DiabetesDiab10NCT04054076
10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes
A study testing Prefabricated insoles, Soft custom-made insoles and Hard custom-made insoles in people with Diabetes and Diabetic Foot, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetic Foot, Plantar Ulcer
- What is being tested?
- Prefabricated insoles, Soft custom-made insoles and Hard custom-made insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Prostetics & Orthotics
Gothenburg, Region Västragötaland, 41285
About this study
Official title: 10 Years Follow-up of Gait Characteristics, Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes
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.
Read the 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.
- Conditions
- Diabetes, Diabetic Foot, Plantar Ulcer, Neuropathy, Gait Disorder, Sensorimotor, Motor Neuropathy
- Being tested
- Prefabricated insoles, Soft custom-made insoles, Hard custom-made insoles
- Keywords
- orthotics, kinematics, kinetics
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot, Foot Ulcer, Gait Disorders, Neurologic, Neuritis, Foot Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prefabricated insolesDevice
The participants received prefabricated insoles
Soft custom-made insolesDevice
The participants received soft custom-made insoles
Hard custom-made insolesDevice
The participants received hard custom-made insoles
| Study group | Role | What they receive |
|---|---|---|
| Prefabricated insoles | Experimental | Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material. Receives: 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. Receives: 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. Receives: Device: Hard custom-made insoles |
| Control group | No intervention | No intervention with therapeutic insoles and/or shoes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak pressure
To compare the differences of peak pressure (kPa) in the four groups.
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (9)
Moment at ankle-knee-and hip joint
To compare the differences of joint moment (Nm/kg) in the four groups.
Measured: through study completion, an average of 1 year
Speed
To compare the differences of speed (m/s) in the four groups.
Measured: through study completion, an average of 1 year
Cadence
To compare the differences of cadence (step/min) in the four groups.
Measured: through study completion, an average of 1 year
Stance (percent of stand phase)
To compare the differences of stance phase (%) in the four groups.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Jan 2020
- Primary completion31 Jan 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulla Hellstrand Tang, Sahlgrenska University Hospital
- Investigators
- Björn Stålgren, BSc, Study director, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054076
- Sponsor's protocol ID
- SU-896191
- Acronym
- Diab10
- Status last verified
- May 2022
- First submitted
- 25 Jul 2019
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10 Years Follow-up of Gait Characteristics, Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes
- ClinicalTrials.gov ID
- NCT04054076
- Acronym / sponsor ID
- Diab10 / SU-896191
- Conditions
- Diabetes, Diabetic Foot, Plantar Ulcer, Neuropathy, Gait Disorder, Sensorimotor, Motor Neuropathy
- Keywords
- orthotics, kinematics, kinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prefabricated insoles | Experimental | Device: Prefabricated insolesPrefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material. |
| Custom-made insoles soft | Experimental | Device: Soft custom-made insolesCustom-made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate. |
| Custom-made hard | Experimental | Device: Hard custom-made insolesCustom-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prefabricated insolesThe participants received prefabricated insoles | Device | Prefabricated insoles |
| Soft custom-made insolesThe participants received soft custom-made insoles | Device | Custom-made insoles soft |
| Hard custom-made insolesThe participants received hard custom-made insoles | Device | Custom-made hard |
Primary outcome
Peak pressure
Time frame: through study completion, an average of 1 year
To compare the differences of peak pressure (kPa) in the four groups.
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.
9 secondary outcomes
Moment at ankle-knee-and hip joint
Time frame: through study completion, an average of 1 year
Speed
Time frame: through study completion, an average of 1 year
Cadence
Time frame: through study completion, an average of 1 year
Stance (percent of stand phase)
Time frame: through study completion, an average of 1 year
Range of foot-knee and hip angles (minimum to maximum)
Time frame: through study completion, an average of 1 year
Walking distance of 5 minutes walking
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)
Time frame: through study completion, an average of 1 year
Relation of different types of insoles and risk factors to peak pressure
Time frame: through study completion, an average of 1 year
Relation of different types of insoles and risk factors to pressure time integral
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Björn Stålgren, BSc study director
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prefabricated insoles, Soft custom-made insoles and Hard custom-made insoles in people with Diabetes and Diabetic Foot, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak pressure (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.