| CTRI Number |
CTRI/2014/08/004883 [Registered on: 19/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
12/08/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of skin changes seen in Chronic Kidney Disease in patients with atleast 6 months of Renal disease including patients on Hemodialysis. |
|
Scientific Title of Study
|
CUTANEOUS MANIFESTATIONS IN CHRONIC RENAL DISEASE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dinah theresa |
| Designation |
pg resident |
| Affiliation |
father muller medical college |
| Address |
department of dermatology
father muller medical college hospital
kankanady
mangalore 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
dinahlevillard@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinath Kambil |
| Designation |
Guide (Asst Prof) |
| Affiliation |
Father Muller medical college |
| Address |
Department of Dermatology
Father Muller Medical College Hospital
Kankanady
Mangalore 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9886395249 |
| Fax |
|
| Email |
srinath76@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dinah theresa |
| Designation |
pg resident |
| Affiliation |
father muller medical college |
| Address |
department of dermatology
father muller medical college hospital
kankanady
mangalore 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
|
| Fax |
|
| Email |
dinahlevillard@yahoo.com |
|
|
Source of Monetary or Material Support
|
| dr dinah theresa levillard |
|
|
Primary Sponsor
|
| Name |
Dr Dinah Theresa Levillard |
| Address |
Dr.Dinah T L
PG resident
Department of Dermatology
Father Muller Medical College
kankanady
mangalore 575002 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Father Muller Medical College |
Kankanady,
Mangalore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dinah Theresa Levillard |
Dialysis unit, Nephrology opd, Dermatology opd, Father Muller Medical College Hospital |
Kankanady
Mangalore 575002
Dakshina Kannada
Dakshina Kannada
KARNATAKA |
9611678585
dinahlevillard@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients with known history of chronic kidney disease including patients on hemodialysis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with history of chronic renal disease
Both sexes of any age group.
Patients willing for the required investigation with a written informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients of known immunocompromised status.
Patients undergoing hemodialysis following renal transplant or those who had undergone peritoneal dialysis.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
percentage of people with cutaneous manifestations in chronic renal disease
% of skin disease with severity of renal illness |
31/01/2015 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| % of skin chnages seen in chronic renal disease and association with gfr |
1 year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is being carried out to document the skin changes seen in chronic renal disease of atleast 6months duration. The study also aims to check the occurence of skin changes along with severity of renal disease.
Early detection of skin changes associated with disease may help with the detection of the underlying condition itself, thereby helping in early treatment of the patient.
This study will be a prospective study including consecutive patients attending nephrology opd and hemodialysis unit of Father Muller medical college hospital. minimum sample size is 30 patients, of any age group and sex, with minimum of 6month history of renal disease. The study excludes those who have had renal transplant and peritoneal dialysis.
Data will be analysed to find the prevalence and types of skin changes in renal disease and distribution of skin changes in relation to the severity of renal disease |