Diabetic FootNCT05383391
Diabetic Foot Self Care
An observational study of Diabetic Foot, run by Sohag University.
Trial summary
Aim of the study: Studying patients' knowledge, practice and barriers of foot self-care among diabetic patients attending Sohag University Hospital,. Objectives: 1. To determine patients' knowledge and practice of foot self-care among diabetic patients attending Sohag University Hospital. 2. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 1 Dec 2023
- Phase
- Observational
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Known cases of type 2 Diabetes Mellitusaging between 30 and 70 years old. Exclusioncriteria: Emergency ward patients andpatients who were not willing, were excluded from the study. Patients with toes orfoot amputation, Patients having activefoot ulcers , Patients with cognitive impairment.
Who may be able to join
- Known cases of type 2 Diabetes Mellitusaging between 30 and 70 years old.
Who cannot join
- Emergency ward patients andpatients who were not willing, were excluded from the study.
- Patients with toes orfoot amputation, Patients having activefoot ulcers , Patients with cognitive impairment.
About this study
Official title: Knowledge, Practice and Barriers of Foot Self-Care Among Diabetic Patients at Sohag University Hospital
Aim of the study:
Studying patients' knowledge, practice and barriers of foot self-care among diabetic patients attending Sohag University Hospital,.
Read more
Objectives:
- To determine patients' knowledge and practice of foot self-care among diabetic patients attending Sohag University Hospital.
- To detect barriers of diabetic foot self-care among diabetic patients attending Sohag University Hospital.
Patients and methods:
Place of the study (locality):
Sohag University Hospital at endocrine outpatient clinic .
Type of the study (Study design):
A cross-sectional, descriptive questionnaire based study was designed to evaluate knowledge and practice of diabetic patients regarding foot care.
Period of data collection . 6 months Questionnaires will be distributed among the diabetes mellitus patients in Sohag University Hospital to get the information about the knowledge of the disease among patients. The answer of the questions will be scored with "yes" "no" or I don't "know".
The questionnaire consists of four sections(8):
- Demographic section .
- Knowledge related questions regarding foot care .
- Practice related questions regarding practice of foot care .
- Barriers to foot self-care . Questionnaire contained 7 questions regarding knowledge of foot care and 12 questions regarding practice of foot care, which was approved and validated by the research committee of faculty of Pharmacy.
Read the detailed description
Diabetic foot problems are one of the most common chronic complications of diabetes that has a tremendous economic and social impact on individuals, families and on health system as a whole in developing and developed countries.( ) Diabetic foot problems can be prevented through well-coordinated foot care services. Patient education is an important and essential element of any health program for diabetic foot prevention and control. ( ) Diabetic foot problems as one important complication of DM constitute an increasing public health problem and are a leading cause of hospital admission, amputation and mortality in diabetic patients. ( ) Education is the key element in successful management of diabetes, as knowledge about diabetes enables patients to play an active role in effective diabetes self-management.Performing daily foot care routines enables diabetic patients to detect foot abnormalities and injuries earlier, hence reduce or even prevent the risk of foot ulceration effectively. ( ) Diabetic peripheral neuropathy (DPN) is the most common complication of type 2 diabetes mellitus requiring frequent referral for medical or surgical management. ( ) Neuropathy results in loss of sensation in gloves and stocking pattern, which leads to loss of protective sensation to noxious stimuli, such as trauma induced by micro trauma to the skin and bone or trauma caused by stepping on a sharp object or skin injury due to ill fitting shoes.
Moreover, due to modulation of neuro muscular junction the muscles get deprived of their innervations leading to muscle atrophy and foot deformities. Thus, pressures are gradually abnormally distributed on the plantar aspect of the feet, causing an increased forefoot pressure than the rear foot, thereby increasing the risk for ulceration. Initially the situation looks trivial, but the problem posed by DPN in its due course progresses to deep tissue destruction. ( ) The center for disease control and prevention (CDC) reported that complementary foot-care programs including risk assessment, self-foot-care education, metabolic control, and referral to specialists may decrease the risk of amputation by 45%-85%. ( )
- Conditions
- Diabetic Foot
- Keywords
- DPN:Diabetic peripheral neuropathy., CDC:The center for disease control and prevention .
- Medical subject headings
- Diabetic Foot
What is being measured
The primary outcome is the main question the study is designed to answer.
Studying patients' knowledge, practice and barriers of foot self-care among diabetic patients attending Sohag University Hospital
A cross-sectional, descriptive questionnaire based study was designed to evaluate knowledge and practice of diabetic patients regarding foot care.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayyada Elsayed Mohamed Hussien, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383391
- Sponsor's protocol ID
- Soh-Med-22-05-01
- Status last verified
- May 2022
- First submitted
- 16 May 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Papanas N, Maltezos E. The diabetic foot: a global threat and a huge challenge for Greece. Hippokratia. 2009 Oct;13(4):199-204.
PubMed 20011082
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge, Practice and Barriers of Foot Self-Care Among Diabetic Patients at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05383391
- Acronym / sponsor ID
- Soh-Med-22-05-01
- Conditions
- Diabetic Foot
- Keywords
- DPN:Diabetic peripheral neuropathy., CDC:The center for disease control and prevention .
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 20 May 2022 (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.
Aim of the study:
Studying patients' knowledge, practice and barriers of foot self-care among diabetic patients attending Sohag University Hospital,.
Objectives:
- To determine patients' knowledge and practice of foot self-care among diabetic patients attending Sohag University Hospital.
- To detect barriers of diabetic foot self-care among diabetic patients attending Sohag University Hospital.
Patients and methods:
Place of the study (locality):
Sohag University Hospital at endocrine outpatient clinic .
Type of the study (Study design):
A cross-sectional, descriptive questionnaire based study was designed to evaluate knowledge and practice of diabetic patients regarding foot care.
Period of data collection . 6 months Questionnaires will be distributed among the diabetes mellitus patients in Sohag University Hospital to get the information about the knowledge of the disease among patients. The answer of the questions will be scored with "yes" "no" or I don't "know".
The questionnaire consists of four sections(8):
- Demographic section .
- Knowledge related questions regarding foot care .
- Practice related questions regarding practice of foot care .
- Barriers to foot self-care . Questionnaire contained 7 questions regarding knowledge of foot care and 12 questions regarding practice of foot care, which was approved and validated by the research committee of faculty of Pharmacy.
Detailed description
Diabetic foot problems are one of the most common chronic complications of diabetes that has a tremendous economic and social impact on individuals, families and on health system as a whole in developing and developed countries.( ) Diabetic foot problems can be prevented through well-coordinated foot care services. Patient education is an important and essential element of any health program for diabetic foot prevention and control. ( ) Diabetic foot problems as one important complication of DM constitute an increasing public health problem and are a leading cause of hospital admission, amputation and mortality in diabetic patients. ( ) Education is the key element in successful management of diabetes, as knowledge about diabetes enables patients to play an active role in effective diabetes self-management.Performing daily foot care routines enables diabetic patients to detect foot abnormalities and injuries earlier, hence reduce or even prevent the risk of foot ulceration effectively. ( ) Diabetic peripheral neuropathy (DPN) is the most common complication of type 2 diabetes mellitus requiring frequent referral for medical or surgical management. ( ) Neuropathy results in loss of sensation in gloves and stocking pattern, which leads to loss of protective sensation to noxious stimuli, such as trauma induced by micro trauma to the skin and bone or trauma caused by stepping on a sharp object or skin injury due to ill fitting shoes.
Moreover, due to modulation of neuro muscular junction the muscles get deprived of their innervations leading to muscle atrophy and foot deformities. Thus, pressures are gradually abnormally distributed on the plantar aspect of the feet, causing an increased forefoot pressure than the rear foot, thereby increasing the risk for ulceration. Initially the situation looks trivial, but the problem posed by DPN in its due course progresses to deep tissue destruction. ( ) The center for disease control and prevention (CDC) reported that complementary foot-care programs including risk assessment, self-foot-care education, metabolic control, and referral to specialists may decrease the risk of amputation by 45%-85%. ( )
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Known cases of type 2 Diabetes Mellitusaging between 30 and 70 years old. Exclusioncriteria: Emergency ward patients andpatients who were not willing, were excluded from the study. Patients with toes orfoot amputation, Patients having activefoot ulcers , Patients with cognitive impairment.
Key inclusion criteria (1 listed)
- Known cases of type 2 Diabetes Mellitusaging between 30 and 70 years old.
Key exclusion criteria (2 listed)
- Emergency ward patients andpatients who were not willing, were excluded from the study.
- Patients with toes orfoot amputation, Patients having activefoot ulcers , Patients with cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Studying patients' knowledge, practice and barriers of foot self-care among diabetic patients attending Sohag University Hospital
Time frame: 6 months
A cross-sectional, descriptive questionnaire based study was designed to evaluate knowledge and practice of diabetic patients regarding foot care.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Background: PubMed 20011082Papanas N, Maltezos E. The diabetic foot: a global threat and a huge challenge for Greece. Hippokratia. 2009 Oct;13(4):199-204.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot, run by Sohag University.
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 2 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 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Studying patients' knowledge, practice and barriers of foot self-care among diabetic patients attending Sohag University Hospital (time frame: 6 months). 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 NCT05383391, which also lists 1 linked publication.
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 May 2022.