Clinical trial NCT05383391: Diabetic Foot Self Care
Official title: Knowledge, Practice and Barriers of Foot Self-Care Among Diabetic Patients at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Foot
Keywords: DPN:Diabetic peripheral neuropathy.
CDC:The center for disease control and prevention .
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Known cases of type 2 Diabetes Mellitusaging between 30 and 70 years old.

Exclusioncriteria:

Emergency ward patients andpatients who were not willing, were excluded from the study.

Patients with toes orfoot amputation, Patients having activefoot ulcers , Patients with cognitive impairment.

Brief summary: Aim of the study:

Studying patients' knowledge, practice and barriers of foot self-care among diabetic patients attending Sohag University Hospital,.

Objectives:

1. To determine patients' knowledge and practice of foot self-care among diabetic patients attending Sohag University Hospital.
2. To detect barriers of diabetic foot self-care among diabetic patients attending Sohag University Hospital.

Patients and methods:

Place of the study (locality):

Sohag University Hospital at endocrine outpatient clinic .

Type of the study (Study design):

A cross-sectional, descriptive questionnaire based study was designed to evaluate knowledge and practice of diabetic patients regarding foot care.

Period of data collection . 6 months Questionnaires will be distributed among the diabetes mellitus patients in Sohag University Hospital to get the information about the knowledge of the disease among patients. The answer of the questions will be scored with "yes" "no" or I don't "know".

The questionnaire consists of four sections(8):

1. Demographic section .
2. Knowledge related questions regarding foot care .
3. Practice related questions regarding practice of foot care .
4. Barriers to foot self-care . Questionnaire contained 7 questions regarding knowledge of foot care and 12 questions regarding practice of foot care, which was approved and validated by the research committee of faculty of Pharmacy.

Detailed description: Diabetic foot problems are one of the most common chronic complications of diabetes that has a tremendous economic and social impact on individuals, families and on health system as a whole in developing and developed countries.( ) Diabetic foot problems can be prevented through well-coordinated foot care services. Patient education is an important and essential element of any health program for diabetic foot prevention and control. ( ) Diabetic foot problems as one important complication of DM constitute an increasing public health problem and are a leading cause of hospital admission, amputation and mortality in diabetic patients. ( ) Education is the key element in successful management of diabetes, as knowledge about diabetes enables patients to play an active role in effective diabetes self-management.Performing daily foot care routines enables diabetic patients to detect foot abnormalities and injuries earlier, hence reduce or even prevent the risk of foot ulceration effectively. ( ) Diabetic peripheral neuropathy (DPN) is the most common complication of type 2 diabetes mellitus requiring frequent referral for medical or surgical management. ( ) Neuropathy results in loss of sensation in gloves and stocking pattern, which leads to loss of protective sensation to noxious stimuli, such as trauma induced by micro trauma to the skin and bone or trauma caused by stepping on a sharp object or skin injury due to ill fitting shoes.

Moreover, due to modulation of neuro muscular junction the muscles get deprived of their innervations leading to muscle atrophy and foot deformities. Thus, pressures are gradually abnormally distributed on the plantar aspect of the feet, causing an increased forefoot pressure than the rear foot, thereby increasing the risk for ulceration. Initially the situation looks trivial, but the problem posed by DPN in its due course progresses to deep tissue destruction. ( ) The center for disease control and prevention (CDC) reported that complementary foot-care programs including risk assessment, self-foot-care education, metabolic control, and referral to specialists may decrease the risk of amputation by 45%-85%. ( )

Eligibility criteria: Inclusion Criteria:

* Known cases of type 2 Diabetes Mellitusaging between 30 and 70 years old.

Exclusion Criteria:

* Emergency ward patients andpatients who were not willing, were excluded from the study.

Patients with toes orfoot amputation, Patients having activefoot ulcers , Patients with cognitive impairment.

Primary outcomes:
measure: Studying patients' knowledge, practice and barriers of foot self-care among diabetic patients attending Sohag University Hospital
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Papanas N, Maltezos E. The diabetic foot: a global threat and a huge challenge for Greece. Hippokratia. 2009 Oct;13(4):199-204.