Clinical trial NCT04257409: Musculoskeletal Changes After Physiotherapeutic Intervention in Podiatric Subjects
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prevention of Diabetic Foot
Keywords: diabetic foot
biomechanics
quality of life
prevention
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Vladimíra Fejfarová, MD, PhD
name: prof. Ing. Václav Bunc, CSc
First posted: 2020-02-06
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Biomechanics- plantar pressures
timeFrame: changes after 12 weeks, 24 weeks
measure: Biomechanics- biomechanics of the ankle
timeFrame: changes after 12 weeks, 24 weeks
measure: Biomechanics- changes of foot joint angles
timeFrame: changes after 12 weeks, 24 weeks
measure: Fitness - physical activity
timeFrame: changes after 12 weeks, 24 weeks
measure: Fitness - muscle strength
timeFrame: changes after 12 weeks, 24 weeks
measure: Fitness - senior fitness
timeFrame: changes after 12 weeks, 24 weeks
Secondary outcomes:
measure: ulceration/reulceration
timeFrame: changes after 12 weeks, 24 weeks
measure: Psychosocial changes - quality of life
timeFrame: changes after 12 weeks, 24 weeks
measure: Psychosocial changes - depression
timeFrame: changes after 12 weeks, 24 weeks
measure: Psychosocial changes - stress readaptation
timeFrame: changes after 12 weeks, 24 weeks
measure: Metabolism - glucose control
timeFrame: changes after 12 weeks, 24 weeks
measure: Metabolism - lipid profile
timeFrame: changes after 12 weeks, 24 weeks
measure: Metabolism - myokines
timeFrame: changes after 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine
Study officials:
References: