CTRI/2011/09/001984 [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
Safety and Efficacy of GRANEXIN GEL plus Standard of Care in comparison to Standard of Care alone in the Treatment of Diabetic Foot 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 Diabetic Foot Ulcers
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
2010-DFU-001
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Cosmopolitan Medical Centre, No. 8, Department of Diabetology, 5th Main Mariyappa Road( Kullappa Circle), St. Thomas Town Post, Bangalore-560084, India Bangalore KARNATAKA
Crescent Hospital & Heart Centre, Department of Anesthesia and intesive care,
Behind mout carmel school,
Near Lokmat Square,Dhantoli,
Nagpur-440012,
Maharastra, India Nagpur MAHARASHTRA
91-9226151571 91-712-2420698 drmaq@rediffmail.com
Dr Vijay Viswanathan
M.V. Diabetes & Research Centre
M.V. Diabetes & Research Centre, Department of Clinical research, room No, 229, Second Floor, New Block No 4 West Mada Church Street, Royapuram, Chennai-600013 Chennai TAMIL NADU
Pace Cinical Research (Center of Pranav diabetic Center)Center No-57/1, Nanda Complex , Ramamurthy Nagar Main Road, Banaswadi, Bangalore- 560043, India Bangalore KARNATAKA
91-9731911630 91-80-41626643 drgmprasad@gmail.com
Dr Ajay Yadav
Sir Ganga Ram Hospital
Department of Vascular and Endovascular Surgery, First Floor, Room No.1110, Sir Ganga Ram Hospital,
Old Rajendra Nagar,
New Delhi 110060
Central DELHI
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 drmaq@rediffmail.com
DrViswanath Pai
Sri Ramachandra Medical Centre
HOD and Professor
Dept of General Surgery
Sri Ramachandra Medical Centre,Sri RamachandraUniversity,
Porur, Chennai 600116.
Tamilnadu, India
Chennai TAMIL NADU
Insititutional Ethics Committee Sri Ramachandra Medical Centre Chennai-116,Tamilnadu
Approved
Institutional Ethics Committee Sir Ganga Ram Hospital, Old Rajendra Nagar, New Delhi 110060
Approved
Institutional Ethics Committee Chopra Super speciality Hospital 16/1 Gurudwara road, Sadar bazaar Agra, UP
Approved
Institutional Ethics Committee Cosmopolitan Medical Centre, No. 8, 5th Main Mariyappa Road, (Kullappa Circle), St. Thomas Town Post, Bangalore-560084, India
Approved
Institutional Ethics Committee Crescent Hospital & Heart Centre, Near Lokmart Square,Dhantoli, Nagpur-440012,India
Approved
Institutional Ethics Committee M.V. Diabetes & Research Centre No. 4 West Mada Church Street, Royapuram, Chennai-600013
Approved
Institutional Ethics Committee Pace Cinical Research Center, no-53, Nanda Complex , Ramamurthy Nagar Main Road, Banaswadi, Bangalore- 560043, India
Approved
Institutional Ethics Committee Smt. Kashibai Navale General Hospital, 49/1, Off Westerly Bypass Highway, Narhe (Ambegaon) Pune-411041, India
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Diabetic Foot Ulcer,
Intervention / Comparator Agent
Type
Name
Details
Intervention
GRANEXIN GEL
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
Comparator Agent
Wound Debridement and Non occlusive/ Non Adhesive dressing
Standard of Care alone. Standard of care would be wound debridement and Non occlusive/ Non Adhesive dressing
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. Diabetes mellitus (type I or II) with an HbA1c < 10.0%.
4. Diagnosis of neuropathic foot ulcer.
5. Cutaneous, full thickness (University of Texas grade A1), below ankle surface ulcer between 0.5 cm2 and 40 cm2 post debridement.
6. A viable, granulating wound as per investigators discretion.
7. Ulcer present for at least 4 weeks prior to screening day.
8. An Ankle Brachial Index between 0.70 and 1.3 measured at screening.
9. 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 the off-loading method or comply with standard of care.
3. An ulcer which shows signs of severe clinical infection, defined as pus oozing from the ulcer site.
4. The ulcer to be treated requires operative debridement.
5. An ulcer positive for _-hemolytic streptococcus upon culture.
6. Requirement for total contact casts.
7. The ulcer has more than 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure.
8. Highly exuding wounds (wounds that require a daily dressing change).
9. ABPI 0.7 or 1.3 or ankle systolic pressure 70 mm Hg.
10. Subjects with systemic infections.1
1. One of the following findings (only 1 out of 3 tests is required):
a. On Doppler waveform analysis on the dorsalis pedis and posterior tibial arteries monophasic or biphasic flow (with loss of reverse flow) in either foot artery, or
b. A toe: brachial index 0.7 or 1.3, or
c. Transcutaneous oxygen pressure (TcpO2) 40 mm Hg
12. Presence of an active systemic or local cancer or tumor of any kind (with the exception of nonmelanoma skin cancer).
13. Subjects with Congestive heart failure New York Heart Association class II to IV or Coronary heart disease with ST segment elevation myocardial infarction (STEMI) or Coronary Artery Bypass Graft (CABG) or Percutaneous Transluminal Coronary Angioplasty (PTCA) within the last 6 months.
14. Subjects with active osteomyelitis of the study foot.
15. Subjects with active connective tissue disease.
16. Subjects with Acute Charcots neuro-arthropathy as determined by clinical and/or radiographic examination.
17. Active treatment with systemic corticosteroids.
18. Previous or current radiation therapy to the distal lower extremity or likelihood to receive this therapy during study participation.
19. Pregnant or nursing subjects.
20. Subjects with Uncontrolled anemia (Hb 10 g/dL in females and 12 g/dL in males).
21. Subjects with eGFR 25 mL/min.
22. Subjects with poor nutritional status defined as an albumin 25 g/L.
23. Subjects with significant peripheral edema as per Investigators discretion.
24. Known prior inability or unavailability to complete required study visits during study participation.
25. 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.
26. Use of a platelet-derived growth factor within the 28 days prior to screening.
27. Use of any investigational drug or therapy within the 28 days prior to screening.
28. 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 from baseline to 12 weeks
The mean percent wound closure from baseline to 12 weeks
Secondary Outcome
Outcome
TimePoints
Mean percent wound closure at 4 weeks
at 4 weeks
Time taken for 50% wound closure.
during enitre study
Subject self-assessment of intensity of pain.
during enitre study
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
during enitre study
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
It is a double blind, parallel group
Multicentric study in which 92 patients with Diabetic Foot Ulcer will be
enrolled.The study involves two
treatment groups:
Group A:
GRANEXIN
GEL plus standard of care in treatment of diabetic foot ulcer
Group B:
Standard
of care in treatment of diabetic foot ulcer.
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.