CTRI/2018/10/015923 [Registered on: 08/10/2018] Trial Registered Prospectively
Last Modified On:
03/12/2019
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
A clinical trial study to assess the efficacy and safety of Granexin Gel in the treatment of Diabetic Foot Ulcer
Scientific Title of Study
Phase 3, Randomized, Double-blind, Parallel-group, Vehicle controlled, Multicenter Study of the Efficacy and Safety of Granexin Gel in the Treatment of
Diabetic Foot Ulcer
Academics Research Dept. First Floor
Batra Hospital and Medical Research Centre,
1, Tughlakabad Institutional Area, Mehrauli Badarpur Road, Near Saket Metro Station New Delhi DELHI
9810524493
sudvipul@gmail.com
Dr Brij Mohan
Brij Medical Centre Pvt. Ltd.
Room No. 9, Ground Floor,
Brij Medical Centre Pvt Ltd.,
94 E, Near Panki Police Station,
Gangaganj Colony, Panki, Kanpur Kanpur Nagar UTTAR PRADESH
8263833668
drbrijmohan@bmchospital.in
Dr Sandeep Julka
CHL-Hospitals [Unit of Convenient Hospitals Ltd.,]
Near L.I.G. Square, A.B. Road, Indore MADHYA PRADESH
Site Management Office, 2nd Floor, Sharavati Ward,
KLEs Dr. Prabakar Kore Hospital and MRC,
NH Service Rd, Nehru Nagar Belgaum KARNATAKA
9844445598
victorvikrant@gmail.com
Dr Sanjeev Mohan
KRM Hospital and Research Centre
OPD Room No. 02, Ground floor, KRM Hospital and Research Centre,
3/92-93 Vijayant Khand, Gomti Nagar Lucknow UTTAR PRADESH
7007208089
krmhrclko@gmail.com
Dr Dinesh Agarwal
Marwari Hospital and Research Centre
Room no. 3, 1st floor,
Marwari Hospital and Research Centre,
SJ Road, Athgaon, Guwahati
Kamrup ASSAM
9864061456
drdinesh944@gmail.com
Dr B S Madhu
Mysore Medical College & Research Institute & Associated Hospital
2nd floor, Department of Surgery, Neurosurgical Block, Mysore Medical College & Research Institute & Associated Hospital,
Irwin Road Mysore KARNATAKA
9900513688
drmadhubs@gmail.com
Dr Samir Saini
Parul Hospital of Medical Sciences and Research
PO : Limda, TA :m Waghodia, Vadodara GUJARAT
7433014704
samirsaini@gmail.com
Dr Sushil Jindal
People College of Medical Sciences and Research Centre
Room No. 1, Fourth Floor, Department of Medicine
Peoples College of Medical Sciences and Research Centre
Peoples Campus, Bhanpur, Bhopal
Bhopal MADHYA PRADESH
Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital
Srikakulum- 532001,
Srikakulam ANDHRA PRADESH
9849702720
drprasadaraod@gmail.com
Dr Sandeep Kumar Mathur
S.M.S Medical College and Attached Hospitals
Room No. 42, Fourth floor,
Dhanwantri OPD Block.
S.M.S Medical College and Attached Hospitals.
J.L.N. Marg, Near Albert Hall Museum, Ram Niwas Garden Jaipur RAJASTHAN
9414048666
drsandeepmathur@rediffmail.com
Dr Gyan Chand
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Room No. 104, First Floor, Block-C, Deptt. Endocrine Surgery
.Sanjay Gandhi Postgraduate Institute of Medical Sciences
Rae Bareli Road Lucknow UTTAR PRADESH
9451546353
drgyanchandpgi@gmai.com
Dr Preetam K Ahirrao
Supe Heart and Diabetes Hospital and Research Centre
Clinical Research Department, First Floor, Supe Heart and Diabetes Hospital and Research Center,
Near Rungta School, Gharpure Ghat, Ashok Stambh, Nashik MAHARASHTRA
9860211112
gahirraopreetam@gmail.com
Dr Lily Rodrigues
Surakshaka Multispeciality and Diabetes Hospital
4th Floor, Clinical Research Deptt.,
Surakshaka Multi-Speciality and Diabetes Hospital,
Room No: Doctor’s Cabin,
Ground Floor,
M.I.G – 218,
K.P.H.B Main Road,
Kukatpally Hyderabad ANDHRA PRADESH
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Granexin
Investigational products (Granexin gel or vehicle gel) will be dispensed directly from a provided 5 gram laminate tube, and a sterile applicator will be used to apply a uniform layer of the investigational product gel, approximately 1mm thick, over the target ulcer wound. The target ulcer wound is then to be dressed using a non-adherent dressing, followed by non-occlusive dressing such as mesh gauze.
The dose depends on the size of the wound, Frequency is weekly, Duration of treatment is 12 weeks
Comparator Agent
Vehicle
Investigational products (Granexin gel or vehicle gel) will be dispensed directly from a provided 5 gram laminate tube, and a sterile applicator will be used to apply a uniform layer of the investigational product gel, approximately 1mm thick, over the target ulcer wound. The target ulcer wound is then to be dressed using a non-adherent dressing, followed by non-occlusive dressing such as mesh gauze.
The dose depends on the size of the wound, Frequency is weekly, Duration of treatment is 12 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
85.00 Year(s)
Gender
Both
Details
1. Age 18 years or older
2. Established diagnosis of diabetes mellitus (type I or II)
3. Glycosylated hemoglobin (HbA1c) value < 10.0% at the screening visit
4. Diagnosis of neuropathic foot ulcer by 10 g monofilament test, tuning fork, or cotton wisp
5. Designated foot ulcer meets the following criteria at both the screening and baseline visits: a. Present for at least 4 weeks
b. Full-thickness cutaneous ulcer below the ankle surface
c. University of Texas grade A1
d. Wound area (after debridement) 1 to 40.0 cm2
e. Viable, granulating wound (investigator discretion)
6. Ankle brachial index ≥ 0.7 at both the screening and baseline visits. If the ABI is > 1.30, one of the following confirmatory tests must be performed for the patient to be considered eligible:
a. Does not have a monophasic or biphasic flow (with loss of reverse flow) in the artery of the foot with the target ulcer via doppler waveform analysis of the dorsalis pedis and posterior tibial arteries, as determined by standard practices of the investigator and the site.
b. Transcutaneous oxygen pressure (TcPO2) at the foot > 40 mmHg
7. Signed informed consent
8. Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence throughout until 2 weeks after the last administration of investigational product. Male patients must also agree to use contraception such as a condom.
ExclusionCriteria
Details
1. Change (decrease or increase) in size of the designated target ulcer by greater than or equal to 30 percent during the 7-day screening period
2. Cannot tolerate off-loading methods or cannot comply with study related procedures
3. Has an ulcer that meets any of the following criteria:
a. Shows signs of severe clinical infection, defined as pus oozing from the ulcer site
b. Requires surgical debridement
c. Is positive for β-hemolytic streptococci upon culture performed prior to screening debridement procedure.
d. Has greater than 50 percent slough, significant necrotic tissue, bone, tendon, or capsule exposure
e. Is highly exuding (i.e., requires daily change of dressing)
4. Requires total contact cast
5. Ankle brachial pressure index less than 0.7
6. Has a local or systemic infection or local lymphangitis greater than or equal to 0.5 cm
7. Has any 1 of the following (only 1 of the 2 tests is required):
a. A monophasic or biphasic flow (with loss of reverse flow) in the artery of the foot with the target ulcer via doppler waveform analysis of the dorsalis pedis and posterior tibial arteries
b. Transcutaneous oxygen pressure (TcPO2) at the foot less than 40 mmHg
8. Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigator’s discretion)
9. Congestive heart failure (New York Heart Association class II–IV)
10. Coronary heart disease with ST segment elevation myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within the last 6 months
11. Active osteomyelitis of the foot with the target ulcer detected by x-ray, CT scan, or MRI
12. Active connective tissue disease
13. Acute or chronic Charcot neuro-arthropathy as determined by clinical and/or radiographic examination
14. Active treatment with systemic corticosteroids or topical corticosteroids (for treatment of the target ulcer or any area of the foot). This does not include inhaled corticosteroids or topical corticosteroids used for conditions other than treating the target ulcer or any area of the foot. (Wash out period for systemic corticosteroids is 14 days for inclusion in the study. Wash out
period for topical corticosteroids (for treatment of the target ulcer or any area of the foot) is 14 days for inclusion in the study)
15. Active treatment with systemic antibiotics (wash out period for systemic antibiotics is 7 days for inclusion in the study)
16. Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation
17. Pregnant or nursing mothers
18. Uncontrolled anemia (hemoglobin < 10 g/dL in females and < 12 g/dL in males)
19. Estimated glomerular filtration rate < 25 mL/min
20. Poor nutritional status, defined as an albumin < 25 g/L (< 2,500 mg/dl)
21. Significant peripheral edema as per investigator’s discretion
22. Known inability or unavailability of a patient to complete required study visits during study participation
23. A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the patient medical history, which, in the opinion of the investigator, may pose a threat to patient compliance
24. Use of a platelet-derived growth factor within 28 days before screening
25. Use of any investigational drug or therapy within 28 days before screening
26. Has any other factor which may, in the opinion of the investigator, compromise participation and/or follow-up in the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
To evaluate the efficacy of Granexin gel plus standard-of-care in the treatment of diabetic foot ulcer, as compared with vehicle gel plus standard-of-care and with standard-of-care treatment alone, as measured by investigator assessment of wound closure and by other method
At Week 12
Secondary Outcome
Outcome
TimePoints
To evaluate the safety of Granexin gel plus standard-of-care in the treatment of diabetic foot ulcer, as compared with vehicle gel plus standard-of-care and with standard-of-care treatment alone, by standard methods and immunogenicity testing
Over the 12 week treatment period
Incidence of complete wound closure
at Week 24 (Month 6) based on investigator assessment
Target Sample Size
Total Sample Size="552" Sample Size from India="232" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This study is a Phase 3, Randomized, Double-blind, Parallel-group, Vehicle controlled, Multicenter Study to evaluate the Efficacy and Safety of Granexin Gel plus standard-of-care in the treatment of diabetic foot ulcer, as compared with vehicle gel plus standard-of-care and with standard-of-care treatment alone. Each patient assigned to Granexin gel plus standard-of-care or vehicle gel plus standard-of-care will have the investigational product (i.e., double-blind Granexin gel or vehicle gel) applied to the target ulcer at Day 0 and at each subsequent visit during the treatment period (i.e., Day 3 and Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 visits).Study will be conducted at 43 study centers in United States, Canada, India, Poland, Czech Republic and Hungary.