Biomarkers in diabetic foot

Not yet recruiting

• Conditions: Other specified diabetes mellituswith other specified complications,

• Registration Number: CTRI/2021/01/030653
• Lead Sponsor: Lady Hardinge Medical College

Brief Summary

Aim of the study is to evaluate the levels of plasma, procalcitonin and d-dimer in patients with diabetic foot ulcer and correlate the same with the grade of diabetic foot ulcer.

After ethics approval andregistration on CTRI, all patients in the age group of 18 to 65 years withdiabetic foot ulcer in Lady Hardinge Medical College and associatedhospitals shall be considered for inclusion. Written informed consent willbe taken from patients. Blood samples will be collected in all patients.Reports will be evaluated and analysed. All demographic data will be recordedin a predesigned form.

 Blood samples for serumbiomarkers Procalcitonin and D dimer will be collected from all patients takingall aseptic precautions. Procalcitonin will be processed by spectrophotometricmethod by fully automated analysers (Beckman series) by respective kit. D-dimerwill be processed by ELISA method (Enzyme linked immunosorbent assay). Allother relevant investigations will be done as per proforma.

Biomarkerswill be correlated with the different grades of Diabetic Foot Ulcer accordingto the Meggitt-Wagnersystem of classification. [20]

| | |

| --- | --- |

|Grade -0

Healed or pre-ulcerative wound

|Grade-1

Superficial ulcer without penetrating to deeper layers

|Grade-2

Deeper ulcer and reaches tendon, bone or joint capsule

|Grade-3

Deeper tissues are involved and there is abscess formation, osteomyelitis or tendinitis

|Grade -4

Limited Gangrene(part of the foot)

|Grade-5

Whole foot gangrene

 The reports ofserum biomarkers will be collected and correlated.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-01-20
• Study Start: 2021-01-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

All new patients of any sex with 18 to 65 years of age with type 2 diabetes mellitus with diabetic foot ulcer in Lady Hardinge Medical College and associated hospitals.

Exclusion Criteria

• 1. Any patient who has received any antibiotics in last seven days.
• 2. Patients with other known site of infection.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Levels of Biomarkers Procalcitonin and d-dimer among the patients of Diabetic Foot Ulcer	Baseline Levels at presentation

Secondary Outcome Measures

Name	Time	Method
Grade of Diabetic Foot Ulcer and it’s correlation with Levels of Biomarkers.	Baseline At presentation

Trial Locations

Locations (1)

Sucheta Kriplani Hospital; 🇮🇳 Central, DELHI, India

Sucheta Kriplani Hospital

🇮🇳Central, DELHI, India

Dr Anup Mohta

Principal investigator

9810478187

mohtaanup@gmail.com