| CTRI Number |
CTRI/2022/06/043593 [Registered on: 30/06/2022] Trial Registered Prospectively |
| Last Modified On: |
30/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of diabetic foot, its evaluation, non-surgical methods of assessment and surgical treatments |
|
Scientific Title of Study
|
Diabetic Foot: Evaluation, Non-surgical Assessment and Surgical Management |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vedanti Rajesh Patil |
| Designation |
Senior Resident |
| Affiliation |
D Y Patil Medical College, Hospital and Research Center |
| Address |
Department of Plastic and Reconstructive Surgery, D Y Patil Medical College and Hospital, Sector-5 Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9930430788 |
| Fax |
|
| Email |
vedanti.patil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhas Abhyankar |
| Designation |
Professor of Plastic Surgery |
| Affiliation |
D Y Patil Medical College, Hospital and Research Center |
| Address |
Department of Plastic and Reconstructive Surgery, D Y Patil Medical College and Hospital, Sector-5 Nerul, Navi Mumbai
Department of Plastic and Reconstructive Surgery, D Y Patil Medical College and Hospital, Sector-5 Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9869038283 |
| Fax |
|
| Email |
drsvabhyankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vedanti Rajesh Patil |
| Designation |
Senior Resident |
| Affiliation |
D Y Patil Medical College, Hospital and Research Center |
| Address |
Department of Plastic and Reconstructive Surgery, D Y Patil Medical College and Hospital, Sector-5 Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9930430788 |
| Fax |
|
| Email |
vedanti.patil@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
D Y Patil Medical College Hospital and Research Center |
| Address |
D Y Patil Medical College and Hospital, Sector-5 Nerul, Navi Mumbai, Maharashtra, India 400706 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Vedanti Rajesh Patil |
D Y Patil Medical College, Hospital and Research Centre |
Ayyappa Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai
Thane
MAHARASHTRA |
9930430788
vedanti.patil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), Padmashree Dr D Y Patil Medical College, Hospital and Research Center, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Diabetic patients with evidence of foot ulcer
2. Diabetic patients having symptoms of peripheral neuropathy
3. Diabetic patients having symptoms of peripherial arterial disease
4. Diabetic patients with past history of foot ulcers or lower limb amputation
|
|
| ExclusionCriteria |
| Details |
1. Patients below age of 18 years
2. Patients with systemic inflammatory response syndrome
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study the clinical features of diabetic foot |
on presentation,
during treatment,
after treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate peripheral neuropathy in diabetic foot |
1. On presentation
2. During treatment
3. After treatment |
| Evaluate peripheral vascular disease in diabetic foot |
1. On presentation
2. during treatment
3. After treatment |
| Provide surgical management for diabetic foot |
On presentation
During treatment |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/06/2022 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
India has been called the diabetic capital of the world. Managing diabetic foot disease requires careful attention to properly diagnosing the condition and then determining what surgical interventions are required. Evaluation of diabetic foot disease includes risk factor identification, history and physical examination. Non-surgical assessment includes both subjective and objective measures of peripheral nerve functions like symptoms, signs, inspection, palpation, musculoskeletal examination, pain score by visual analogue scale, pin prick test, monofilament test, temperature perception test, vibration perception test, proprioception test, assessment of tone, power and deep tendon reflex, capillary refill time assessment, pedal pulses examination, vascular doppler study for ankle brachial index, toe brachial index, doppler waveform assessment and infrared thermometry. Surgical management includes various dressing methods, nerve decompression surgery, nerve transfer surgery, skin grafting and local flaps. Patients should be counselled regarding appropriate footwear and pressure garments. |