Prevention of Diabetic FootBIONEDIANNCT04257409
Musculoskeletal Changes After Physiotherapeutic Intervention in Podiatric Subjects
A study testing Physical intervention by exercise in people with Prevention of Diabetic Foot, run by Mgr. Eliška Vrátná at 1 site in Czechia.
Trial summary
The recurrence of diabetic foot ulcers (DFU) is a key problem in podiatric care. It is very often given by biomechanical abnormalities frequently present in those patients. The aim of our randomized controlled study is to find possible changes as of plantar pressures as of biomechanics of the ankle and small joints in… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Prevention of Diabetic Foot
- What is being tested?
- Physical intervention by exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2019to 1 Jan 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- sensoric neuropathy (mild - based on VPV 15-30 V or EMG results, severe - based on VPT above 50 V or EMG results)
- diabetic foot with healed diabetic foot ulcers, inactive Charcot foot
Who cannot join
- impossibility to exercise
- amaurosis
- non-compliance
- critical limb ischemia
- active ulcer, surgical wound
- active Charcot foot
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- active carcinoma
- recent stroke (last 8 weeks)
- recent myocardial infarction (last 8 weeks)
- recent PTA, PCI, bypass (last 8 weeks)
- myopathy
- rheumatoid arthritis
- cox-, gonartrosis of 3rd -4th grade.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Institute for Clinical and Experimental Medicine
Prague, 14200
Eliška Vrátná, Mgr., +420774549214, vratnae@gmail.com
Vladimíra Fejfarová, MD, PhD, +420603877381, vlfe@medicon.cz
About this study
Official title: Musculoskeletal Changes Induced by Physiotherapeutic Intervention, and Their Impact on the Induction of Diabetic Foot Syndrome and Psychosocial Status in Type 2 Diabetes Mellitus
The recurrence of diabetic foot ulcers (DFU) is a key problem in podiatric care. It is very often given by biomechanical abnormalities frequently present in those patients. The aim of our randomized controlled study is to find possible changes as of plantar pressures as of biomechanics of the ankle and small joints in patients with type 2 diabetes mellitus with different degrees of neuropathy. During this project, investigators will examine the possible impact of 12-week lasting intervention program on the distribution of plantar pressures, joint mobility and muscle strength of lower limbs. The incidence of ulcerations / reulcerations and changes of psychosocial characteristics will be evaluated during the study period.
Approximately 60 patients with Type 2 diabetes mellitus will be included into the study. These patients will be randomized into 3 study groups - patients with type 2 DM with mild form of peripheral sensory neuropathy (20 subjects), patient with severe peripheral neuropathy (20 subjects) and those with diabetic foot syndrome, without active lesion (20 subjects). All patients will undergo 12 week lasting active intervention program consisting of recommendations by a physiotherapist focusing on the improvement of physical fitness, muscle strength and foot joint improvement. Control group will be consisted of 20 patients with healed diabetic foot.
The outcomes of this project will try to objectively verify in the randomized controlled trial the impact of exercise on lower limb biomechanics, mobility, self-sufficiency, quality of life in patients with type 2 diabetes mellitus at risk or already developed diabetic foot syndrome.
- Conditions
- Prevention of Diabetic Foot
- Being tested
- Physical intervention by exercise
- Keywords
- diabetic foot, biomechanics, quality of life, prevention
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical intervention by exerciseOther
12 week lasting exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| DF patient active | Experimental | Patients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers Receives: Other: Physical intervention by exercise |
| DF patient control | Active comparator | Patients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers Receives: Other: Physical intervention by exercise |
| Diabetic patient with mild neuropathy | Experimental | Patients with Type 2 diabetes mellitus with mild form of peripheral sensory neuropathy Receives: Other: Physical intervention by exercise |
| Diabetic patient with severe neuropathy | Experimental | Patients with Type 2 diabetes mellitus with severe form of peripheral sensory neuropathy Receives: Other: Physical intervention by exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomechanics- plantar pressures
plantar pressures will be evaluated by pedobarograph (in Newtons)
Measured: changes after 12 weeks, 24 weeks
Biomechanics- biomechanics of the ankle
biomechanics of the ankle will be assessed by goniometry in angles
Measured: changes after 12 weeks, 24 weeks
Biomechanics- changes of foot joint angles
changes of foot joint agles will be evaluated by measurement of X-Rays bones angles - calcaneal pitch, talar-1st metatarsal angle and lateral Talocalcaneal angle
Measured: changes after 12 weeks, 24 weeks
Fitness - physical activity
The amount of physical activity will be assessed by IPAQ questioners
Measured: changes after 12 weeks, 24 weeks
Fitness - muscle strength
Muscle strength will be measured by dynamometry in Newtons
Measured: changes after 12 weeks, 24 weeks
Fitness - senior fitness
fitness will be assessed by seniorfittest containing 2 minutes step test (steps/2 min) and test of sitting (sits/30 seconds)
Measured: changes after 12 weeks, 24 weeks
Secondary outcomes (7)
ulceration/reulceration
detection of the incidence of ulceration/reulceration
Measured: changes after 12 weeks, 24 weeks
Psychosocial changes - quality of life
Quality of life will be evaluated by WHO-QoL Bref test (4 domains - high values mean bettr findings
Measured: changes after 12 weeks, 24 weeks
Psychosocial changes - depression
Depression status will be asessed by Geriatric Depression Scale (GDS) scale - minimum 0, maximum 30 points (higher then 9 points- mild form of depression, higher then 20 - severe depression
Measured: changes after 12 weeks, 24 weeks
Psychosocial changes - stress readaptation
Adaptation to stress will be detected by Stress Readaption Scale (0-400 points) - points higher then 150 - higher risk of worse stress readaptation and therefore higher risk of somatisation
Measured: changes after 12 weeks, 24 weeks
Metabolism - glucose control
Investigators will be loked for metabolic changes in diabetes control (HbA1c in mmol/mol, glycemia in mmol/l)
Measured: changes after 12 weeks, 24 weeks
Metabolism - lipid profile
The authors will control lipid profiles (Total-, HDL-, LDL-cholesterol in umol/l)
Measured: changes after 12 weeks, 24 weeks
Metabolism - myokines
Patients will be checked for changes in selected cytokines nad myokines (IL-4,6,7,8,15 in pg/ml, myostatin in pg/ml, irisin in ng/ml, FGF-21 in pg/ml)
Measured: changes after 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Jan 2019
- Primary completion30 Mar 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 patients with Type 2 diabetes mellitus. These patients will be randomized into 3 study groups - patients with type 2 DM with mild form of peripheral sensory neuropathy (20 subjects), patient with severe peripheral neuropathy (20 subjects) and those with diabetic foot syndrome, without active lesion (20 subjects). All patients will undergo 12 week lasting active intervention program consisting of recommendations by a physiotherapist focusing on the improvement of physical fitness, muscle strength and foot joint improvement. Control group will be consisted of 20 patients with healed diabetic foot.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mgr. Eliška Vrátná
- Sponsor type
- University, hospital or other
- Collaborators
- Vladimíra Fejfarová, MD, PhD, prof. Ing. Václav Bunc, CSc
- Responsible party
- Sponsor-investigator, Mgr. Eliška Vrátná, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257409
- Sponsor's protocol ID
- 546417
- Acronym
- BIONEDIAN
- Status last verified
- Feb 2020
- First submitted
- 15 Dec 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Possible to look at the data in documentation site
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Changes Induced by Physiotherapeutic Intervention, and Their Impact on the Induction of Diabetic Foot Syndrome and Psychosocial Status in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04257409
- Acronym / sponsor ID
- BIONEDIAN / 546417
- Conditions
- Prevention of Diabetic Foot
- Keywords
- diabetic foot, biomechanics, quality of life, prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mgr. Eliška VrátnáUniversity, hospital or other
- Collaborators
- Vladimíra Fejfarová, MD, PhD, prof. Ing. Václav Bunc, CSc
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 6 Feb 2020 (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 recurrence of diabetic foot ulcers (DFU) is a key problem in podiatric care. It is very often given by biomechanical abnormalities frequently present in those patients. The aim of our randomized controlled study is to find possible changes as of plantar pressures as of biomechanics of the ankle and small joints in patients with type 2 diabetes mellitus with different degrees of neuropathy. During this project, investigators will examine the possible impact of 12-week lasting intervention program on the distribution of plantar pressures, joint mobility and muscle strength of lower limbs. The incidence of ulcerations / reulcerations and changes of psychosocial characteristics will be evaluated during the study period.
Approximately 60 patients with Type 2 diabetes mellitus will be included into the study. These patients will be randomized into 3 study groups - patients with type 2 DM with mild form of peripheral sensory neuropathy (20 subjects), patient with severe peripheral neuropathy (20 subjects) and those with diabetic foot syndrome, without active lesion (20 subjects). All patients will undergo 12 week lasting active intervention program consisting of recommendations by a physiotherapist focusing on the improvement of physical fitness, muscle strength and foot joint improvement. Control group will be consisted of 20 patients with healed diabetic foot.
The outcomes of this project will try to objectively verify in the randomized controlled trial the impact of exercise on lower limb biomechanics, mobility, self-sufficiency, quality of life in patients with type 2 diabetes mellitus at risk or already developed diabetic foot syndrome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 60 patients with Type 2 diabetes mellitus. These patients will be randomized into 3 study groups - patients with type 2 DM with mild form of peripheral sensory neuropathy (20 subjects), patient with severe peripheral neuropathy (20 subjects) and those with diabetic foot syndrome, without active lesion (20 subjects). All patients will undergo 12 week lasting active intervention program consisting of recommendations by a physiotherapist focusing on the improvement of physical fitness, muscle strength and foot joint improvement. Control group will be consisted of 20 patients with healed diabetic foot.
| Arm | Type | Receives |
|---|---|---|
| DF patient active | Experimental | Other: Physical intervention by exercisePatients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers |
| DF patient control | Active comparator | Other: Physical intervention by exercisePatients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers |
| Diabetic patient with mild neuropathy | Experimental | Other: Physical intervention by exercisePatients with Type 2 diabetes mellitus with mild form of peripheral sensory neuropathy |
| Diabetic patient with severe neuropathy | Experimental | Other: Physical intervention by exercisePatients with Type 2 diabetes mellitus with severe form of peripheral sensory neuropathy |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus
- sensoric neuropathy (mild - based on VPV 15-30 V or EMG results, severe - based on VPT above 50 V or EMG results)
- diabetic foot with healed diabetic foot ulcers, inactive Charcot foot
Key exclusion criteria (13 listed)
- impossibility to exercise
- amaurosis
- non-compliance
- critical limb ischemia
- active ulcer, surgical wound
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 |
|---|---|---|
| Physical intervention by exercise12 week lasting exercise intervention | Other | DF patient active, DF patient control, Diabetic patient with mild neuropathy, Diabetic patient with severe neuropathy |
Primary outcome
Biomechanics- plantar pressures
Time frame: changes after 12 weeks, 24 weeks
plantar pressures will be evaluated by pedobarograph (in Newtons)
Biomechanics- biomechanics of the ankle
Time frame: changes after 12 weeks, 24 weeks
biomechanics of the ankle will be assessed by goniometry in angles
Biomechanics- changes of foot joint angles
Time frame: changes after 12 weeks, 24 weeks
changes of foot joint agles will be evaluated by measurement of X-Rays bones angles - calcaneal pitch, talar-1st metatarsal angle and lateral Talocalcaneal angle
Fitness - physical activity
Time frame: changes after 12 weeks, 24 weeks
The amount of physical activity will be assessed by IPAQ questioners
Fitness - muscle strength
Time frame: changes after 12 weeks, 24 weeks
Muscle strength will be measured by dynamometry in Newtons
Fitness - senior fitness
Time frame: changes after 12 weeks, 24 weeks
fitness will be assessed by seniorfittest containing 2 minutes step test (steps/2 min) and test of sitting (sits/30 seconds)
7 secondary outcomes
ulceration/reulceration
Time frame: changes after 12 weeks, 24 weeks
Psychosocial changes - quality of life
Time frame: changes after 12 weeks, 24 weeks
Psychosocial changes - depression
Time frame: changes after 12 weeks, 24 weeks
Psychosocial changes - stress readaptation
Time frame: changes after 12 weeks, 24 weeks
Metabolism - glucose control
Time frame: changes after 12 weeks, 24 weeks
Metabolism - lipid profile
Time frame: changes after 12 weeks, 24 weeks
Metabolism - myokines
Time frame: changes after 12 weeks, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: Undecided. Possible to look at the data in documentation site
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Diabetes, Peripheral Neuropathy
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Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers
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Not yet recruiting
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Diabetic Foot Ulcers (DFUs)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical intervention by exercise in people with Prevention of Diabetic Foot, run by Mgr. Eliška Vrátná at 1 site in Czechia.
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 3 inclusion and 13 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 6 Feb 2020. 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 Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eliška Vrátná, Mgr. (+420774549214, vratnae@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomechanics- plantar pressures (time frame: changes after 12 weeks, 24 weeks). The study lists 6 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 6 Feb 2020.