NCT05040009

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
259

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

August 22, 2021

Last Update Submit

April 13, 2022

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (3)

  • 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

    6 to 12 month

  • 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)

    baseline

  • 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)

    baseline

Study Arms (2)

moderate and high risk patient with integrated foot care program

ACTIVE COMPARATOR

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

moderate and high risk patient with conventional treatment

NO INTERVENTION

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

Interventions

integrated foot care programBEHAVIORAL

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

moderate and high risk patient with integrated foot care program

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient with diabetic mellitus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paula Rofaeel

Asyut, Asyut Governorate, 088, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27108148BACKGROUND

  • 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.

    PMID: 18297261BACKGROUND

  • 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.

    PMID: 11054895BACKGROUND

  • 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.

    PMID: 19813683BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Central Study Contacts

paula R. Sedky

CONTACT

+201061854979paularofa@aun.edu.eg

Lobna F. El Toony

CONTACT

+201005571004leltoni@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer Faculty of Medicine, ِِAssiut University

Study Record Dates

First Submitted

August 22, 2021

First Posted

September 10, 2021

Study Start

December 1, 2021

Primary Completion

March 1, 2023

Study Completion

May 1, 2023

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations

EG(1)