| CTRI Number |
CTRI/2021/08/035724 [Registered on: 17/08/2021] Trial Registered Prospectively |
| Last Modified On: |
09/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
a study of surgical offloading procedures in chronic non-healing diabetic foot ulcers in a tertiary care hospital in puducherry |
|
Scientific Title of Study
|
An interventional study of surgical offloading procedures in chronic non-healing diabetic foot ulcers in a tertiary care hospital in puducherry |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranav Prem |
| Designation |
Junior Resident |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of General Surgery
Sri Venkateshwaraa Medical College Hospital and Research Centre
Ariyur, Puducherry
Department of General Surgery
Sri Venkateshwaraa Medical College Hospital and Research Centre
Ariyur, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8870457262 |
| Fax |
|
| Email |
pranavprem2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Selvakumar |
| Designation |
Associate Professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of General Surgery
Sri Venkateshwaraa Medical College Hospital and Research Centre
Ariyur, Puducherry
Department of General Surgery
Sri Venkateshwaraa Medical College Hospital and Research Centre
Ariyur, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9994481131 |
| Fax |
|
| Email |
selvasurgeon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranav Prem |
| Designation |
Junior Resident |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Department of General Surgery
Sri Venkateshwaraa Medical College Hospital and Research Centre
Ariyur, Puducherry
Department of General Surgery
Sri Venkateshwaraa Medical College Hospital and Research Centre
Ariyur, Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8870457262 |
| Fax |
|
| Email |
pranavprem2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa Medical College Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur, Pondicherry - 605102 |
| 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 Pranav Prem |
General Surgery and Plastic Surgery OPD |
Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur, Pondicherry - 605102
Pondicherry
PONDICHERRY |
8870457262
pranavprem2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L896||Pressure ulcer of heel, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Surgical offloading procedure |
Percutaneous flexor tenotomy, mini invasive floating metatarsal osteotomy, sesamoidectomy, exostectomy, keller arthroplasty |
| Comparator Agent |
Wound healing |
Patients are followed up for a period of 8 weeks post operatively and wound healing is monitored periodically |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Toe ulcer, forefoot ulcer, midfoot ulcer, hindfoot ulcer
2)Non-healing ulcers
3)Fit for surgery and anaesthesia
4)Controlled blood sugar levels |
|
| ExclusionCriteria |
| Details |
1)Acute infective ulcer
2)Uncontrolled blood sugar levels
3)Associated peripheral vascular disease
4)Underlying cardiac, pulmonary or renal disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreased pressure in the concerned area and thereby ulcer healing and reduced recurrence |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decreased ulcer recurrence |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/08/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Each patient will be enrolled based on the inclusion and exclusion criteria. After getting written informed consent, a detailed history is ellicited and examination is done and all the details will be entered in a pre structured proforma. After performing routinr investigations and pre-operative pedobarogram, pre anaesthetic fitness is obtained and surgical offloading is done. Post operative pedobarogram is done and patient is followed up for a period of 6 months to estimate the healing rate and recurrence. |