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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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

+20 01143723277

shaima.1728959@med.aun.edu.eg

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 .

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.

  1. 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. 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

  2. Ulcer recurrence rate

    Description: Proportion of patients experiencing ulcer recurrence during the study period.

    Unit of Measure: Percentage of participants (%)

    Measured: 1 year

  3. 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.

  1. First posted26 Sep 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
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.

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.

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