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Clinical Trials/NCT04257409
NCT04257409
Unknown
Not Applicable

Musculoskeletal Changes Induced by Physiotherapeutic Intervention, and Their Impact on the Induction of Diabetic Foot Syndrome and Psychosocial Status in Type 2 Diabetes Mellitus

Mgr. Eliška Vrátná1 site in 1 country80 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prevention of Diabetic Foot
Sponsor
Mgr. Eliška Vrátná
Enrollment
80
Locations
1
Primary Endpoint
Biomechanics- changes of foot joint angles
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
January 1, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mgr. Eliška Vrátná
Responsible Party
Sponsor Investigator
Principal Investigator

Mgr. Eliška Vrátná

Faculty of Physical Education and Sport

Charles University, Czech Republic

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)

Outcomes

Primary Outcomes

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

Biomechanics- plantar pressures

Time Frame: changes after 12 weeks, 24 weeks

plantar pressures will be evaluated by pedobarograph (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)

Biomechanics- biomechanics of the ankle

Time Frame: changes after 12 weeks, 24 weeks

biomechanics of the ankle will be assessed by goniometry in angles

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

Secondary Outcomes

  • Metabolism - glucose control(changes after 12 weeks, 24 weeks)
  • Metabolism - myokines(changes after 12 weeks, 24 weeks)
  • ulceration/reulceration(changes after 12 weeks, 24 weeks)
  • Psychosocial changes - quality of life(changes after 12 weeks, 24 weeks)
  • Psychosocial changes - depression(changes after 12 weeks, 24 weeks)
  • Metabolism - lipid profile(changes after 12 weeks, 24 weeks)
  • Psychosocial changes - stress readaptation(changes after 12 weeks, 24 weeks)

Study Sites (1)

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