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Status unknownNCT05040009Updated Apr 20, 2022

Foot Care Assessment and Relation to Diabetic Complications

An interventional study of integrated foot care program in Diabetic Foot, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-20.

Sponsored by Assiut University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
259
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the 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
02

Conditions studied

  • Diabetic Foot
03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's planned enrollment of 259 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Adult patient with diabetic mellitus

Exclusion criteria

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

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
259 participants (estimated)

Study arms

  • Active comparator
    moderate and high risk patient with integrated foot care program

    Integrated foot care program will be applied to moderate and high-risk patients for diabetic foot with follow up after 6-12 months 1. Regular foot care and examination by an adequately trained professional: - 2. Structured education 3. Adequate footwear 4. Foot-related exercises and weight-bearing activity. 5. Foot examination and screening every 4 months in moderate risk and 2 months in high-risk patient for diabetic foot. 6. Instructions about foot self-management

    Behavioral: integrated foot care program

  • No intervention
    moderate and high risk patient with conventional treatment

    conventional treatment will be applied to moderate and high-risk patients for diabetic foot with follow up after 6-12 months.

Interventions

  • Behavioralintegrated foot care program

    1. Regular foot care and examination by an adequately trained professional: - 2. Structured education: Educational modality will be provided to patients in a structured way. This will take many forms: one-to-one verbal education session last around 30 min motivational interviewing, video education, booklets, pictorial education via animated drawing or descriptive images structured foot care education consists of information on: 1. Foot ulcers and their consequences 2. Preventative foot self-care behaviors 3. Wearing adequately protective footwear 4. Undergoing regular foot checks 5. Practicing proper foot hygiene 6. Seeking professional help in a timely manner after identifying a foot problem 3-Adequate footwear 4-Foot-related exercises and weight-bearing activity 5-Foot examination and screening 6- Instructions about foot self-management

06

What researchers measure

Primary outcomes

  1. Integrated foot care program in moderate and high-risk patients for diabetic foot versus conventional treatment

    moderate and high risk patients for diabetic foot will undergo integrated program vs conventional treatment as regard ulcer healing and recurrence

    Time frame: 6 to 12 month

  2. Evaluation of knowledge and practice of diabetic foot using questionnaire developed by Hasnain and colleagues and the Nottingham Assessment of Functional Foot Care (NAFFC)

    knowledge and practice are assessed using questionnaire developed by Hasnain and colleagues and the Nottingham Assessment of Functional Foot Care (NAFFC)

    Time frame: baseline

  3. Screening for diabetic foot and diabetic complication in patients attending at Diabetic center

    Screening for diabetic foot in patients attending at Diabetic centre at Assiut university according to IWGDF guidelines Every diabetic patient will be subjected to Fundus examination ECG The following investigations: Alb/creatinine ratio, HBA1c, lipid profile, blood urea, serum creatinine Abdominal ultrasound Ankle brachial index (ABI)

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
  • Paula Rofaeel
    Assiut, Asyut 088, Egypt
    Recruiting
08

References and documents

Publications

  • 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. PubMed 27108148 ↗
  • 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. PubMed 18297261 ↗
  • 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. PubMed 11054895 ↗
  • 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. PubMed 19813683 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05040009
Lead sponsor
Assiut University
Responsible party
Paula Rofaeel Sedky (Assistant lecturer Faculty of Medicine, ِِAssiut University, Assiut University) — Principal investigator
First posted
Sep 10, 2021
Start date
Dec 1, 2021
Primary completion
Mar 2023 (estimated)
Completion
May 2023 (estimated)
Last update
Apr 20, 2022

Study contacts

paula R. Sedky
Contact
paularofa@aun.edu.eg
+201061854979
Lobna F. El Toony
Contact
leltoni@yahoo.com
+201005571004

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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