| CTRI Number |
CTRI/2024/04/064964 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
geko Wound Registry for Diabetic Foot Ulcers |
|
Scientific Title of Study
|
geko™ Cross Therapy Registry – Wound. Post Market Clinical Follow-up of Safety and Patient Outcomes for Subjects Undergoing Peroneal Nerve Stimulation by geko™ |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| FSK-REG-002 - IN; Version 2.0; Date: 09 December 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Vaidya |
| Designation |
Hon. Consultant |
| Affiliation |
S.L. Rajeha (Fortis) Hospital (Mahim) |
| Address |
Department of Plastic surgery,
Division Diabetic Foot,
O. P. D. Room number 8
Mumbai
MAHARASHTRA
400016
India |
| Phone |
9820020088 |
| Fax |
|
| Email |
drsanjaymvaidya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Atul Khurana |
| Designation |
Country Manager, Firstkind Ltd |
| Affiliation |
Firstkind Ltd |
| Address |
Commercial Division,
Office 638, Gera Imperium Rise,
Hinjawadi Phase 2,
Pune
Pune
MAHARASHTRA
411057
India |
| Phone |
9811716891 |
| Fax |
|
| Email |
Atul.Khurana@firstkindmedical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Vaidya |
| Designation |
Hon. Consultant |
| Affiliation |
S.L. Rajeha (Fortis) Hospital (Mahim) |
| Address |
Department of Plastic surgery,
Division Diabetic Foot,
O. P. D. Room number 8
Mumbai
MAHARASHTRA
400016
India |
| Phone |
9820020088 |
| Fax |
|
| Email |
drsanjaymvaidya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Study Sponsor: Firstkind Ltd., Hawk House, Peregrine Business Park, Gomm Road, High Wycombe, Bucks, HP13 7DL, United Kingdom |
|
|
Primary Sponsor
|
| Name |
Firstkind Ltd |
| Address |
Hawk House
Peregrine Business Park
Gomm Road
High Wycombe
Bucks
UK
HP13 7DL |
| Type of Sponsor |
Other [Medical Device Industry - Global] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Vaidya |
S. L. Raheja Hospital |
Department of Plastic surgery,
Division Diabetic Foot,
O. P. D. Room number 8,
Raheja Marg,
Mahim,
Mumbai-400016 India
Mumbai
MAHARASHTRA |
009124325353
drsanjaymvaidya@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee S. L. Raheja Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I739||Peripheral vascular disease, unspecified, (2) ICD-10 Condition: E105||Type 1 diabetes mellitus with circulatory complications, (3) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, (4) ICD-10 Condition: I872||Venous insufficiency (chronic) (peripheral), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL - this is observational trial |
| Comparator Agent |
NIL |
NIL - this is observational trial |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Aged ≥ 18 years
2. Patients who are diagnosed with a diabetic foot ulcer
3. Intact healthy skin at the site of gekoâ„¢ device application.
4. Willing and able to give written informed consent
5. Identified to receive gekoâ„¢ therapy as part of their standard care for wound management. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy or breast feeding
2. Use of any other neuro-modulation device.
3. Current use of TENS in the pelvic region, back or legs
4. Trauma to the lower limbs that would prevent gekoâ„¢ from stimulating the common peroneal nerve.
5. No response to gekoâ„¢ therapy i.e., no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Frequency of adverse events
Obtain frequency of adverse events (AEs) & serious AEs (SAEs) whether device related or not & compare rate to historic and published data i.e., gekoâ„¢ therapy vs standard care without gekoâ„¢ therapy
2.Frequency of device deficiencies
Obtain frequency of Device Deficiencies (DD) and compare rate to historic and published data i.e., gekoâ„¢ therapy vs standard care without gekoâ„¢ therapy
3. Summary of routinely tested and collected performance data
Obtain routinely tested and collected performance data, such as patient reported outcome measures and compare to historic and published data i.e., gekoâ„¢ therapy vs standard care without gekoâ„¢ therapy |
Up to 12 months from study entry |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcomes |
Up to 84 days from study entry |
|
|
Target Sample Size
|
Total Sample Size="2500"
Sample Size from India="150"
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)
|
15/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/04/2022 |
| 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)
|
Completed |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The gekoâ„¢ Cross Therapy REGISTRY - Wound is a prospective, observational, anonymised data collection Registry with no experimental treatment that will fulfil an unmet need for an observational Registry to provide long-term clinical data to demonstrate patient benefit and regulatory compliance. |