| CTRI Number |
CTRI/2023/03/050855 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Stem Cell Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find the effectiveness of a new allogenic cell-based wound dressing (VELGRAFT) in the treatment of chronic diabetic foot ulcer that have attained granulation. A phase 1 trial. |
|
Scientific Title of Study
|
A prospective, randomized, assessor-blind, active controlled, multi-center study to demonstrate the safety and efficacy of VELGRAFT, an allogenic cell-based wound dressing, in comparison to standard moist wound dressing in management of chronic diabetic foot ulcers that have attained granulation tissue. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CBCC/2020/019; Version 4.0; Dated 12/April/2022 |
Protocol Number |
| CT-02/2022 |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gyan chand |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Endocrine Surgery,
Sanjay Gandhi Post Graduate Institute of Medical Sciences,
Lucknow, Uttar Pradesh, 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9451546353 |
| Fax |
|
| Email |
drgyanchandpgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddharth Pandey |
| Designation |
Vice President (R&D) |
| Affiliation |
Datt Mediproducts Private Limited |
| Address |
56, Community Centre, East of Kailash, New Delhi -110065
South
DELHI
110065
India |
| Phone |
9871011002 |
| Fax |
|
| Email |
lifescience@dattmedi.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Bablani |
| Designation |
Head Clinical Research Operation |
| Affiliation |
Datt Mediproducts Private Limited |
| Address |
56, Community Centre, East of Kailash, New Delhi
New Delhi
DELHI
110065
India |
| Phone |
9999059412 |
| Fax |
|
| Email |
clinical@dattmedi.com |
|
|
Source of Monetary or Material Support
|
| The trial will be insured and study material support would be provided by the sponsor.
The trial will be conducted at 3 sites
1. SGPGI, Lucknow
2. AIIMS, Bhubneshwar
3. PGI, Chandigarh. |
|
|
Primary Sponsor
|
| Name |
Datt Mediproducts Private Limited |
| Address |
56, Community Centre, East of Kailash, New Delhi -110065 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Giri |
All India Institute of Medical Sciences |
Department of Burns & Plastic Surgery.
All India Institute of Medical Sciences,
Bhubaneswar,
Odisha
Khordha
ORISSA |
9438884117
drsanjugiri@gmail.com |
| Dr CHERRING TANDUP |
Department of General Surgery, Postgraduate Institute of Medical Education and Research |
Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH |
8196991007
7087003400
ctandup@gmail.com |
| Dr Arunanshu Behera |
Postgraduate Institute of Medical Education and Research |
Department of General Surgery,
Postgraduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH |
7087009638
abe190859@yahoo.com |
| Dr Gyan chand |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Department of Endocrine Surgery,
Sanjay Gandhi Post Graduate Institute of Medical Sciences,
Lucknow, Uttar Pradesh, 226014
Lucknow
UTTAR PRADESH |
09451546353
drgyanchandpgi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Institute committee for Stem cell Research, Bhubaneshwar |
Approved |
| Institute committee for Stem cell Research, Lucknow |
Approved |
| Institutional Committee on Stem Cell Research, Chandigarh |
Approved |
| Institutional Ethics Committee, AIIMS, Bhubaneswar |
Approved |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
| Institutional Ethics Committee, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E13||Other specified diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
VELGRAFT |
Allogenic cell-based wound dressing, containing living human BM-MSCs and MSCs differentiated into adipocytes on a chitosan-gelatin matrix.
Total expected study duration will be approximately 24-26 weeks consisting
Screening period: up to 14 days (2 weeks)
Treatment period: of 12 weeks (Velgraft on day 0, 15, & 21; Standard moist dressing on day 29, 36, 43, 50, 57, 64, 71, & 78)
Follow-up: At 12 weeks after the completion of treatment period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing and able to provide written informed consent and to comply with the requirements of protocol
2. Subjects ≥ 18 years of age
3. Subjects with type 1 or type 2 diabetes mellitus
4. Subjects with foot ulcer for greater than 4 weeks and less than 54 weeks at the time of screening visit
5. Subject’s foot ulcer located below malleoli and is between 1-20 cm2 (both inclusive) in size on day 1
6. Subject has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
a. Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, OR
b. ABIs with results of ≥ 0.7 and ≤ 1.2, OR
c. Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg
7. Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule (Grade 1 by Wagner’s scale or Grade A-I by University of Texas Staging System), that has not shown signs of healing despite standard treatment (refer Appendix- 19.1 and 19.2)
8. Subject is able and willing to wear an off-loading device or orthopedic shoe
9. Subject whose screening laboratory values are within normal range or are considered clinically not significant by the Investigator
10. Female subjects willing to use adequate contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility) throughout the study
|
|
| ExclusionCriteria |
| Details |
1. Subjects with gangrene present on any part of the affected foot
2. Subjects who are hypersensitive to VELGRAFT and its contents
3. Subjects with ulcer of non-diabetic pathophysiology
4. If the subjects ulcer is over a Charcot deformity
5. Subjects with cellulitis, or other evidence of infection
6. Subject is currently being treated with chemotherapeutic agents and corticosteroids
7. Subjects with HbA1c > 10.0%
8. Subjects with positive test for HIV, HBV or HCV
9. Subject with a positive Coronavirus infection (COVID-19) on the basis of RT-PCR of respiratory specimen
10. Known hypersensitivity, contraindication or intolerance to any of the components of the investigational product
11. Subjects had a previous lower extremity amputation.
12. Subjects who have received allograft, autograft, xenograft, or cellular therapy within last 30 days of screening visit
13. Female subjects who are nursing, pregnant, or planning on becoming pregnant during the study
14. Subjects with mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
15. Subject is currently participating or has participated in another clinical study within the past 30 days prior to enrollment
16. Any coexisting serious or uncontrolled comorbid condition that may not make the patient eligible to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Proportion of participants with complete wound closure at 12 weeks. Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements
2. Proportion of participants reporting treatment emergent adverse events during the study period |
12 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Proportion of participants with complete wound closure by 24 weeks
2. Time to reach complete wound closure
3. Percentage of wound closure at 12 weeks
4. Patient reported outcome measures (36-item short form (SF-36), Quality of life in neurological disorders (Neuro QoL) and WHO-5 well-being scale) |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="22" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
28/03/2023 |
| Date of Study Completion (India) |
27/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet available. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A new allogenic cell-based wound dressing is been tested for its safety and efficacy in patients with chronic diabetic foot ulcer that have attained granulation. evaluation of their quality of life after the treatment. |