| CTRI Number |
CTRI/2011/091/000202 [Registered on: 24/02/2011] |
| Last Modified On: |
20/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Study on the safety and efficacy of BIOCHAPERONE 1 in the treatment of diabetic foot ulcers.
|
Scientific Title of Study
Modification(s)
|
A phase I/II/, multicentre, randomized, controlled and open label trial comparing the efficacy and safety of three dose regimens of BioChaperone PDGF-BB to becaplermin gel for the treatment of diabetic foot ulcer. |
| Trial Acronym |
BC1-CT1 |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| BC1- CT1 |
Protocol Number |
| NCT01098357 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr T C Raghuram |
| Designation |
|
| Affiliation |
|
| Address |
Virchow Biotech Pvt. Ltd.
Flat No. 101 & 102, Rams Enclave, Near Gokul Theatre,, Erragadda
Hyderabad
ANDHRA PRADESH
500018
India |
| Phone |
040-23800924 |
| Fax |
040-23800825 |
| Email |
tcraghuram@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr T C Raghuram |
| Designation |
|
| Affiliation |
|
| Address |
Virchow Biotech Pvt. Ltd.
Plot No. 4, S.V. Co-operative Indl. Estate, IDA Jeedimetla
Hyderabad
ANDHRA PRADESH
500018
India |
| Phone |
040-23800924 |
| Fax |
040-23800825 |
| Email |
tcraghuram@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Hemanth Nandigala |
| Designation |
|
| Affiliation |
|
| Address |
Virchow Biotech Pvt. Ltd.
Plot No. 4, S.V co-operative Indl. Estate, IDA Jeedimetla,
Hyderabad
ANDHRA PRADESH
500018
India |
| Phone |
040-23800924 |
| Fax |
040-23800825 |
| Email |
hnandigala@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Virchow Biotech Pvt. Ltd. |
|
Primary Sponsor
Modification(s)
|
| Name |
Virchow Biotech Pvt Ltd |
| Address |
Plot No. 4, S.V. Co-operative Indl. EstateIDA Jeedimetla, Hyderabad - 500055 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Adocia |
115 avenue Lacassagne 69003 LyonFrance |
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Karthika Laksmi |
Amrutha Diabetic Centre |
Road No.12, Banjara Hills-500018
Hyderabad
ANDHRA PRADESH |
karthika@kanukolamu.com |
| Dr. Sharad Pendsey |
Diabetes Clinics & Research centre |
Shreeniwas,Opp; Dhantoli Park, Dhantoli-440012
Nagpur
MAHARASHTRA |
+91 98 23 078 398
sharad_ngp@sancharnet.in |
| Dr. E. D. Prasad |
Dr. Mohan's Diabetes Speciality Centre |
NTR Stadium ,Lower Tankbund -500070
Hyderabad
ANDHRA PRADESH |
|
| Dr. Santhosh Babu |
MN Area Hospital |
Malakpet,-500036
Hyderabad
ANDHRA PRADESH |
|
| Dr. Kalavati Prasad |
Prasad Multi Speciality Centre |
8-3-228/96;1 Rehmatnadar,Yousufguda-500045
Hyderabad
ANDHRA PRADESH |
04023831825
kalaearnest@hotmail.com |
| Dr Arun Bal |
Raheja Hospital |
Mahim West,-400016
Mumbai
MAHARASHTRA |
+91 98201 28656
arunbal@vsnl.net |
| Dr Ghanshyam Goyal |
S.K. Diabetes Research and Education Centre |
SVS Marwari Hospital Campus,118, Raja Ram Mohan Roy Sarani-700 009
Kolkata
WEST BENGAL |
9165214108
drgsgoyal@hotmail.com |
| Dr. Deendayal Bung |
Shravana Hospital |
5/3/847,Mozamjahi Market-500001
Hyderabad
ANDHRA PRADESH |
drdbung@yahoo.com |
| 8. Dr. V.R. Vachharajani |
Vijay Vachharajani Memorial |
Diabetic Foot Hospital,13/3 Jagnath Plot,-360001
Rajkot
GUJARAT |
2812460733
vibhakar1@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethic committee, Amrutha Diabetic centre |
Approved |
| Ethics Committee, Dr. Mohan,s Diabetes Specialities Centre |
Approved |
| Ethics Committee, Prasads multispeciality Hospital |
Approved |
| Ethics Committee, Prasads multispeciality Hospital |
Approved |
| Ethics Committee, SK Diabetes Research and Education Centre |
Approved |
| Ethics Committee: Rotary Midtown Diabetic Clinic |
Approved |
| Hyderabad Central Ethics Comittee, Shravana Hospital |
Approved |
| Hyderabad Central Ethics Committee, MN Area Hospital |
Approved |
| Institutional Review Board of SL Raheja Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
- BioChaperone PDGF-BB High Dose, |
BioChaperone PDGF-BB is applied as a spray every two days at the dose of 25 µg/cm2 for up to 20 weeks |
| Intervention |
- BioChaperone PDGF-BB Low Dose |
BioChaperone PDGF-BB is applied as a spray every two days at the dose of 12.5 µg/cm2 for up to 20 weeks ; |
| Intervention |
- Biochaperone PDGF-BB Very Low Dose |
BioChaperone PDGF-BB is applied as a spray every two days at the dose of 4 µg/cm2 for up to 20 weeks |
| Comparator Agent |
Becaplermin gelRegranex® Gel 0.01%) |
becaplermin gel is applied once daily at the dose of 6.25 µg/cm2 for up to 20 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus.
2.Single full-thickness plantar ulcer of the extremity (below the malleolus) extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles (grade IA as defined by University of Texas Diabetic Wound Classification).
? Chronic ulcer of at least six weeks despite appropriate wound care.
3. Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 10 cm², both inclusive.
4. Well controlled infection or cellulitis (systemic antibiotherapy).
5. Peripheral neuropathy as assessed by Semmes-Weinstein monofilament test or by the bio esthesimeter (vibration perception threshold).
6. Adequate arterial blood supply, to be measured by (color) doppler ultrasonography, ankle brachial pressure index > 0.60, or ankle systolic pressure > 70 mmHg or toe pressure > 30 mmHg. Ankle brachial pressure index should be lower than 1.3 (which is frequently related to medial artery calcification.
7. Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing.
8. Signed informed consent before any study procedure.
|
|
| ExclusionCriteria |
| Details |
1. Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers.
2. Active ulcer infection assessed by clinical examination and radiographic if necessary. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
? Active osteomyelitis affecting the area of the target ulcer.
? Poorly controlled diabetes (uncontrolled glycemia: HbA1c ≥ 12%), renal failure (serum creatinine > 3.0 mg/dL), poor nutritional status (albumin < 3.0 g/dL or total protein < 6.5 g/dL).
3. Known connective tissue or malignant disease.
4. Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy.
8. Use of investigational drug/device within 30 days.
9. Topical application of any advance wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) within 7 days.
6. Vascular reconstruction within 8 weeks.
7. Patients expected to be noncompliant with the protocol (not available for the duration of the trial, treatment or wound care compliance), or felt to be unsuitable by the Investigator for any other reason.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The incidence of complete wound healing |
20weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Time to achieve complete wound closure |
10 weeks |
| percentage reduction in total ulcer surface area at each visit |
once in a week |
|
Target Sample Size
Modification(s)
|
Total Sample Size="192"
Sample Size from India="192"
Final Enrollment numbers achieved (Total)= "192"
Final Enrollment numbers achieved (India)="192" |
Phase of Trial
Modification(s)
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
18/06/2010 |
| Date of Study Completion (India) |
05/09/2011 |
| Date of First Enrollment (Global) |
18/06/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Diabetic foot ulcer is a common complication of diabetes that occurs in an estimated 15% of diabetic patients. Infection and gangrene, the two major complications of ulcers, lead to amputation in 4 to 7 per 1.000 patients with diabetes. With an over 5% worldwide prevalence of diabetes, the morbidity and mortality and the expenses associated with diabetic foot ulcers are substantial both for the patients and for the health care systems. The standard wound care of diabetic foot ulcer relies primarily on pressure relief, debridement and maintenance of a moist wound environment. In addition, growth factor therapy with platelet-derived growth factor (PDGF-BB) has demonstrated significant clinical benefit by increasing the incidence of complete wound closure and by accelerating wound healing. RhPDGF-BB formulated as a gel (Regranex® Gel 0.01%, Systagenix Wound Management, formerly Johnson & Johnson; and Healace®, Virchow Biotech Pvt, Ltd) is the only growth factor approved for the treatment of neuropathic diabetic foot ulcers. However, the limited efficacy of Regranex® Gel (healing rate only increased by 15% versus placebo, still leaving 50% of the patients unhealed), the inconvenience of the treatment regimen (daily application of the gel and once or twice daily wound care), and the high cost of the associated nursing care are strong impediments to its use in routine ulcer care management. Adocia has developed BioChaperone PDFG-BB, a new liquid formulation designed for an application of rhPDGF-BB as a spray, and only every two days, hence reducing the burden and nursing cost associated with the gel dose regimen. The aim of this study is to establish the proof of concept in a Phase I/II clinical trial with two objectives: i) establish equivalence to Regranex® Gel with two major advantages (improved compliance and reduced nursing care and thus costs), and ii) assess the efficacy of a double dose. |