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Foot Care Assessment and Relation to Diabetic Complications

Primary Purpose

Diabetic Foot

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
integrated foot care program
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Foot

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Paula RofaeelRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

moderate and high risk patient with integrated foot care program

moderate and high risk patient with conventional treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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)
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)

Secondary Outcome Measures

Full Information

First Posted
August 22, 2021
Last Updated
April 13, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05040009
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 Medical history. Therapeutic history: Antidiabetic drugs (type, duration), other medications for obesity, hypertension and dyslipidemia Complete physical examination. 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) 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
259 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
moderate and high risk patient with integrated foot care program
Arm Type
Active Comparator
Arm Description
Integrated foot care program will be applied to moderate and high-risk patients for diabetic foot with follow up after 6-12 months Regular foot care and examination by an adequately trained professional: - Structured education Adequate footwear Foot-related exercises and weight-bearing activity. Foot examination and screening every 4 months in moderate risk and 2 months in high-risk patient for diabetic foot. Instructions about foot self-management
Arm Title
moderate and high risk patient with conventional treatment
Arm Type
No Intervention
Arm Description
conventional treatment will be applied to moderate and high-risk patients for diabetic foot with follow up after 6-12 months.
Intervention Type
Behavioral
Intervention Name(s)
integrated foot care program
Intervention Description
Regular foot care and examination by an adequately trained professional: - 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: Foot ulcers and their consequences Preventative foot self-care behaviors Wearing adequately protective footwear Undergoing regular foot checks Practicing proper foot hygiene 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
Primary Outcome Measure Information:
Title
Integrated foot care program in moderate and high-risk patients for diabetic foot versus conventional treatment
Description
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
Title
Evaluation of knowledge and practice of diabetic foot using questionnaire developed by Hasnain and colleagues and the Nottingham Assessment of Functional Foot Care (NAFFC)
Description
knowledge and practice are assessed using questionnaire developed by Hasnain and colleagues and the Nottingham Assessment of Functional Foot Care (NAFFC)
Time Frame
baseline
Title
Screening for diabetic foot and diabetic complication in patients attending at Diabetic center
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
paula R. Sedky
Phone
+201061854979
Email
paularofa@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Lobna F. El Toony
Phone
+201005571004
Email
leltoni@yahoo.com
Facility Information:
Facility Name
Paula Rofaeel
City
Assiut
State/Province
Asyut
ZIP/Postal Code
088
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Rofaeel, Master
Phone
01061854979
Email
paularofa@gmail.com
First Name & Middle Initial & Last Name & Degree
Lobna F. El Toony, MD
Phone
01005571004
Email
leltoni@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
27108148
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.
Results Reference
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PubMed Identifier
18297261
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.
Results Reference
background
PubMed Identifier
11054895
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.
Results Reference
background
PubMed Identifier
19813683
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.
Results Reference
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Foot Care Assessment and Relation to Diabetic Complications

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