Diabetic FootNCT05904262
Peripheral Protective Sensation in Type 2 Diabetes Mellitus
An observational study of Diabetic Foot and Diabetic Neuropathies, run by Istanbul Kent University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to investigate the effect of sole sensation on peripheral muscle strength, functional capacity, balance and physical activity level in individuals with Type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot, Diabetic Neuropathies
- What is being tested?
- Foot Sole Sensation Evaluation
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2023to 25 Jul 2023
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who were followed up with the diagnosis of Diabetes Mellitus at the Internal Medicine Outpatient Clinic of the Eyup Additional Service Building of Bezmialem October Foundation University
Who may be able to join
- Being diagnosed with Type 2 Diabetes Mellitus for at least 1 year
- To be between the ages of 18-65
- HbA1c value between 6.5-11
- No cognitive/mental problems
- Being able to walk independently
- Being literate in Turkish
Who cannot join
- Lack of co-operation
- Patients with uncontrolled hypertension and uncontrolled arrhythmias
- Vertigo and various vestibular system disorders
- Those with severe neurological or severe respiratory diseases
- Patients who have undergone percutaneous transluminal coronary angiography or have a cardiac pacemaker
- Previous stroke, myocardial infarction
Show all 14Show fewer
- Patients with major musculoskeletal problems
- Chronic renal failure
- Chronic liver disease
- Patients with hip or knee replacement surgery in the last 5 years
- Patients with an injury involving the lower extremity in the last 6 months
- Those who are pregnant
- Those with haemolytic or renal anaemia
- Those who cannot read and write Turkish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Peripheral Protective Sensation on Peripheral Muscle Strength, Functional Capacity, Balance and Physical Activity Level in Patients With Type 2 Diabetes Mellitus
The aim of our study was to investigate the effect of sole sensation on peripheral muscle strength, functional capacity, balance and physical activity level in individuals with Type 2 Diabetes Mellitus.
Read the detailed description
Type II diabetes mellitus (DM) is a chronic disease characterised by insulin resistance, which is common all over the world, imposes an economic burden on the patient and his/her family because it requires continuous care and treatment, and may adversely affect the quality and duration of life of patients by leading to organ and function losses due to the complications it causes. Today, diabetes is an increasingly important health problem due to its incidence and the problems it causes. In DM, macrovascular and microvascular complications are observed with the disease. It may lead to development of foot deformities, biomechanical abnormalities and loss of protective sensation in the foot due to motor, sensory and autonomic neuropathy especially in the lower extremity. In the progressive process, loss of protective sensation may result in peripheral neuropathy. In the literature, loss of protective sensation is shown as the primary cause of peripheral neuropathy. In a study, it was found that light touch pressure, two-point discrimination and vibration senses on the soles of the feet of patients with diabetes mellitus decreased compared to healthy individuals. Diabetic foot is an important complication of diabetes which can be prevented with patient education and early treatment, although mortality, morbidity and treatment costs are quite high. This condition affects the individual's life in many aspects. When reseracher examine the literature, most of the studies on physical activity, functional capacity and quality of life in individuals with Type 2 DM with neuropathy examine the effect of neuropathy on these parameters. There is little literature examining the effect of protective sensory loss before the development of neuropathy. Researcher think that it is important to evaluate the sole sensation before the development of neuropathy in type 2 DM patients in order to determine the risk factors. Researcher also think that we will contribute to the literature by examining the relationship between the level of protective sensory loss and muscle strength, functional capacity, balance and physical activity level.
The study is planned to include 30 volunteer participants diagnosed with Type 2 Diabetes Mellitus. In this prospective study based on face-to-face interview method; body fat (%), skeletal muscle mass (%) (with Omron BF511 Body Composition Monitor), waist and hip circumference, lower extremity muscle strength (for quadriceps and biceps muscles) (with muscle hand held dynamometer), It is planned to measure upper extremity muscle strength (grip strength) (with hand grip dynamometer), functional capacity (with 6 Minute Walk Test), postural stability, stability limits and sensory integration of balance (with Biodex Balance System®). In addition, participants are expected to answer the questions of the International Physical Activity Questionnaire-Short Form (IPAQ) to evaluate their physical activity levels.
- Conditions
- Diabetic Foot, Diabetic Neuropathies
- Being tested
- Foot Sole Sensation Evaluation
- Keywords
- Diabetic Foot, Diabetic Neuropathies, Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetic Foot, Diabetic Neuropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Sole Sensation EvaluationOther
Type 2 Diabetes Mellitus. In this prospective study based on face-to-face interview method; body fat (%), skeletal muscle mass (%) (with Omron BF511 Body Composition Monitor), waist and hip circumference, lower extremity muscle strength (for quadriceps and biceps muscles) (with muscle hand held dynamometer), It is planned to measure upper extremity muscle strength (grip strength) (with hand grip dynamometer), functional capacity (with 6 Minute Walk Test), postural stability, stability limits and sensory integration of balance (with Biodex Balance System®). In addition, individuals are expected to answer the questions of the International Physical Activity Questionnaire-Short Form (IPAQ) to evaluate their physical activity levels.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetic patients | Type 2 Diabetes Mellitus. In this prospective study based on face-to-face interview method; body fat (%), skeletal muscle mass (%) (with Omron BF511 Body Composition Monitor), waist and hip circumference, lower extremity muscle strength (for quadriceps and biceps muscles) (with muscle hand held dynamometer), It is planned to measure upper extremity muscle strength (grip strength) (with hand grip dynamometer), functional capacity (with 6 Minute Walk Test), postural stability, stability limits and sensory integration of balance (with Biodex Balance System®). In addition, individuals are expected to answer the questions of the International Physical Activity Questionnaire-Short Form (IPAQ) to evaluate their physical activity levels. Receives: Other: Foot Sole Sensation Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Sole Sensation Evaluation
Light touch pressure sensation will be assessed with the 10-g monofilament -Semmes Weinstein test. A 128 Hz diapause will be used to test the sense of vibration. Firstly, the diaposon will be applied to the patient's wrist (it can be on the elbow or clavicle), so that the patient will know what to experience beforehand. The diapozone is placed on the bone on the dorsal side of the distal phalanx of the first toe of the foot.For two-point discrimination sensation, two-point discrimination distance measurement with an esthesiometer (Baseline® , White Plains, NY, USA) will be used
Measured: 20 minute
Secondary outcomes (7)
Body mass index
Digital, portable and non-invasive "Omron BF511 Body Composition Monitor (Omron Healthcare Co.,Ltd.; Japan)" will be used to measure Body mass index (kg/m2) of the participants.
Measured: 5 minute
Body Fat
Digital, portable and non-invasive "Omron BF511 Body Composition Monitor (Omron Healthcare Co.,Ltd.; Japan)" will be used to measure Body fat (%) of the participants.
Measured: 5 minute
Skeletal muscle mass
Digital, portable and non-invasive "Omron BF511 Body Composition Monitor (Omron Healthcare Co.,Ltd.; Japan)" will be used to measure skeletal mass (%) of the participants.
Measured: 5 minute
Resting metabolism
Digital, portable and non-invasive "Omron BF511 Body Composition Monitor (Omron Healthcare Co.,Ltd.; Japan)" will be used to measure resting metabolism (kcal) of the participants.
Measured: 5 minute
Balance
Postural stability, stability limits and sensory integration of balance will be evaluated with Biodex Balance System®. Biodex Balance System® is an equipment used to evaluate postural stability, stability limits and fall risk, and validity and reliability studies have been performed
Measured: 20 minute
International Physical Activity Questionnaire-Short Form (IPAQ)
The questionnaire includes questions about physical activity performed for at least 10 minutes in the last 7 days. In the questionnaire, it is determined how many days in the last week and how long each day was spent in heavy physical activity (VPA), moderate physical activity (MPA) and walking (W). In the last question, the time spent daily without moving is questioned.
Measured: 3 minute
Muscle strength
The muscle strength of M. Biceps Brachii and M. Quadriceps Femoris will be performed using an electronic hand dynamometer (Commander Muscle Tester; JTECH Medical, USA). The grip force will be performed from the dominant hand using a Jamar brand dynamometer from hydraulic measuring instruments. Data obtained will be recorded in kilograms/force (kg/N)
Measured: 15 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start6 Jun 2023
- Primary completion25 Jun 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Kent University
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University
- Responsible party
- Principal investigator, Melis Usul, Istanbul Kent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904262
- Sponsor's protocol ID
- IstanbulKentU-FTR-MU-01
- Status last verified
- Jul 2023
- First submitted
- 24 May 2023
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peripheral Protective Sensation on Peripheral Muscle Strength, Functional Capacity, Balance and Physical Activity Level in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05904262
- Acronym / sponsor ID
- IstanbulKentU-FTR-MU-01
- Conditions
- Diabetic Foot, Diabetic Neuropathies
- Keywords
- Diabetic Foot, Diabetic Neuropathies, Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul Kent UniversityUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 25 Jun 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 15 Jun 2023 (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.
The aim of our study was to investigate the effect of sole sensation on peripheral muscle strength, functional capacity, balance and physical activity level in individuals with Type 2 Diabetes Mellitus.
Detailed description
Type II diabetes mellitus (DM) is a chronic disease characterised by insulin resistance, which is common all over the world, imposes an economic burden on the patient and his/her family because it requires continuous care and treatment, and may adversely affect the quality and duration of life of patients by leading to organ and function losses due to the complications it causes. Today, diabetes is an increasingly important health problem due to its incidence and the problems it causes. In DM, macrovascular and microvascular complications are observed with the disease. It may lead to development of foot deformities, biomechanical abnormalities and loss of protective sensation in the foot due to motor, sensory and autonomic neuropathy especially in the lower extremity. In the progressive process, loss of protective sensation may result in peripheral neuropathy. In the literature, loss of protective sensation is shown as the primary cause of peripheral neuropathy. In a study, it was found that light touch pressure, two-point discrimination and vibration senses on the soles of the feet of patients with diabetes mellitus decreased compared to healthy individuals. Diabetic foot is an important complication of diabetes which can be prevented with patient education and early treatment, although mortality, morbidity and treatment costs are quite high. This condition affects the individual's life in many aspects. When reseracher examine the literature, most of the studies on physical activity, functional capacity and quality of life in individuals with Type 2 DM with neuropathy examine the effect of neuropathy on these parameters. There is little literature examining the effect of protective sensory loss before the development of neuropathy. Researcher think that it is important to evaluate the sole sensation before the development of neuropathy in type 2 DM patients in order to determine the risk factors. Researcher also think that we will contribute to the literature by examining the relationship between the level of protective sensory loss and muscle strength, functional capacity, balance and physical activity level.
The study is planned to include 30 volunteer participants diagnosed with Type 2 Diabetes Mellitus. In this prospective study based on face-to-face interview method; body fat (%), skeletal muscle mass (%) (with Omron BF511 Body Composition Monitor), waist and hip circumference, lower extremity muscle strength (for quadriceps and biceps muscles) (with muscle hand held dynamometer), It is planned to measure upper extremity muscle strength (grip strength) (with hand grip dynamometer), functional capacity (with 6 Minute Walk Test), postural stability, stability limits and sensory integration of balance (with Biodex Balance System®). In addition, participants are expected to answer the questions of the International Physical Activity Questionnaire-Short Form (IPAQ) to evaluate their physical activity levels.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetic patients | – | Other: Foot Sole Sensation EvaluationType 2 Diabetes Mellitus. In this prospective study based on face-to-face interview method; body fat (%), skeletal muscle mass (%) (with Omron BF511 Body Composition Monitor), waist and hip circumference, lower extremity muscle strength (for quadriceps and biceps muscles) (with muscle hand held dynamometer), It is planned to measure upper extremity muscle strength (grip strength) (with hand grip dynamometer), functional capacity (with 6 Minute Walk Test), postural stability, stability limits and sensory integration of balance (with Biodex Balance System®). In addition, individuals are expected to answer the questions of the International Physical Activity Questionnaire-Short Form (IPAQ) to evaluate their physical activity levels. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were followed up with the diagnosis of Diabetes Mellitus at the Internal Medicine Outpatient Clinic of the Eyup Additional Service Building of Bezmialem October Foundation University
Key inclusion criteria (6 listed)
- Being diagnosed with Type 2 Diabetes Mellitus for at least 1 year
- To be between the ages of 18-65
- HbA1c value between 6.5-11
- No cognitive/mental problems
- Being able to walk independently
Key exclusion criteria (14 listed)
- Lack of co-operation
- Patients with uncontrolled hypertension and uncontrolled arrhythmias
- Vertigo and various vestibular system disorders
- Those with severe neurological or severe respiratory diseases
- Patients who have undergone percutaneous transluminal coronary angiography or have a cardiac pacemaker
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 |
|---|---|---|
| Foot Sole Sensation EvaluationType 2 Diabetes Mellitus. In this prospective study based on face-to-face interview method; body fat (%), skeletal muscle mass (%) (with Omron BF511 Body Composition Monitor), waist and hip circumference, lower extremity muscle strength (for quadriceps and biceps muscles) (with muscle hand held dynamometer), It is planned to measure upper extremity muscle strength (grip strength) (with hand grip dynamometer), functional capacity (with 6 Minute Walk Test), postural stability, stability limits and sensory integration of balance (with Biodex Balance System®). In addition, individuals are expected to answer the questions of the International Physical Activity Questionnaire-Short Form (IPAQ) to evaluate their physical activity levels. | Other | Type 2 diabetic patients |
Primary outcome
Foot Sole Sensation Evaluation
Time frame: 20 minute
Light touch pressure sensation will be assessed with the 10-g monofilament -Semmes Weinstein test. A 128 Hz diapause will be used to test the sense of vibration. Firstly, the diaposon will be applied to the patient's wrist (it can be on the elbow or clavicle), so that the patient will know what to experience beforehand. The diapozone is placed on the bone on the dorsal side of the distal phalanx of the first toe of the foot.For two-point discrimination sensation, two-point discrimination distance measurement with an esthesiometer (Baseline® , White Plains, NY, USA) will be used
7 secondary outcomes
Body mass index
Time frame: 5 minute
Body Fat
Time frame: 5 minute
Skeletal muscle mass
Time frame: 5 minute
Resting metabolism
Time frame: 5 minute
Balance
Time frame: 20 minute
International Physical Activity Questionnaire-Short Form (IPAQ)
Time frame: 3 minute
Muscle strength
Time frame: 15 minute
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 27 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot and Diabetic Neuropathies, run by Istanbul Kent University at 1 site in Turkey (Türkiye).
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 14 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 27 Jul 2023. 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 Turkey (Türkiye). 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?
Foot Sole Sensation Evaluation (time frame: 20 minute). 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 27 Jul 2023.