Clinical trial NCT05040009: Foot Care Assessment and Relation to Diabetic Complications
Official title: Foot Care and Footwear Assessment in Diabetic Patients and Its Relation to Diabetic Complications.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Screening for diabetic foot in patients attending at Diabetic center at Assiut university and its relations to diabetic microvascular complications (nephropathy, neuropathy and retinopathy) and macrovascular complications (stroke , myocardial infarction and peripheral arterial diseases).

Footwear assessment in diabetic patient. Evaluation of integrated foot care program in moderate and high-risk patients for diabetic foot.

Evaluation of knowledge and practice of diabetic foot

Detailed description: The International Diabetes Federation (IDF) has identified Egypt as the ninth leading country in the world for the number of patients with T2D. The prevalence of T2D in Egypt was almost tripled over the last 2 decades. This sharp rise could be attributed to either an increased pattern of the traditional risk factors for T2D such as obesity and physical inactivity and change in eating pattern or other risk factors unique to Egypt .

Diabetic foot complications are the most common cause of non-traumatic lower extremity amputations in the industrialized world, may cause death or physical and psychical disability, has a great impact on quality of life, and represents a high cost for society ( .

The term diabetic foot encompasses any lesion in the feet: infection, ulcer, and destruction of deep tissues occurring as the result of diabetes and its complications .

The absence of symptoms in a person with diabetes does not exclude foot disease; they may have asymptomatic neuropathy, peripheral artery disease, pre-ulcerative signs, or even an ulcer.

Every diabetic patient will be subjected to

1. Medical history.
2. Therapeutic history: Antidiabetic drugs (type, duration), other medications for obesity, hypertension and dyslipidemia
3. Complete physical examination.
4. The following work up;

   * Knowledge questionnaire developed by Hasnain and colleagues and the Nottingham Assessment of Functional Foot Care (NAFFC) .
   * Screening for diabetic foot .
   * Fundus examination
   * ECG
   * The following investigations: Alb/cre ration, HBA1c, lipid profile, blood urea, serum creatinine
   * Abdominal ultrasound
   * Ankle brachial index (ABI)
5. Integrated foot care program will be applied to moderate and high-risk patients for diabetic foot with follow up after 6-12 months vs conventional education

Eligibility criteria: Inclusion Criteria:

Adult patient with diabetic mellitus

Exclusion Criteria:

Major amputation of lower limbs. End stage organ failure. Diabetic patient less than 18 years or more than 75. Pregnant diabetic women. Connective tissue disease

Primary outcomes:
measure: Integrated foot care program in moderate and high-risk patients for diabetic foot versus conventional treatment
timeFrame: 6 to 12 month
measure: Evaluation of knowledge and practice of diabetic foot using questionnaire developed by Hasnain and colleagues and the Nottingham Assessment of Functional Foot Care (NAFFC)
timeFrame: baseline
measure: Screening for diabetic foot and diabetic complication in patients attending at Diabetic center
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Paula Rofaeel
state: Asyut
Study officials:
References:
citation: Hegazi R, El-Gamal M, Abdel-Hady N, Hamdy O. Epidemiology of and Risk Factors for Type 2 Diabetes in Egypt. Ann Glob Health. 2015 Nov-Dec;81(6):814-20. doi: 10.1016/j.aogh.2015.12.011.
citation: Prompers L, Schaper N, Apelqvist J, Edmonds M, Jude E, Mauricio D, Uccioli L, Urbancic V, Bakker K, Holstein P, Jirkovska A, Piaggesi A, Ragnarson-Tennvall G, Reike H, Spraul M, Van Acker K, Van Baal J, Van Merode F, Ferreira I, Huijberts M. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia. 2008 May;51(5):747-55. doi: 10.1007/s00125-008-0940-0. Epub 2008 Feb 23.
citation: Apelqvist J, Bakker K, van Houtum WH, Nabuurs-Franssen MH, Schaper NC. International consensus and practical guidelines on the management and the prevention of the diabetic foot. International Working Group on the Diabetic Foot. Diabetes Metab Res Rev. 2000 Sep-Oct;16 Suppl 1:S84-92. doi: 10.1002/1520-7560(200009/10)16:1+3.0.co;2-s.
citation: Hasnain S, Sheikh NH. Knowledge and practices regarding foot care in diabetic patients visiting diabetic clinic in Jinnah Hospital, Lahore. J Pak Med Assoc. 2009 Oct;59(10):687-90.