Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-28 @ 4:55 PM
Study NCT ID:
NCT07193992
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Non Vascular Risk Factors for Severity of Diabetic Foot Ulcers (DFUs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D010019', 'term': 'Osteomyelitis'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-08-30', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ulcer recurrence rate', 'timeFrame': '1 year', 'description': 'Title: Ulcer recurrence rate Description: Proportion of patients experiencing recurrence of diabetic foot ulcer during the study period, confirmed by clinical examination.\n\nUnit of Measure: Percentage of participants (%) Time Frame: 1 year'}], 'secondaryOutcomes': [{'measure': '1)Determine the modifiable non vascular risk factors . 2)Determine the severity & understanding the impact on healing , recurrence & outcomes.', 'timeFrame': '1 year', 'description': 'Title: Wound size Description: Measurement of ulcer area (length × width) in cm² from baseline to study completion.\n\nUnit of Measure: cm²\n\nTitle: Wound depth Description: Measurement of ulcer depth from the skin surface in centimeters. Unit of Measure: cm\n\nTitle: Wound site Description: Anatomical location of the ulcer classified as forefoot, midfoot, or hindfoot.\n\nUnit of Measure: Site category\n\nTitle: Wound characteristics Description: Assessment of wound features including skin integrity, presence of necrotic tissue, slough or eschar, exudate, and clinical signs of infection.\n\nUnit of Measure: Categorical assessment (presence/absence)\n\nTitle: Ulcer severity using SINBAD classification Description: Assessment of ulcer severity using the SINBAD scoring system (Site, Ischemia, Neuropathy, Bacterial Infection, Area, Depth).\n\nUnit of Measure: Score (0-6).'}, {'measure': 'Ulcer recurrence rate', 'timeFrame': '1 year', 'description': 'Description: Proportion of patients experiencing ulcer recurrence during the study period.\n\nUnit of Measure: Percentage of participants (%)'}, {'measure': '1) Determine the modifiable non vascular risk factors (2) Determine the severity & understanding the impact on healing , recurrence & outcomes', 'timeFrame': '1 year', 'description': 'Primary Outcome Measure:\n\nTitle: Ulcer recurrence rate Description: Proportion of patients experiencing recurrence of diabetic foot ulcer during the study period, confirmed by clinical examination.\n\nUnit of Measure: Percentage of participants (%)\n\nSecondary Outcome Measures:\n\nTitle: Wound size Description: Measurement of ulcer area (length × width) in cm² from baseline to study completion.\n\nUnit 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.\n\nUnit 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).\n\nUnit of Measure: Score (0-6).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DFUs', 'Risk factors', 'Non vascular', 'Assessment', 'Diabetic foot ulcers', 'Amputation', 'Diabetes complications', 'Osteomyelitis', 'Glycemic control'], 'conditions': ['Diabetic Foot Ulcers', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "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 .", 'detailedDescription': "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 .\n\nOne 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 .\n\nTo 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 ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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 .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of type 1 or type 2 diabetes mellitus\n* Age ≥ 18 years\n* Presence of diabetic foot ulcers (DFUs)\n* Hemodynamically stable\n* Willing and able to provide written informed consent prior to enrollment.\n\nExclusion Criteria:\n\n* Diabetes complicated by peripheral vascular disease\n* Non-diabetic foot ulcers, including venous ulcers or pressure ulcers\n* Severe comorbid conditions (e.g., terminal illness or severe cognitive impairment).'}, 'identificationModule': {'nctId': 'NCT07193992', 'acronym': 'DFUs', 'briefTitle': 'Assessment of Non Vascular Risk Factors for Severity of Diabetic Foot Ulcers (DFUs)', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of Non Vascular Risk Factors for Severity of Diabetic Foot Ulcers', 'orgStudyIdInfo': {'id': 'Diabetic foot ulcers'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shimaa EssamEldin Mohammed, Resident doctor at Assiut univ', 'role': 'CONTACT', 'email': 'shaima.1728959@med.aun.edu.eg', 'phone': '+20 01143723277'}], 'overallOfficials': [{'name': 'Mona Mohammed Soliman, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assuit university - Endocrinology unit at internal medicine department.'}, {'name': 'Hanaa Mohammed Riad Hussien, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assuit university - Endocrinology unit at internal medicine department.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'All the study information l will share with others for increasing the general knowledge about the disease and aiming for adding something.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Physician, Department of Internal Medicine, Assiut University .', 'investigatorFullName': 'Shimaa Essam Eldin Rshad Mohammed', 'investigatorAffiliation': 'Assiut University'}}}}