An interventional study of Prefabricated insoles and Soft custom-made insoles in Diabetes, Diabetic Foot and Plantar Ulcer, sponsored by Sahlgrenska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Prevention
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.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 224 is above the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.
Compared within Diabetic Foot, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria:
Intervention groups:
Exclusion Criteria:
Control group
Exclusion Criteria:
Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.
Device: Prefabricated insoles
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 insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate.
Device: Hard custom-made insoles
No intervention with therapeutic insoles and/or shoes.
The participants received prefabricated insoles
The participants received soft custom-made insoles
The participants received hard custom-made insoles
Peak pressure
To compare the differences of peak pressure (kPa) in the four groups.
Time frame: 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.
Time frame: through study completion, an average of 1 year
Moment at ankle-knee-and hip joint
To compare the differences of joint moment (Nm/kg) in the four groups.
Time frame: through study completion, an average of 1 year
Speed
To compare the differences of speed (m/s) in the four groups.
Time frame: through study completion, an average of 1 year
Cadence
To compare the differences of cadence (step/min) in the four groups.
Time frame: through study completion, an average of 1 year
Stance (percent of stand phase)
To compare the differences of stance phase (%) in the four groups.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: through study completion, an average of 1 year
Health related quality of life
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
Costs for the assistive devices
Calculation of costs (SEK and USD) for the assistive devices
Time frame: through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2020 to primary completion in Jan 2021, 12 months.
Of 240 non-industry interventional studies with no phase under Diabetic Foot, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 12 months is below that.
Counting every sponsor, half of 343 studies reached it within 22 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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