Diabetic FootNCT05040009
Foot Care Assessment and Relation to Diabetic Complications
A study testing integrated foot care program in people with Diabetic Foot, run by Assiut University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- integrated foot care program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient with diabetic mellitus
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Paula Rofaeel
Asyut, Asyut Governorate, 088
Paula Rofaeel, Master, 01061854979, paularofa@gmail.com
Lobna F. El Toony, MD, 01005571004, leltoni@yahoo.com
About this study
Official title: Foot Care and Footwear Assessment in Diabetic Patients and Its Relation to Diabetic Complications.
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
- 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
- Conditions
- Diabetic Foot
- Being tested
- integrated foot care program
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated foot care programBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Dec 2021
- Primary completionMar 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 259 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Rofaeel Sedky, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040009
- Sponsor's protocol ID
- Foot care assessment in DM
- Status last verified
- Apr 2022
- First submitted
- 22 Aug 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 27108148Prompers 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 18297261Apelqvist 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 11054895Hasnain 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Care and Footwear Assessment in Diabetic Patients and Its Relation to Diabetic Complications.
- ClinicalTrials.gov ID
- NCT05040009
- Acronym / sponsor ID
- Foot care assessment in DM
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 259 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moderate and high risk patient with integrated foot care program | Active comparator | Behavioral: integrated foot care programIntegrated 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 |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient with diabetic mellitus
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| integrated foot care program1. 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 | Behavioural | moderate and high risk patient with integrated foot care program |
Primary outcome
Integrated foot care program in moderate and high-risk patients for diabetic foot versus conventional treatment
Time frame: 6 to 12 month
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)
Time frame: baseline
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
Time frame: baseline
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Background: PubMed 27108148Hegazi 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.
- Background: PubMed 18297261Prompers 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.
- Background: PubMed 11054895Apelqvist 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.
- Background: PubMed 19813683Hasnain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrated foot care program in people with Diabetic Foot, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact paula R. Sedky (+201061854979, paularofa@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrated foot care program in moderate and high-risk patients for diabetic foot versus conventional treatment (time frame: 6 to 12 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05040009, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.