| CTRI Number |
CTRI/2019/09/021227 [Registered on: 13/09/2019] Trial Registered Prospectively |
| Last Modified On: |
21/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
commonness of fungal infection in diabetic foot ulcer and its correlation with wound outcome in Udupi district |
|
Scientific Title of Study
|
Prevalence of fungal infection in diabetic foot ulcer and their association with patient characteristics in Udupi district |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Linu Alice John |
| Designation |
Student (2nd year MSc MLT) |
| Affiliation |
Manipal College of Health Professionals |
| Address |
Department MLT, MCHP, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9497426978 |
| Fax |
|
| Email |
linuajohn95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saleena Ummer |
| Designation |
Associate professor (senior scale) |
| Affiliation |
Manipal College of Health Professionals |
| Address |
Department MLT, MCHP, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9611873965 |
| Fax |
|
| Email |
saleena.ummer@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saleena Ummer |
| Designation |
Associate professor (senior scale) |
| Affiliation |
Manipal College of Health Professionals |
| Address |
Department MLT, MCHP, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9611873965 |
| Fax |
|
| Email |
saleena.ummer@manipal.edu |
|
|
Source of Monetary or Material Support
|
| 8 Diabetic foot clinic in Udupi district(CHC byndoor, CHC nitte,CHC kota, CHC shirva, CHC bharmavar, CHC hebri,CHC kundapura) Taluk hospital Udupi,
District hospital, Ajjarkad, Udupi |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Linu Alice John |
Udupi district |
7 diabetic foot clinics (CHC Shirva, CHC Byndoor, CHC Kota, CHC Brahmavar, CHC Hebri, CHC Nitte, CHC Kundapura), Taluk hospital Coondapura, Taluk hospital Karkala, District hospital Ajjarkad, Manipal college of Health Professionals Room No.417
Udupi
KARNATAKA |
9497426978
linuajohn95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R895||Abnormal microbiological findingsin specimens from other organs, systems and tissues, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult with 30 years of age or above
2.All patients with diabetic foot attending taluk hospital and district hospital
|
|
| ExclusionCriteria |
| Details |
a) Patients with diabetic foot without any infection or debridement (partially healed) will be excluded
b) Biological materials required (type - blood, tissue etc and quantity) : Wound swabs and/or debridement from the foot ulcer
c) Statistical methods : Data will be expressed as number and/or percentage. Analysis will be done using SPSS software. The association of fungal infection with wound severity will be studied using Chi-square test |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of patients with fungal infection in Diabetic Foot Ulcer, Various fungal species identified in Diabetic Foot Ulcer
|
During follow up of diabetic foot wound ulcer |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2019 |
| Date of Study Completion (India) |
15/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Diabetic foot ulcer is one of the most communal outstanding problems in diabetes mellitus. There is a high chance of mortality in diabetic foot ulcer (DFU) patients compared to non-ulcerated diabetic patients, regardless of age, type and duration of diabetes, treatment of diabetes, HbA1c, history of lower extremity amputation. During the followup to the hospital wound swabs and tissue samples will be collected from the ulcer. Examined by staining, cultured to media, incubated and observed by conventional method |