Musculoskeletal Changes After Physiotherapeutic Intervention in Podiatric Subjects (BIONEDIAN)

Mgr. Eliška Vrátná

Status: Unknown

Conditions: Prevention of Diabetic Foot

Treatments: Other: Physical intervention by exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04257409

546417

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups

DF patient active

Experimental group

Description:

Patients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers

Treatment:

Other: Physical intervention by exercise

DF patient control

Active Comparator group

Description:

Patients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers

Treatment:

Other: Physical intervention by exercise

Diabetic patient with mild neuropathy

Experimental group

Description:

Patients with Type 2 diabetes mellitus with mild form of peripheral sensory neuropathy

Treatment:

Other: Physical intervention by exercise

Diabetic patient with severe neuropathy

Experimental group

Description:

Patients with Type 2 diabetes mellitus with severe form of peripheral sensory neuropathy

Treatment:

Other: Physical intervention by exercise