Diabetic Foot School and Biomechanics

NCT05431660 | Unknown

• 1 other identifier: 2021-587/35
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aim of the study is to establish a diabetic foot school. The secondary aim is to compare the effects of the training given to diabetic foot patients within the scope of the diabetic foot school, on sensory, balance, lower extremity biomechanics and the effectiveness of these individuals on the knowledge level of diabetic foot. With the evaluations to be made, the effectiveness of the diabetic foot school program will be proven and it will contribute to the literature with objective and evidence-based results. For these reasons, the hypotheses on which the research is based were formed as follows; H11 hypothesis: The diabetic foot school program applied in diabetic foot patients has an effect on foot biomechanical measurements and gait parameters. Hypothesis H12: In diabetic foot patients, the diabetic foot school program has an effect on the sensation of individuals. H13 hypothesis: In diabetic foot patients, the diabetic foot school program has an effect on the balance of individuals. H14 hypothesis: In diabetic foot patients, the diabetic foot school program has an effect on the diabetic foot and self-care behaviors of individuals.

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

• Plantar pressure senses

  With Semmes-Weinstein monofilaments, In order to understand the test, individuals will be placed on the patient bed with their feet bare in the supine position, and several different points on the soles of the feet will be touched with a thick filament, first with the eyes open and then with the eyes closed, and the individual will be asked to answer "yes" when they feel the filament touch. . With each filament, each test point on the sole of the foot will be held for 2 seconds by applying pressure 3 times at right angles until the filament bends, and when the individual knows 1 of these 3 touches correctly, the relevant filament thickness will be recorded as the light touch-pressure threshold value for that test point of the individual.

  immediately after the intervention.

Secondary Outcomes (1)

• Vibration sense

  immediately after the intervention

Other Outcomes (12)

• Patient's Pain

  immediately after the intervention

• Patient's Pain

  immediately after the intervention

• lower extremity position sense (proprioception sense);

  immediately after the intervention

Study Arms (2)

tele-rehabilitation group

EXPERIMENTAL

1st group within the scope of diabetic foot school, and an exercise program aiming to increase the mobility and strength of the foot will be implemented through video calls twice a week, face-to-face once a week for 8 weeks.

Other: education and exercise protocol about diabetic foot

face to face training group

ACTIVE COMPARATOR

The 2nd group will be given a booklet covering this training and they will be followed up with video calls 1 day a week for 8 weeks.

Other: control group

Interventions

education and exercise protocol about diabetic foot OTHER

In diabetic foot school education, foot anatomy and functions, biomechanics, diabetic foot causes, epidemiology, causes of pain will be explained and treatment methods, ergonomic information, exercises to be done, sensory education, appropriate positions in daily life activities, risky situations, points to be considered and foot care. information will be given.

tele-rehabilitation group

control group OTHER

diabetic foot school information booklet and weekly video conference meeting

face to face training group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with diabetic foot between the ages of 40-70,
• Type 2 diabetes patients with neuropathic symptoms
• standard wound care protocol is applied (cleaning the wound with saline, covering it with gauze),
• sedentary who has not exercised regularly for six months,
• Able to walk at least 10 meters unaided,
• Volunteers

You may not qualify if:

• Ulcer that has progressed to Wagner grade 3,4 or 5,
• standardized mini mental state assessment scale score below 18 points,
• body mass index over 30,
• gestational diabetes mellitus,
• malignant tumor,
• neurological and exacerbated systemic disease,
• Charcot neuroarthropathy,
• length difference in lower extremity, fracture, surgical operation and
• Individuals with previous training in diabetic foot and other treatments that may affect wound healing

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

MeSH Terms

Conditions

Diabetic Foot

Interventions

Educational Status; Control Groups

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Bahar KÜLÜNKOĞLU, assc. prof.

  Ankara Yildirim Beyazıt University

  STUDY DIRECTOR

Central Study Contacts

Büşra KALKAN BALAK, MsC

CONTACT

+905530527122; busrakalkannn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The people participating in the study will not know in which group they are in the study, but since the physiotherapist who gives the training and gives the treatment is the only person, the study will continue as a single blind.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 24, 2022
• Study Start: September 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share