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Role of Inflammatory markers in different grades of Diabetic Foot Ulcer

Role of Insulin like growth factor 1 (IGF-1), TNF alpha, Interleukin 6 and hs-CRP in different grades of Diabetic Foot Ulcer - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/07/055588
Enrollment
250
Registered
2023-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Control Intervention1: Case Control: A total of 125 diabetic foot ulcer patients (25 in each group) and 125 diabetic patients without foot ulcer of both sex admitted to surgery wards will be screened

Sponsors

Dr Shaheen B Shaikh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A total of 125 diabetic foot ulcer patients and 125 diabetic patients without foot ulcer (free from foot wounds and acute or chronic disease), admitted to surgery wards will be enrolled in the study. All wounds will be graded when they will get admitted to the hospital according to the Wagner classification system into five grades (grade I - grade V), the number of patients in each group will be 25.Foot ulcer was defined as a full-thickness skin defect that required >=14 days for healing. Cases and controls will be matched for age (±3 years), sex and duration of Diabetes.

Exclusion criteria

Exclusion criteria: Patients with inflammatory or infectious diseases, autoimmune and rheumatic diseases, cancer, hematological diseases, malignancy, Pregnancy ,lactation ,Chronic inflammatory disorders, severe renal or liver failure, recent venous thromboembolism ,as well as those who were under treatment with immunodeficiency drugs , will be excluded from study . Foot ulcers caused by other conditions such as arterial insufficiency, venous insufficiency, or trauma will be excluded

Design outcomes

Primary

MeasureTime frame
the study may provide new insights that could lead to better diagnosis, prevention, & treatment of this condition, ultimately improving the health outcomes & well-being of affected individuals.Timepoint: At Baseline, 4 weeks and 8 weeks

Secondary

MeasureTime frame
This study can also raise the possibility that inflammatory markers might provide an adjunctive method for early detection of risk for this disease & ultimately decreases the lower limb amputation & hence decreasing the mortality & morbidity of patients with DFU.Timepoint: At Baseline, 4 weeks & 8 weeks

Countries

India

Contacts

Public ContactDr Shaheen B Shaikh

Yenepoya Medical College Hospital

principalymc@yenepoya.edu.in9249436909

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026