| CTRI Number |
CTRI/2009/091/000546 [Registered on: 03/12/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
|
Study with HO/03/03 in the treatment of Plantar Neuropathic Diabetic Foot Ulcer. |
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Scientific Title of Study
|
Safety and efficacy of HO/03/03 in the treatment of Planatar Neuropathic Diabetic Foot Ulcers. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| HO-09-01 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
Not Applicable
N/A
India |
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Anand Eswaraiah |
| Designation |
|
| Affiliation |
Clinigene International Ltd. |
| Address |
Clinigene International Ltd
Semicon Park, Tower 1, Hosur Road, Electronic city
Bangalore
KARNATAKA
560 100
India |
| Phone |
+91 80 28082728 |
| Fax |
+91 80 2852 2989 |
| Email |
anand.eswaraiah@clinigeneintl.com |
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Details of Contact Person
Public Query
|
| Name |
Dr. Ramesh Thimmaiah |
| Designation |
|
| Affiliation |
|
| Address |
Clinigene International Ltd
Semicon Park, Tower 1, Hosur Road, Electronic city
Bangalore
KARNATAKA
560 100
India |
| Phone |
+91 80 28082748 |
| Fax |
+91 080 2852 2989 |
| Email |
ramesh.thimmaiah@clinigeneintl.com |
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Source of Monetary or Material Support
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| HealOr ltd.,
3 Prof Chaim Perkeris str
Rehovot 76702 Israel
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Primary Sponsor
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| Name |
HealOr Ltd. |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Neeta R. Deshpande |
Belgaum Diabetes Centre |
Ground and Second floor,Maruti Galli-590001
Belgaum
KARNATAKA |
+918314215380
neetarohit@gmail.com |
| Dr. Nihal Thomas |
Christian Medical college |
Depratment of Endocrinology,-632004
Vellore
TAMIL NADU |
|
| Dr. V Seshaiah |
Dr. V Seshiah Diabetes Research Institute |
729, Poonamalle High Road,-600029
Chennai
TAMIL NADU |
91 44 26641414
vseshiah@gmail.com |
| Dr. K R Suresh |
Jain Institute of Vascular Sciences, |
Bhagwan Mahaveer Jain Hospital,Miller Road, Vasanth Nagar, -560052
Bangalore
KARNATAKA |
91 80 22207188
research_jainvascular@hotmail.com |
| Dr. M.R Mohan |
Karnataka Institute of Diabetology |
SJIC Campus, Bannerghatta road,9th block Jayanagar-560069
Bangalore
KARNATAKA |
91 9243430878
|
| Dr. Shameer Sulaiman |
Kunnamkulam Eye and Diabetes Centre |
Chorus Building,Guruvayoor Road-680503
|
04885211911
kedc.research@gmail.com |
| Dr. Rajiv Parakh |
Medanta- The medicity |
Sector 38,-122001
Gurgaon
HARYANA |
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| Dr. Vijay Vishwanathan & Dr. Rajesh |
MV Hospital for Diabetes Pvt Ltd |
,-
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| Dr. Prashant Mahajan |
Om shree Swami samarth hospital |
Opp. Chaitanya sabhagurha,60, pawana nagar, chinchwad -411033
Pune
MAHARASHTRA |
09881504812
02027355230
drmahajanp@gmail.com |
| Dr. Liteen Patil |
Patil Hospital |
S.No 28, Swaroop building, ,Hingne Khurd-411051
Pune
MAHARASHTRA |
0206470623255
02064706232
litinpatil@gmail.com |
| Dr. Ghanshyam Goyal |
S.K Diabetes & research Center |
SVS Marwari Hospital Campus,118, Raja Ram Mohan Roy Sarani-700009
Kolkata
WEST BENGAL |
91 9830400450
drgsgoyal@hotmail.com |
| Dr. Hemanth Kumar Pandharpurkar |
St. John's Medical College & Hospital |
Department of Surgery, 2nd floor, St John's Medical College &Hospital,Koramangala, Sarjapur Road-580034
Bangalore
KARNATAKA |
91 9845118148
|
| Dr. Hansraj Alwa |
Vinaya Hospital and Research Centre |
PO Box 717,Karangalpady-575003
Bangalore
KARNATAKA |
9343562622
8244273761
drhansrajalwa@yahoo.com |
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Details of Ethics Committee
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| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Bhagwan Mahaveer Jain Hospital (BMJH) Ethics Committee on Human Research, Bangalore |
Approved |
| Ethics committee, Dr. V Seshiah Diabetes Research Institute, Chennai |
Approved |
| Ethics committee, MV Hospital for Diabetes Pvt Ltd, Chennai |
Approved |
| Ethics Committee, S.V.S Marwari Hospital, Kolkata |
Approved |
| Ethics Committee, Sir Ganga Ram Hospital, New Delhi |
Approved |
| I.E.C. Consultants, Karnataka Institute of Diabetology-Bangalore |
Approved |
| Institutional Ethical Review Board, St. John's Medical College & Hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Diabetic Foot Ulcer on plantar surface, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HO/03/03 10 µg |
Once daily dose for upto 14 weeks |
| Comparator Agent |
Placebo |
Once daily dose for upto 14 weeks |
|
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1. Age between 18 and 80 years, extremes included;
2. Diagnosed with Diabetes Mellitus Type 1 or Type 2;
3. Having a documented single non-healing Plantar Neuropathic Diabetic Foot Ulcer (per subject) with a minimal duration of 4 weeks prior to the informed consent signature;
4. Ulcer size at randomization between 1.0 cm2 to 10 cm2, extremes included;
5. Single, full thickness ulcer on the study foot, depth is no more than exposed muscle ? Wagner grade 1 (does not involve exposed tendon,ligament, joint capsule, fascia or bone, no abscess or osteomyelitis);
6. Glycosylated Haemoglobin A1c (HbA1c) <= 12%;
7. Ankle to Brachial Index (ABI) on study foot:
1. 0.7 <= ABI <= 1.2 or
2. ABI > 1.2 and toe pressure > 50 mm Hg
(ABI measured by Doppler; toe blood pressure measured in a vascular lab);
8. Diabetic Neuropathy is confirmed by neurological testing
9. Subject should be available for the entire study period, and be able and willing to adhere to protocol requirements;
10.Subject has signed the informed consent form prior to any study protocol related procedure; |
|
| ExclusionCriteria |
| Details |
1. Anamnesis of current or recent past (within the last 2 years) abuse of alcohol, barbiturates, benzodiazepines, amphetamines, narcotics, cocaine,psychoactive drugs or other abused substances (licit or illicit) that will
interfere with treatment compliance;
2. Use of growth factors, skin graft or participation in an investigational study within the last 30 days prior to the beginning of the screening period;
3. Females who are pregnant, lactating, of child-bearing potential, or postmenopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a blood-based pregnancy test.
4. Have a documented medical history of HIV, HBV or HCV;
5. Have a documented medical history of a significant cardiac, pulmonary, gastrointestinal, endocrine (other than Diabetes Mellitus type 1 or 2), metabolic, neurological, hepatic or nephrologic disease and/or receiving dialysis;
6. Anaemia (Haemoglobin < 9 gram/dL for females or Haemoglobin < 10 gram/dL for males) or White Blood Cells count > 11,000/μL or Platelets count < 100,000/μL or impaired renal function (Creatinine > 3 mg/dL) or
liver function tests > 3 times normal lab values or any indication of malnourishment (Albumin < 2.8 g/dL) or any other clinically significant biochemistry, haematology and urinalysis tests;
7. Had any clinically significant illness during the last 4 weeks prior to the screening period;
8. Have a current malignancy or a past malignancy in the last 5 years other than Basal Cell Carcinoma or is treated by radio/chemotherapy;
9. Ulcer involves or exposes tendon, ligament, joint, fascia or bone at wound site;
10.Have any signs of clinical infection in the wound (which could be linked to raised body temperature), abscess, osteomyelitis, necrosis or erythema);
11.Had any antibiotic treatment during the screening period;
12.Had evidence of infection or osteomyelitis on a plain foot x-ray at screening;
13.Is bed-ridden or unable to come to the clinic;
14.Have more than one non-healing Diabetic Foot Ulcer per subject;
15.Plantar Neuropathic DFU is located on an active Charcot foot;
16.Have hind foot ulcer or have a foot deformity/condition preventing the use of offload footwear;
17.Had a leg revascularization surgery within the last 6 months or be a candidate for revascularization surgery during the course of the study;
18.Glucocorticosteroid treatment (Prednisone >10 mg/day or its equivalent);
19.Ulcer decreased in size ≥ 30% during the screening period in the 2 weeks from size measurement after debridement to size at randomization;
20. Inability to stop alternative wound healing treatment (e.g. Becaplermin or other topical products) following debridement; |
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Method of Generating Random Sequence
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Permuted block randomization, variable |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Complete Ulcer Closure |
At up to 14 weeks scored dichotomously:
0 - 'No Complete Closure'
1 - 'Complete Closure'
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Secondary Outcome
|
| Outcome |
TimePoints |
| -Time to Complete Closure and
Absolute change in Ulcer Area as measure by size at baseline subtracted from size at either: Complete closure or End of trial (or last observed value; LOV) |
depends on patient |
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Target Sample Size
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Total Sample Size="146"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 2 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/02/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This is a prospective, double blind, randomized, placebo controlled,
outpatient, parallel group comparison trial will assess the efficacy
and safety of HO/03/03 10μg vs. Placebo applied topically once
daily for up to 14 weeks in at least 146 subjects diagnosed with
Diabetes Mellitus and having a single non-healing Plantar
Neuropathic Diabetic Foot Ulcer. |