Prevention of Diabetic Foot Clinical Trial
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.
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