Assessment of Non Vascular Risk Factors for Severity of Diabetic Foot Ulcers (DFUs)

NCT07193992 | Not Yet Recruiting DMC

• 1 other identifier: Diabetic foot ulcers
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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 , 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 .

Conditions

Diabetic Foot Ulcers; Diabetes Mellitus

Keywords

DFUs; Risk factors; Non vascular; Assessment; Diabetic foot ulcers; Amputation; Diabetes complications; Osteomyelitis; Glycemic control

Outcome Measures

Primary Outcomes (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

  1 year

Secondary Outcomes (3)

• 1)Determine the modifiable non vascular risk factors . 2)Determine the severity & understanding the impact on healing , recurrence & outcomes.

  1 year

• Ulcer recurrence rate

  1 year

• 1) Determine the modifiable non vascular risk factors (2) Determine the severity & understanding the impact on healing , recurrence & outcomes

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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 .

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Diabetes Complications; Osteomyelitis

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Mona Mohammed Soliman, Professor

  Assuit university - Endocrinology unit at internal medicine department.

  STUDY CHAIR

• Hanaa Mohammed Riad Hussien, Lecturer

  Assuit university - Endocrinology unit at internal medicine department.

  STUDY DIRECTOR

Central Study Contacts

Shimaa EssamEldin Mohammed, Resident doctor at Assiut univ

CONTACT

+20 01143723277; shaima.1728959@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Internal Medicine, Assiut University .

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 26, 2025
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09