Diabetic Foot UlcersDFUsNCT07193992
Assessment of Non Vascular Risk Factors for Severity of Diabetic Foot Ulcers (DFUs)
An observational study of Diabetic Foot Ulcers and Diabetes Mellitus, run by Assiut University.
Trial summary
Diabetes mellitus is a chronic disease that occurs either when pancreas does not produce enough insulin or when the body can't use it effectively. Diabetes mellitus include : type 1(insulin deficiency) , type 2 ( insulin resistance ) , gestational diabetes, maturity onset diabetes of the young ( MODY) , neonatal DM … Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers, Diabetes Mellitus
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 30 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) with Type 1 or Type 2 diabetes mellitus diagnosed with diabetic foot ulcers, recruited from Assiut University Hospitals. Patients with peripheral vascular disease, non-diabetic foot ulcers, or severe comorbidities will be excluded .
Who may be able to join
- Confirmed diagnosis of type 1 or type 2 diabetes mellitus
- Age ≥ 18 years
- Presence of diabetic foot ulcers (DFUs)
- Hemodynamically stable
- Willing and able to provide written informed consent prior to enrollment.
Who cannot join
- Diabetes complicated by peripheral vascular disease
- Non-diabetic foot ulcers, including venous ulcers or pressure ulcers
- Severe comorbid conditions (e.g., terminal illness or severe cognitive impairment).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Shimaa EssamEldin Mohammed, Resident doctor at Assiut univ contact
About this study
Official title: Assessment of Non Vascular Risk Factors for Severity of Diabetic Foot Ulcers
Diabetes mellitus is a chronic disease that occurs either when pancreas does not produce enough insulin or when the body can't use it effectively. Diabetes mellitus include : type 1(insulin deficiency) , type 2 ( insulin resistance ) , gestational diabetes, maturity onset diabetes of the young ( MODY) , neonatal DM , wolfram syndrome, latent autoimmune diabetes in adults ( LADA ) , type 3 c diabetes, steroids - induced diabetes, cystic fibrosis disease ,Type 5 diabetes( Malnutrition related diabetes) which affect between 20-25 million primarily in Asia \& Africa. According to WHO the number of living people with diabetes rose from 200 million in 1990 to 830 million in 2022 . According to IDF : The latest atlas 2025 report that 11.1% or 1- 9 of adult population ( 20 - 79 ) is living with diabetes, which 4 in 10 unaware of their condition. One of the serious complications is Diabetic foot ulcers . The global prevalence of DFU is around 6.3 % while the annual incidence reported between9.1 to 26.1 million cases, that's mean that 1 in 16 of diabetic patients experiences a DFUs . DFUs can be defined as wound or ulceration on the foot of diabetic patients due to a combination of factors such as neuropathy, peripheral artery disease, trauma or pressure . DFUs can lead to serious complications up to death like infection, osteomyelitis, limb amputation that significantly impact a person's quality of life, causing pain, disability and psychological distress. Beyond that immediate impact on patients, but also affect their families, and the healthcare system so it's considered as an economic burden due to health care costs and lost productivity. So to solve the problem we should know what cause it first and so we can prevent it before happening, not just finding a solution and that will affect not just the patients and their families, but also the country. Non vascular risk factors significantly impact DFU severity and healing including neuropathy, infection, poor glycemic control, obesity , inadequate foot care, certain immunological and inflammatory responses , age , malnutrition, smoking, High BMI , repetitive stress and pressure, certain foot conditions like onychomycosis and even iron deficiency anemia have been linked to it .
Read the detailed description
Diabetes mellitus is a chronic disease that arises either from insufficient insulin production by the pancreas or from the body's inability to use insulin effectively. It encompasses a wide spectrum of subtypes, including type 1 diabetes (absolute insulin deficiency), type 2 diabetes (insulin resistance), gestational diabetes, maturity-onset diabetes of the young (MODY), neonatal diabetes, Wolfram syndrome, latent autoimmune diabetes in adults (LADA), type 3C diabetes, steroid-induced diabetes, cystic fibrosis-related diabetes, and malnutrition-related diabetes, which affects approximately 20-25 million people primarily in Asia and Africa . According to the World Health Organization (WHO), the global number of people living with diabetes increased dramatically from 200 million in 1990 to 830 million in 2022 . The latest International Diabetes Federation (IDF) Atlas (2025) reports that 11.1% of adults aged 20-79 years-equivalent to one in nine-are living with diabetes, with nearly 40% of them unaware of their condition .
One of the most serious and costly complications of diabetes is the diabetic foot ulcer (DFU). Globally, the prevalence of DFUs is estimated at around 6.3%, with an annual incidence ranging from 9.1 to 26.1 million cases . This implies that roughly one in sixteen people with diabetes will experience a foot ulcer during their lifetime. DFUs are defined as wounds or ulcerations on the feet of individuals with diabetes, typically resulting from a combination of neuropathy, peripheral artery disease, trauma, and increased plantar pressure . These ulcers may progress to severe complications, including deep infection, osteomyelitis, and lower-limb amputation, leading not only to pain, disability, and psychological distress, but also to increased mortality . Beyond their devastating impact on patients and their families, DFUs pose a significant economic burden on healthcare systems due to high treatment costs and loss of productivity .
To reduce this burden, a clear understanding of the underlying risk factors is critical-not only to treat but also to prevent DFUs. In addition to vascular impairment, non-vascular risk factors have been shown to play a central role in ulcer development, severity, and healing. These include peripheral neuropathy, poor glycemic control, obesity, malnutrition, smoking, repetitive stress and pressure, inadequate foot care, infections such as onychomycosis or tinea pedis, high body mass index, and systemic conditions such as iron-deficiency anemia . Recent studies further emphasized the role of hematologic and nutritional abnormalities (e.g., anemia, hypoalbuminemia , elevated inflammatory markers) as independent predictors of ulcer severity . A systematic assessment of these non-vascular contributors enables clinicians to identify patients at higher risk, tailor treatment strategies, and implement preventive measures at earlier stages. When combined with vascular evaluation, this approach provides a comprehensive risk profile, improves clinical outcomes, reduces the need for amputation. and ultimately enhances quality of life for individuals with diabetes .
- Conditions
- Diabetic Foot Ulcers, Diabetes Mellitus
- Keywords
- DFUs, Risk factors, Non vascular, Assessment, Diabetic foot ulcers, Amputation, Diabetes complications, Osteomyelitis, Glycemic control
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Diabetes Complications, Osteomyelitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer recurrence rate
Title: Ulcer recurrence rate Description: Proportion of patients experiencing recurrence of diabetic foot ulcer during the study period, confirmed by clinical examination.
Unit of Measure: Percentage of participants (%) Time Frame: 1 year
Measured: 1 year
Secondary outcomes (3)
1)Determine the modifiable non vascular risk factors . 2)Determine the severity & understanding the impact on healing , recurrence & outcomes.
Title: Wound size Description: Measurement of ulcer area (length × width) in cm² from baseline to study completion.
Unit of Measure: cm²
Title: Wound depth Description: Measurement of ulcer depth from the skin surface in centimeters. Unit of Measure: cm
Title: Wound site Description: Anatomical location of the ulcer classified as forefoot, midfoot, or hindfoot.
Unit of Measure: Site category
Title: Wound characteristics Description: Assessment of wound features including skin integrity, presence of necrotic tissue, slough or eschar, exudate, and clinical signs of infection.
Unit of Measure: Categorical assessment (presence/absence)
Title: Ulcer severity using SINBAD classification Description: Assessment of ulcer severity using the SINBAD scoring system (Site, Ischemia, Neuropathy, Bacterial Infection, Area, Depth).
Unit of Measure: Score (0-6).
Measured: 1 year
Ulcer recurrence rate
Description: Proportion of patients experiencing ulcer recurrence during the study period.
Unit of Measure: Percentage of participants (%)
Measured: 1 year
1) Determine the modifiable non vascular risk factors (2) Determine the severity & understanding the impact on healing , recurrence & outcomes
Primary Outcome Measure:
Title: Ulcer recurrence rate Description: Proportion of patients experiencing recurrence of diabetic foot ulcer during the study period, confirmed by clinical examination.
Unit of Measure: Percentage of participants (%)
Secondary Outcome Measures:
Title: Wound size Description: Measurement of ulcer area (length × width) in cm² from baseline to study completion.
Unit of Measure: cm² Unit of Measure: Site category Title: Wound characteristics Description: Assessment of wound features including loss of skin integrity, presence of necrotic tissue, slough or eschar, exudate or drainage, and clinical signs of infection.
Unit of Measure: Categorical assessment (presence/absence). Title: Ulcer severity using SINBAD classification Description: Assessment of ulcer severity using the SINBAD scoring system (Site, Ischemia, Neuropathy, Bacterial Infection, Area, Depth).
Unit of Measure: Score (0-6).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Essam Eldin Rshad Mohammed, Assiut University
- Investigators
- Mona Mohammed Soliman, Professor, Study chair, Assuit university - Endocrinology unit at internal medicine department.Hanaa Mohammed Riad Hussien, Lecturer, Study director, Assuit university - Endocrinology unit at internal medicine department.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193992
- Sponsor's protocol ID
- Diabetic foot ulcers
- Acronym
- DFUs
- Status last verified
- Sep 2025
- First submitted
- 30 Aug 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All the study information l will share with others for increasing the general knowledge about the disease and aiming for adding something.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Non Vascular Risk Factors for Severity of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07193992
- Acronym / sponsor ID
- DFUs / Diabetic foot ulcers
- Conditions
- Diabetic Foot Ulcers, Diabetes Mellitus
- Keywords
- DFUs, Risk factors, Non vascular, Assessment, Diabetic foot ulcers, Amputation, Diabetes complications, Osteomyelitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Sep 2025 (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.
Diabetes mellitus is a chronic disease that occurs either when pancreas does not produce enough insulin or when the body can't use it effectively. Diabetes mellitus include : type 1(insulin deficiency) , type 2 ( insulin resistance ) , gestational diabetes, maturity onset diabetes of the young ( MODY) , neonatal DM , wolfram syndrome, latent autoimmune diabetes in adults ( LADA ) , type 3 c diabetes, steroids - induced diabetes, cystic fibrosis disease ,Type 5 diabetes( Malnutrition related diabetes) which affect between 20-25 million primarily in Asia \& Africa. According to WHO the number of living people with diabetes rose from 200 million in 1990 to 830 million in 2022 . According to IDF : The latest atlas 2025 report that 11.1% or 1- 9 of adult population ( 20 - 79 ) is living with diabetes, which 4 in 10 unaware of their condition. One of the serious complications is Diabetic foot ulcers . The global prevalence of DFU is around 6.3 % while the annual incidence reported between9.1 to 26.1 million cases, that's mean that 1 in 16 of diabetic patients experiences a DFUs . DFUs can be defined as wound or ulceration on the foot of diabetic patients due to a combination of factors such as neuropathy, peripheral artery disease, trauma or pressure . DFUs can lead to serious complications up to death like infection, osteomyelitis, limb amputation that significantly impact a person's quality of life, causing pain, disability and psychological distress. Beyond that immediate impact on patients, but also affect their families, and the healthcare system so it's considered as an economic burden due to health care costs and lost productivity. So to solve the problem we should know what cause it first and so we can prevent it before happening, not just finding a solution and that will affect not just the patients and their families, but also the country. Non vascular risk factors significantly impact DFU severity and healing including neuropathy, infection, poor glycemic control, obesity , inadequate foot care, certain immunological and inflammatory responses , age , malnutrition, smoking, High BMI , repetitive stress and pressure, certain foot conditions like onychomycosis and even iron deficiency anemia have been linked to it .
Detailed description
Diabetes mellitus is a chronic disease that arises either from insufficient insulin production by the pancreas or from the body's inability to use insulin effectively. It encompasses a wide spectrum of subtypes, including type 1 diabetes (absolute insulin deficiency), type 2 diabetes (insulin resistance), gestational diabetes, maturity-onset diabetes of the young (MODY), neonatal diabetes, Wolfram syndrome, latent autoimmune diabetes in adults (LADA), type 3C diabetes, steroid-induced diabetes, cystic fibrosis-related diabetes, and malnutrition-related diabetes, which affects approximately 20-25 million people primarily in Asia and Africa . According to the World Health Organization (WHO), the global number of people living with diabetes increased dramatically from 200 million in 1990 to 830 million in 2022 . The latest International Diabetes Federation (IDF) Atlas (2025) reports that 11.1% of adults aged 20-79 years-equivalent to one in nine-are living with diabetes, with nearly 40% of them unaware of their condition .
One of the most serious and costly complications of diabetes is the diabetic foot ulcer (DFU). Globally, the prevalence of DFUs is estimated at around 6.3%, with an annual incidence ranging from 9.1 to 26.1 million cases . This implies that roughly one in sixteen people with diabetes will experience a foot ulcer during their lifetime. DFUs are defined as wounds or ulcerations on the feet of individuals with diabetes, typically resulting from a combination of neuropathy, peripheral artery disease, trauma, and increased plantar pressure . These ulcers may progress to severe complications, including deep infection, osteomyelitis, and lower-limb amputation, leading not only to pain, disability, and psychological distress, but also to increased mortality . Beyond their devastating impact on patients and their families, DFUs pose a significant economic burden on healthcare systems due to high treatment costs and loss of productivity .
To reduce this burden, a clear understanding of the underlying risk factors is critical-not only to treat but also to prevent DFUs. In addition to vascular impairment, non-vascular risk factors have been shown to play a central role in ulcer development, severity, and healing. These include peripheral neuropathy, poor glycemic control, obesity, malnutrition, smoking, repetitive stress and pressure, inadequate foot care, infections such as onychomycosis or tinea pedis, high body mass index, and systemic conditions such as iron-deficiency anemia . Recent studies further emphasized the role of hematologic and nutritional abnormalities (e.g., anemia, hypoalbuminemia , elevated inflammatory markers) as independent predictors of ulcer severity . A systematic assessment of these non-vascular contributors enables clinicians to identify patients at higher risk, tailor treatment strategies, and implement preventive measures at earlier stages. When combined with vascular evaluation, this approach provides a comprehensive risk profile, improves clinical outcomes, reduces the need for amputation. and ultimately enhances quality of life for individuals with diabetes .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) with Type 1 or Type 2 diabetes mellitus diagnosed with diabetic foot ulcers, recruited from Assiut University Hospitals. Patients with peripheral vascular disease, non-diabetic foot ulcers, or severe comorbidities will be excluded .
Key inclusion criteria (5 listed)
- Confirmed diagnosis of type 1 or type 2 diabetes mellitus
- Age ≥ 18 years
- Presence of diabetic foot ulcers (DFUs)
- Hemodynamically stable
- Willing and able to provide written informed consent prior to enrollment.
Key exclusion criteria (3 listed)
- Diabetes complicated by peripheral vascular disease
- Non-diabetic foot ulcers, including venous ulcers or pressure ulcers
- Severe comorbid conditions (e.g., terminal illness or severe 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
Ulcer recurrence rate
Time frame: 1 year
Title: Ulcer recurrence rate Description: Proportion of patients experiencing recurrence of diabetic foot ulcer during the study period, confirmed by clinical examination. Unit of Measure: Percentage of participants (%) Time Frame: 1 year
3 secondary outcomes
1)Determine the modifiable non vascular risk factors . 2)Determine the severity & understanding the impact on healing , recurrence & outcomes.
Time frame: 1 year
Ulcer recurrence rate
Time frame: 1 year
1) Determine the modifiable non vascular risk factors (2) Determine the severity & understanding the impact on healing , recurrence & outcomes
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: Undecided. All the study information l will share with others for increasing the general knowledge about the disease and aiming for adding something.
Related trials for Diabetic Foot Ulcers
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
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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.
Shimaa EssamEldin Mohammed, Resident doctor at Assiut univ contact
Mona Mohammed Soliman, Professor study chair
Assuit university - Endocrinology unit at internal medicine department.
Hanaa Mohammed Riad Hussien, Lecturer study director
Assuit university - Endocrinology unit at internal medicine department.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcers and Diabetes Mellitus, run by Assiut 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 26 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shimaa EssamEldin Mohammed, Resident doctor at Assiut univ (+20 01143723277, shaima.1728959@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer recurrence rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2025.