetics & Orthotics
🇸🇪Gothenburg, Region Västragötaland, Sweden