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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prefabricated insoles | Experimental | Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material. |
|
| Custom-made insoles soft | Experimental | Custom-made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate. |
|
| Custom-made hard | Experimental | Custom-made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate. |
|
| Control group | No Intervention | No intervention with therapeutic insoles and/or shoes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prefabricated insoles | Device | The participants received prefabricated insoles |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Moment at ankle-knee-and hip joint | To compare the differences of joint moment (Nm/kg) in the four groups. | through study completion, an average of 1 year |
| Speed | To compare the differences of speed (m/s) in the four groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life | To assess the quality of life (SF-36 and EQ-5D-5L) in the different groups | through study completion, an average of 1 year |
| Costs for the assistive devices | Calculation of costs (SEK and USD) for the assistive devices |
Inclusion Criteria:
Intervention groups:
Exclusion Criteria:
Control group
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Björn Stålgren, BSc | Sahlgrenska University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Prostetics & Orthotics | Gothenburg | Region Västragötaland | 41285 | Sweden |
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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.
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| Soft custom-made insoles |
| Device |
The participants received soft custom-made insoles |
|
| Hard custom-made insoles | Device | The participants received hard custom-made insoles |
|
| through study completion, an average of 1 year |
| Cadence | To compare the differences of cadence (step/min) in the four groups. | through study completion, an average of 1 year |
| Stance (percent of stand phase) | To compare the differences of stance phase (%) in the four groups. | through study completion, an average of 1 year |
| Range of foot-knee and hip angles (minimum to maximum) | To compare the differences of maximum angle (degree) in the four groups | through study completion, an average of 1 year |
| Walking distance of 5 minutes walking | To compare the differences of 5 minutes walking(m) distance in the four groups | through study completion, an average of 1 year |
| 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 | through study completion, an average of 1 year |
| 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) | through study completion, an average of 1 year |
| 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) | through study completion, an average of 1 year |
| through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| D016523 | Foot Ulcer |
| D020233 | Gait Disorders, Neurologic |
| D009443 | Neuritis |
| D005530 | Foot Deformities |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003929 | Diabetic Neuropathies |
| D005534 | Foot Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009140 | Musculoskeletal Diseases |
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