Diabetic FootNCT05431660
Diabetic Foot School and Biomechanics
A study testing education and exercise protocol about diabetic foot in people with Diabetic Foot, run by Ankara Yildirim Beyazıt University.
Trial summary
The primary aim of the study is to establish a diabetic foot school. The secondary aim is to compare the effects of the training given to diabetic foot patients within the scope of the diabetic foot school, on sensory, balance, lower extremity biomechanics and the effectiveness of these individuals on the knowledge… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- education and exercise protocol about diabetic foot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Jul 2024
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with diabetic foot between the ages of 40-70,
- Type 2 diabetes patients with neuropathic symptoms
- standard wound care protocol is applied (cleaning the wound with saline, covering it with gauze),
- sedentary who has not exercised regularly for six months,
- Able to walk at least 10 meters unaided,
- Volunteers
Who cannot join
- Ulcer that has progressed to Wagner grade 3,4 or 5,
- standardized mini mental state assessment scale score below 18 points,
- body mass index over 30,
- gestational diabetes mellitus,
- malignant tumor,
- neurological and exacerbated systemic disease,
Show all 9Show fewer
- Charcot neuroarthropathy,
- length difference in lower extremity, fracture, surgical operation and
- Individuals with previous training in diabetic foot and other treatments that may affect wound healing
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Diabetic Foot School on Sensory, Balance and Lower Extremity Biomechanics
The primary aim of the study is to establish a diabetic foot school. The secondary aim is to compare the effects of the training given to diabetic foot patients within the scope of the diabetic foot school, on sensory, balance, lower extremity biomechanics and the effectiveness of these individuals on the knowledge level of diabetic foot.
With the evaluations to be made, the effectiveness of the diabetic foot school program will be proven and it will contribute to the literature with objective and evidence-based results. For these reasons, the hypotheses on which the research is based were formed as follows;
Read more
H11 hypothesis: The diabetic foot school program applied in diabetic foot patients has an effect on foot biomechanical measurements and gait parameters.
Hypothesis H12: In diabetic foot patients, the diabetic foot school program has an effect on the sensation of individuals.
H13 hypothesis: In diabetic foot patients, the diabetic foot school program has an effect on the balance of individuals.
H14 hypothesis: In diabetic foot patients, the diabetic foot school program has an effect on the diabetic foot and self-care behaviors of individuals.
Read the detailed description
The study will be carried out in a special gait analysis center. To work; Volunteers, aged 40-70 years, diagnosed with diabetic foot and having type 2 diabetes mellitus with neuropathic symptoms will be included. Participants will be randomly divided into two groups before starting. Trainings will be given to the 1st group within the scope of diabetic foot school, and an exercise program aiming to increase the mobility and strength of the foot will be implemented through video calls twice a week, face-to-face once a week for 8 weeks. The 2nd group will be given a booklet covering this training and they will be followed up with video calls 1 day a week for 8 weeks. In diabetic foot school education, foot anatomy and functions, biomechanics, diabetic foot causes, epidemiology, causes of pain will be explained and treatment methods, ergonomic information, exercises to be done, sensory education, appropriate positions in daily life activities, risky situations, points to be considered and foot care. information will be given.
Before the research, individuals will be informed about the purpose and content of the study.
Ulcer advanced to Wagner grade 3,4 or 5, standardized mini mental state assessment scale score below 18 points, body mass index over 30, gestational diabetes, malignant tumor, neurological and exacerbated systemic disease, charcot neuroarthropathy, length difference in the lower extremity, fracture, surgical operation and Individuals who have received training on diabetic foot before and who have received other treatments that may affect wound healing will be excluded from the study.
All evaluations of both groups will be made by the same physiotherapist before and 8 weeks after the study. At the end of the study, individuals in the 2nd group will be included in the diabetic foot school training upon their wishes.
Within the scope of the study, information such as demographic information, smoking status, medical history, ulcer history, previous ulcer locations, if any, medications they use, walking aids/orthotics/diabetic shoes, existing foot deformities will be recorded and Plantar pressure senses; With Semmes-Weinstein monofilaments, Vibration sense; With 128 Hz tuning fork, Pain; with neuropathic pain questionnaire (DN4) and visual analog scale (VAS), lower extremity position sense (proprioception sense); Acumar dual digital inclinometer, Lower extremity muscle strengths (hip flexor, extensor, knee flexor, extensor and ankle plantar flexor and dorsi flexors) with HandHeld Dynamometer muscle dynamometer, Lower extremity strengths with 'Stair Climbing Test (MICT)', their balance; With the 'Get Up and Walk Test' and the 'Functional Reach Test', The time-distance characteristics of the gait will be evaluated by means of a motion-detecting wireless sensor, BTS-G (G Sensor, BTS Bioengineering S.p.A., Italy).
Plantar pressures during walking will be evaluated with Rsscan (v9 clinical 2mt plate advanced system) pedobarography.
Individuals' knowledge about diabetic foot will be evaluated face to face with diabetic foot knowledge scale, foot self-care behaviors, diabetic foot self-care questionnaire and foot care behavior scale.
- Conditions
- Diabetic Foot
- Being tested
- education and exercise protocol about diabetic foot, control group
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education and exercise protocol about diabetic footOther
In diabetic foot school education, foot anatomy and functions, biomechanics, diabetic foot causes, epidemiology, causes of pain will be explained and treatment methods, ergonomic information, exercises to be done, sensory education, appropriate positions in daily life activities, risky situations, points to be considered and foot care. information will be given.
control groupOther
diabetic foot school information booklet and weekly video conference meeting
| Study group | Role | What they receive |
|---|---|---|
| tele-rehabilitation group | Experimental | 1st group within the scope of diabetic foot school, and an exercise program aiming to increase the mobility and strength of the foot will be implemented through video calls twice a week, face-to-face once a week for 8 weeks. Receives: Other: education and exercise protocol about diabetic foot |
| face to face training group | Active comparator | The 2nd group will be given a booklet covering this training and they will be followed up with video calls 1 day a week for 8 weeks. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar pressure senses
With Semmes-Weinstein monofilaments, In order to understand the test, individuals will be placed on the patient bed with their feet bare in the supine position, and several different points on the soles of the feet will be touched with a thick filament, first with the eyes open and then with the eyes closed, and the individual will be asked to answer "yes" when they feel the filament touch. . With each filament, each test point on the sole of the foot will be held for 2 seconds by applying pressure 3 times at right angles until the filament bends, and when the individual knows 1 of these 3 touches correctly, the relevant filament thickness will be recorded as the light touch-pressure threshold value for that test point of the individual.
Measured: immediately after the intervention.
Secondary outcomes (1)
Vibration sense
It will be evaluated over the first metatarsal head and medial malleolus with a 128 Hz tuning fork. The test will be explained by positioning the individuals as in other tests, and the actual evaluations will begin after the individual expresses that he/she understands the test. The physiotherapist will sit on a chair at the foot of the patient and touch the fork to the test point in an upright position, immediately after hitting the tip of the tuning fork to the foot. In the meantime, the individual was asked to say "done" as soon as he did not feel the vibration by running the digital stopwatch. The stopwatch will be stopped when the individual says "done". Evaluation will be applied 3 times for each test point and the average of the time obtained from the three applications will be recorded as the individual's vibration sense score.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe 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
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bahar KÜLÜNKOĞLU, assc. prof., Study director, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431660
- Sponsor's protocol ID
- 2021-587/35
- Status last verified
- Aug 2022
- First submitted
- 25 May 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balak BK, Anaforoglu B. Effects of a Structured Education and Exercise Program on Spatiotemporal Gait Parameters and Plantar Pressure in Individuals with Diabetic Peripheral Neuropathy: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2026 Aug 5:S0003-9993(26)00859-2. doi: 10.1016/j.apmr.2026.07.029. Online ahead of print.
PubMed 42556632
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diabetic Foot School on Sensory, Balance and Lower Extremity Biomechanics
- ClinicalTrials.gov ID
- NCT05431660
- Acronym / sponsor ID
- 2021-587/35
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 24 Jun 2022 (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 primary aim of the study is to establish a diabetic foot school. The secondary aim is to compare the effects of the training given to diabetic foot patients within the scope of the diabetic foot school, on sensory, balance, lower extremity biomechanics and the effectiveness of these individuals on the knowledge level of diabetic foot.
With the evaluations to be made, the effectiveness of the diabetic foot school program will be proven and it will contribute to the literature with objective and evidence-based results. For these reasons, the hypotheses on which the research is based were formed as follows;
H11 hypothesis: The diabetic foot school program applied in diabetic foot patients has an effect on foot biomechanical measurements and gait parameters.
Hypothesis H12: In diabetic foot patients, the diabetic foot school program has an effect on the sensation of individuals.
H13 hypothesis: In diabetic foot patients, the diabetic foot school program has an effect on the balance of individuals.
H14 hypothesis: In diabetic foot patients, the diabetic foot school program has an effect on the diabetic foot and self-care behaviors of individuals.
Detailed description
The study will be carried out in a special gait analysis center. To work; Volunteers, aged 40-70 years, diagnosed with diabetic foot and having type 2 diabetes mellitus with neuropathic symptoms will be included. Participants will be randomly divided into two groups before starting. Trainings will be given to the 1st group within the scope of diabetic foot school, and an exercise program aiming to increase the mobility and strength of the foot will be implemented through video calls twice a week, face-to-face once a week for 8 weeks. The 2nd group will be given a booklet covering this training and they will be followed up with video calls 1 day a week for 8 weeks. In diabetic foot school education, foot anatomy and functions, biomechanics, diabetic foot causes, epidemiology, causes of pain will be explained and treatment methods, ergonomic information, exercises to be done, sensory education, appropriate positions in daily life activities, risky situations, points to be considered and foot care. information will be given.
Before the research, individuals will be informed about the purpose and content of the study.
Ulcer advanced to Wagner grade 3,4 or 5, standardized mini mental state assessment scale score below 18 points, body mass index over 30, gestational diabetes, malignant tumor, neurological and exacerbated systemic disease, charcot neuroarthropathy, length difference in the lower extremity, fracture, surgical operation and Individuals who have received training on diabetic foot before and who have received other treatments that may affect wound healing will be excluded from the study.
All evaluations of both groups will be made by the same physiotherapist before and 8 weeks after the study. At the end of the study, individuals in the 2nd group will be included in the diabetic foot school training upon their wishes.
Within the scope of the study, information such as demographic information, smoking status, medical history, ulcer history, previous ulcer locations, if any, medications they use, walking aids/orthotics/diabetic shoes, existing foot deformities will be recorded and Plantar pressure senses; With Semmes-Weinstein monofilaments, Vibration sense; With 128 Hz tuning fork, Pain; with neuropathic pain questionnaire (DN4) and visual analog scale (VAS), lower extremity position sense (proprioception sense); Acumar dual digital inclinometer, Lower extremity muscle strengths (hip flexor, extensor, knee flexor, extensor and ankle plantar flexor and dorsi flexors) with HandHeld Dynamometer muscle dynamometer, Lower extremity strengths with 'Stair Climbing Test (MICT)', their balance; With the 'Get Up and Walk Test' and the 'Functional Reach Test', The time-distance characteristics of the gait will be evaluated by means of a motion-detecting wireless sensor, BTS-G (G Sensor, BTS Bioengineering S.p.A., Italy).
Plantar pressures during walking will be evaluated with Rsscan (v9 clinical 2mt plate advanced system) pedobarography.
Individuals' knowledge about diabetic foot will be evaluated face to face with diabetic foot knowledge scale, foot self-care behaviors, diabetic foot self-care questionnaire and foot care behavior scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| tele-rehabilitation group | Experimental | Other: education and exercise protocol about diabetic foot1st group within the scope of diabetic foot school, and an exercise program aiming to increase the mobility and strength of the foot will be implemented through video calls twice a week, face-to-face once a week for 8 weeks. |
| face to face training group | Active comparator | Other: control groupThe 2nd group will be given a booklet covering this training and they will be followed up with video calls 1 day a week for 8 weeks. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with diabetic foot between the ages of 40-70,
- Type 2 diabetes patients with neuropathic symptoms
- standard wound care protocol is applied (cleaning the wound with saline, covering it with gauze),
- sedentary who has not exercised regularly for six months,
- Able to walk at least 10 meters unaided,
Key exclusion criteria (9 listed)
- Ulcer that has progressed to Wagner grade 3,4 or 5,
- standardized mini mental state assessment scale score below 18 points,
- body mass index over 30,
- gestational diabetes mellitus,
- malignant tumor,
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 |
|---|---|---|
| education and exercise protocol about diabetic footIn diabetic foot school education, foot anatomy and functions, biomechanics, diabetic foot causes, epidemiology, causes of pain will be explained and treatment methods, ergonomic information, exercises to be done, sensory education, appropriate positions in daily life activities, risky situations, points to be considered and foot care. information will be given. | Other | tele-rehabilitation group |
| control groupdiabetic foot school information booklet and weekly video conference meeting | Other | face to face training group |
Primary outcome
Plantar pressure senses
Time frame: immediately after the intervention.
With Semmes-Weinstein monofilaments, In order to understand the test, individuals will be placed on the patient bed with their feet bare in the supine position, and several different points on the soles of the feet will be touched with a thick filament, first with the eyes open and then with the eyes closed, and the individual will be asked to answer "yes" when they feel the filament touch. . With each filament, each test point on the sole of the foot will be held for 2 seconds by applying pressure 3 times at right angles until the filament bends, and when the individual knows 1 of these 3 touches correctly, the relevant filament thickness will be recorded as the light touch-pressure threshold value for that test point of the individual.
1 secondary outcome
Vibration sense
Time frame: immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Derived from this study: PubMed 42556632Balak BK, Anaforoglu B. Effects of a Structured Education and Exercise Program on Spatiotemporal Gait Parameters and Plantar Pressure in Individuals with Diabetic Peripheral Neuropathy: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2026 Aug 5:S0003-9993(26)00859-2. doi: 10.1016/j.apmr.2026.07.029. Online ahead of print.
- 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.
Bahar KÜLÜNKOĞLU, assc. prof. study director
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing education and exercise protocol about diabetic foot in people with Diabetic Foot, run by Ankara Yildirim Beyazıt University.
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 9 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: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Büşra KALKAN BALAK, MsC (+905530527122, busrakalkannn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plantar pressure senses (time frame: immediately after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05431660, which also lists 1 linked publication.
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 16 Aug 2022.