Prevention of Diabetic Foot
Conditions
Keywords
diabetic foot, biomechanics, quality of life, prevention
Brief 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 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.
Interventions
OTHERPhysical intervention by exercise
12 week lasting exercise intervention
Sponsors
Vladimíra Fejfarová, MD, PhD
prof. Ing. Václav Bunc, CSc
Mgr. Eliška Vrátná
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
randomization of diabetic patients with healed diabetic foot according the randomization scheme
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* impossibility to exercise * amaurosis * non-compliance * critical limb ischemia * active ulcer, surgical wound * active Charcot foot * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomechanics- plantar pressures | changes after 12 weeks, 24 weeks | plantar pressures will be evaluated by pedobarograph (in Newtons) |
| Biomechanics- biomechanics of the ankle | changes after 12 weeks, 24 weeks | biomechanics of the ankle will be assessed by goniometry in angles |
| Biomechanics- changes of foot joint angles | 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 | changes after 12 weeks, 24 weeks | The amount of physical activity will be assessed by IPAQ questioners |
| Fitness - muscle strength | changes after 12 weeks, 24 weeks | Muscle strength will be measured by dynamometry in Newtons |
| Fitness - senior fitness | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ulceration/reulceration | changes after 12 weeks, 24 weeks | detection of the incidence of ulceration/reulceration |
| Metabolism - myokines | changes after 12 weeks, 24 weeks | 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) |
| Psychosocial changes - quality of life | changes after 12 weeks, 24 weeks | Quality of life will be evaluated by WHO-QoL Bref test (4 domains - high values mean bettr findings |
| Psychosocial changes - depression | changes after 12 weeks, 24 weeks | 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 |
| Psychosocial changes - stress readaptation | changes after 12 weeks, 24 weeks | 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 |
| Metabolism - glucose control | changes after 12 weeks, 24 weeks | Investigators will be loked for metabolic changes in diabetes control (HbA1c in mmol/mol, glycemia in mmol/l) |
| Metabolism - lipid profile | changes after 12 weeks, 24 weeks | The authors will control lipid profiles (Total-, HDL-, LDL-cholesterol in umol/l) |
Countries
Czechia
Contacts
Primary ContactEliška Vrátná, Mgr.
Backup ContactVladimíra Fejfarová, MD, PhD
Outcome results
None listed