Musculoskeletal Changes After Physiotherapeutic Intervention in Podiatric Subjects (BIONEDIAN)

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.

Study Overview

• Status: Unknown
• Conditions: Prevention of Diabetic Foot
• Intervention / Treatment: Other: Physical intervention by exercise

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 14200
    • Recruiting
    • Institute for Clinical and Experimental Medicine
    • Contact: Eliška Vrátná, Mgr.; Phone Number: +420774549214; Email: vratnae@gmail.com
    • Contact: Vladimíra Fejfarová, MD, PhD; Phone Number: +420603877381; Email: vlfe@medicon.cz
    • Sub-Investigator: Jitka Hazdrová, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DF patient active; Patients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers	Other: Physical intervention by exercise; 12 week lasting exercise intervention
Active Comparator: DF patient control; Patients with Type 2 diabetes mellitus and diabetic foot, whose have healed diabetic foot ulcers	Other: Physical intervention by exercise; 12 week lasting exercise intervention
Experimental: Diabetic patient with mild neuropathy; Patients with Type 2 diabetes mellitus with mild form of peripheral sensory neuropathy	Other: Physical intervention by exercise; 12 week lasting exercise intervention
Experimental: Diabetic patient with severe neuropathy; Patients with Type 2 diabetes mellitus with severe form of peripheral sensory neuropathy	Other: Physical intervention by exercise; 12 week lasting exercise intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomechanics- plantar pressures	plantar pressures will be evaluated by pedobarograph (in Newtons)	changes after 12 weeks, 24 weeks
Biomechanics- biomechanics of the ankle	biomechanics of the ankle will be assessed by goniometry in angles	changes after 12 weeks, 24 weeks
Biomechanics- changes of foot joint angles	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	changes after 12 weeks, 24 weeks
Fitness - physical activity	The amount of physical activity will be assessed by IPAQ questioners	changes after 12 weeks, 24 weeks
Fitness - muscle strength	Muscle strength will be measured by dynamometry in Newtons	changes after 12 weeks, 24 weeks
Fitness - senior fitness	fitness will be assessed by seniorfittest containing 2 minutes step test (steps/2 min) and test of sitting (sits/30 seconds)	changes after 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ulceration/reulceration	detection of the incidence of ulceration/reulceration	changes after 12 weeks, 24 weeks
Psychosocial changes - quality of life	Quality of life will be evaluated by WHO-QoL Bref test (4 domains - high values mean bettr findings	changes after 12 weeks, 24 weeks
Psychosocial changes - depression	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	changes after 12 weeks, 24 weeks
Psychosocial changes - stress readaptation	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	changes after 12 weeks, 24 weeks
Metabolism - glucose control	Investigators will be loked for metabolic changes in diabetes control (HbA1c in mmol/mol, glycemia in mmol/l)	changes after 12 weeks, 24 weeks
Metabolism - lipid profile	The authors will control lipid profiles (Total-, HDL-, LDL-cholesterol in umol/l)	changes after 12 weeks, 24 weeks
Metabolism - myokines	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)	changes after 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: Mgr. Eliška Vrátná
• Collaborators: Vladimíra Fejfarová, MD, PhD; prof. Ing. Václav Bunc, CSc

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): March 30, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: December 15, 2019
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; prevention; diabetic foot; biomechanics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: 546417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Possible to look at the data in documentation site

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No