Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05383391
Other study ID # Soh-Med-22-05-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date December 1, 2023

Study information

Verified date May 2022
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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%. ( )


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date December 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

References & Publications (1)

Papanas N, Maltezos E. The diabetic foot: a global threat and a huge challenge for Greece. Hippokratia. 2009 Oct;13(4):199-204. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Studying patients' knowledge, practice and barriers of foot self-care among diabetic patients attending Sohag University Hospital A cross-sectional, descriptive questionnaire based study was designed to evaluate knowledge and practice of diabetic patients regarding foot care. 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT06154915 - Immune Cells in Diabetic Chronic Foot Ulcers
Completed NCT04624516 - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence N/A
Not yet recruiting NCT06278935 - Lifestyle Tailored Offloading for Diabetic Foot Ulcers N/A
Completed NCT02373592 - Implementation of Foot Thermometry and SMS and Voice Messaging to Prevent Diabetic Foot Ulcer N/A
Active, not recruiting NCT01903044 - Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating Phase 1/Phase 2
Completed NCT02092870 - Adipose Derived Regenerative Cellular Therapy of Chronic Wounds Phase 2
Completed NCT01212120 - The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections N/A
Completed NCT00402727 - Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection Phase 3
Recruiting NCT04085705 - The Prevalence of Contact Allergies for Wound Dressings In Patients With Diabetic Foot Ulcers (PAID Study)
Completed NCT04054804 - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting NCT04537676 - Patient Empowerment Study
Completed NCT04480801 - The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer N/A
Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A
Recruiting NCT05974592 - The Effect of Nurse-Led Diabetic Foot Self-Management Training Program N/A
Not yet recruiting NCT04630795 - ViscoTurf - Preventing Secondary Diabetic Foot Ulceration.
Not yet recruiting NCT05431660 - Diabetic Foot School and Biomechanics N/A
Completed NCT05101473 - Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study N/A
Completed NCT05123157 - Pattern and Type of Amputation and Mortality Rate Associated With Diabetic Foot in Jeddah, Saudi Arabia: A Retrospective Cohort Study
Enrolling by invitation NCT05043636 - Diabetic Neuropathy Screening Study 1.1 + Substudy 1.2-1.3-1.4
Completed NCT03254095 - Predictors of Skin Temperature, Plantar Pressure and Ulceration in Diabetic Foot Patients.