CTRI/2011/09/001985 [Registered on: 05/09/2011] Trial Registered Prospectively
Last Modified On:
27/08/2013
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
To study the Safety and Efficacy of GRANEXIN GEL plus Standard of Care in comparison to Standard of Care alone in the Treatment of Venous Leg Ulcer
Scientific Title of Study
A Phase II, Randomized, Prospective, Double blind, Parallel group, Multi-center Study to determine the Safety and Efficacy of GRANEXIN GEL in the Treatment of Venous Leg Ulcers
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
2010-VLU-001
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Dr.Chopra Super Specality Hospital,Deapartment of General Surgery, Gurdhuwar Road,Sadar Bazar,Agra-UP Agra UTTAR PRADESH
91-9837144287 91-0562-2225879 Puneet265@yahoo.com
Dr Mohd Yunus Salarshah
Crescent Hospital & Heart Centre
Crescent Hospital & Heart Centre,Department of General surgery,
Behind mout carmel school,
Near Lokmat Square,Dhantoli,
Nagpur-440012,
Maharastra, India Nagpur MAHARASHTRA
K.R. Hospital, Department of Genral Surgery,
NO.979,25th Main Road
Banasari 1 st Stage
Opp PES college Hanumanthanagar
Bangalore-560050
Karnataka, India Bangalore KARNATAKA
M.S. Ramaiah Medical College and Hospitals, Department of Vascular and Endovascular Surgery, OPD.No. 9, New BEL road, MSRIT post,Bangalore-560054,Karnataka India Bangalore KARNATAKA
91-9845290575 91-80-40528402 scdesai@hotmail.com
DrG M Prasad
Pace Cinical Research
Consultant in Diabetiology and Cardiology
Pace Cinical Research ,Center,no-53, Nanda Complex , Ramamurthy Nagar Main Road, Banaswadi, Bangalore- 560043, India Bangalore KARNATAKA
91-9731911630 91-80-41626643 drgmprasad@gmail.com
Dr Prashant Rahate
Rahate Surgical Hospital & ICU
Rahte Surgical Hospital & ICU 517, Department of General surgery, Kolba Swami square, Central Avenue, Nagpur -08 Nagpur MAHARASHTRA
Smt Kashibai Navale General Hospital, Department of Clinical research, First Floor, 49/1, Off Westerly Bypass Highway, Narhe (Ambegaon) Pune-411041, India Pune MAHARASHTRA
91-9822016991 91-20-24392311 snp2311@yahoo.co.in
Dr R Radhakrishnan
Sri Ramachandra Medical Centre
Sri Ramachandra Medical Centre, Department of Vascular Surgery, Room No8, A2 Private Clinic, Ramasamy Udayar Block,
Porur, Chennai 600116.
Tamilnadu, India Chennai TAMIL NADU
Vijaya Hospital / Heart Foundation Department of Vascular surgery, Room No. C-17, Ground Floor, 180,
N. S. K. Salai,
Vadapalani Chennai-600026 Chennai TAMIL NADU
Institutional Ethics Committee Rahate Surgical Hospital & ICU 517, Kolba Swami square, Central Avenue, Nagpur -08 Maharashtra, India
Approved
Institutional Ethics Committee Chopra Super speciality Hospital 16/1 Gurudwara road, Sadar bazaar Agra, UP
Approved
Institutional Ethics Committee Crescent Hospital & Heart Centre, Near Lokmart Square, Dhantoli, Nagpur-440012 Maharashtra, India
Approved
Institutional Ethics Committee K.R. Hospital, NO.979,25th Main Road Banasari 1 st Stage Opp PES college Hanumanthanagar Bangalore-560050 Karnataka, India
Approved
Institutional Ethics Committee M. S. Ramaiah Medical College and Hospitals, New BEL road, MSRIT post, Bangalore-560054 Karnataka, India
Approved
Institutional Ethics Committee Sir Ganga Ram Hospital, Old Rajendra Nagar, New Delhi 110060 India
Approved
Institutional Ethics Committee Smt. Kashibai Navale General Hospital, 49/1, Off Westerly Bypass Highway, Narhe (Ambegaon) Pune-411041, Maharashtra, India
Approved
Institutional Ethics Committee Sri Ramachandra Medical Centre, Sri RamachandraUniversity, Porur, Chennai 600116. Tamilnadu, India
Approved
Institutional Ethics Committee Vijaya Hospital & Heart Foundation Department of Vascular surgery, 180, N. S. K. Salai, Vadapalani, Chennai-600026
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Venous Leg Ulcer,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Control Group: Standard Care would be Wound debridement
Standard Care would be Wound debridement, a non-adherent dressing over the ulcer and GRANEXIN GEL, extending 0.5 inch beyond the ulcer perimeter and inflamed skin margins and a non-occlusive dressing such as fine mesh gauze folded or rolled as a bolster and a self adherent high compression multi layer elastic wrap from metatarsals to tibial plateau
Intervention
GRANEXIN GEL
GRANEXIN GEL is a low molecular weight gap junction (ACT-1) peptide formulated in 1.25% Hydroxyethylcellulose gel for topical applications for the management of wounds. 100 μM concentration of GRANEXIN GEL will be applied at Day 0, Day 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 along with standard of care (ie) a non-adherent dressing over the ulcer and GRANEXIN GEL, extending 0.5 inch beyond the ulcer perimeter and inflamed skin margins and a non-occlusive dressing such as fine mesh gauze folded or rolled as a bolster and a self adherent high compression multi layer elastic wrap from metatarsals to tibial plateau.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Male or female aged 18 years and older.
2a. Female subjects must be post-menopausal or surgically sterilized.
or
2b. Female of child-bearing potential must have negative pregnancy test at screening, and agrees to use hormonal contraceptive or intra-uterine device (IUD) or diaphragm with spermicide or condom with spermicide or abstinence throughout the study.
3. Subjects with ulcers of venous origin, as clinically determined by the investigator by a positive venous reflux test (venous refilling <20 seconds) using Doppler ultrasound for at least 4 weeks prior to screening day, which have not adequately responded to conventional ulcer therapy.
4. Ulcers that extend through the epidermis but not through muscle, tendon, or bone (Stage II or III ulcers as defined by the IAET).
5. Surface ulcer between 0.5 cm2 and 40 cm2 post debridement.
6. Signed informed consent form.
ExclusionCriteria
Details
1. Decrease or increase in the ulcer size by 30% or more during 7 day screening period.
2. Cannot tolerate or comply with compression therapy.
3. An ulcer which shows signs of severe clinical infection, defined as pus oozing from ulcer site.
4. The ulcer to be treated requires operative debridement.
5. An ulcer positive for _-hemolytic streptococcus upon culture.
6. The ulcer has more than 50% slough, significant necrotic tissue, osteomyelitis, bone, tendon, or capsule exposure or avascular ulcer beds.
7. Highly exuding wounds (wounds that require a daily dressing change).
8. ABPI 0.65.
9. Subjects with active systemic infections.10. Subjects with clinically significant medical conditions as determined by the Investigator which would impair wound healing including renal, hepatic, hematologic, neurologic or immune disease. Examples include but are not limited to:
a. Renal insufficiency as an estimated GFR which is 30 mL/min/1.7m2.b. Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range.c. Hepatic insufficiency defined as total bilirubin 2 mg/dL or serum albumin 25 g/L.d. HbA1c 9.0%.e. Hemoglobin 10 g/dL.f. Hematocrit 0.30. g. Platelet count 100,000.
11. Presence of an active systemic or local cancer or tumor of any kind (with the exception of non-melanoma skin cancer).
12. Subjects with active osteomyelitis of the study foot.
13. Subjects with severe rheumatoid arthritis (with more than 20 persistently inflamed joints, or below lower normal limit blood albumin level, or evidence of bone and cartilage damage on x-ray, or inflammation in tissues other than joints) and other collagen vascular diseases.
14. Subjects with active connective tissue disease.
15. Treatment with systemic corticosteroids (15 mg/day), or current immunosuppressive agents.
16. Previous or current radiation therapy or likelihood to receive this therapy during study participation.
17. Pregnant or nursing subjects.
18. Known prior inability or unavailability to complete required study visits during study participation.
19. A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the subjects medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance.
20. Use of any investigational drug or therapy within the 28 days prior to screening.
21. Any other factor which may, in the opinion of the Investigator, compromise participation and follow-up in this study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
The mean percent wound closure.
week 12 from baseline.
Secondary Outcome
Outcome
TimePoints
Mean percent wound closure
4 weeks from baseline
Time taken for 50% wound closure.
from day 3 till study exit
Subject self-assessment of intensity of pain.
from day 3 till study exit
Time to complete wound closure where complete wound closure will be defined as 100% epithelialization of the wound and the absence of drainage from the wound.
from day 3 till study exit
Target Sample Size
Total Sample Size="92" Sample Size from India="92" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This Phase II, prospective, study is designed as a multicenter, double
blind, parallel group study in which subjects with venous leg ulcers will be
randomly allocated to receive 100μM concentration
GRANEXIN GEL plus Standard of Care (SoC) as compared to Standard of Care alone.
The total study duration for efficacy assessments is 12 weeks with additional
12 weeks follow up for safety evaluations. The patients would be
treated with 100
μM concentration of GRANEXIN GEL will be applied at Day 0, Day 3, Week 1, 2, 3,
4, 5, 6, 7, 8, 9, 10, 11 and 12 along with standard of care and the control
group would be treated with standard care alone. The endpoint of the study
would be, mean percent of wound closure from baseline, Subject self-assessment
of intensity of pain, and complete wound closure, defined as 100%
epithelialization of the wound and the absence of drainage from the wound