Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers
Truheal
1 other identifier
interventional
196
2 countries
33
Brief Summary
A prospective, double blind, randomized, placebo controlled, outpatient, parallel group comparison trial to assess the safety and efficacy of HO/03/03 10µg versus Placebo, applied topically once daily for up to 14 weeks in at least 196 subjects diagnosed with Diabetes Mellitus and having a single target non-healing Plantar Neuropathic Diabetic Foot Ulcer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2009
CompletedFirst Posted
Study publicly available on registry
June 23, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedApril 4, 2013
April 1, 2013
3.5 years
June 22, 2009
April 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete ulcer closure
Time to Event Analysis that determines time for incidence of 100% study wound closure per unit of time (days) and the incidence of 100% wound closure per unit of time using the log rank test.
Up to 14 weeks inclusive
Secondary Outcomes (6)
Percent change in wound area at 4 weeks
4 weeks
75% wound closure by or on Study Week 14
Up to 14 weeks inclusive
Incidence of adverse events, changes in vital signs, physical examination, electrocardiogram and laboratory tests from baseline to termination.
14 weeks
Incidence of 100% Closure tested by the Fisher exact 2-tailed test
Up to 14 weeks inclusive
Percent change in granulation tissue at 4 weeks
4 weeks
- +1 more secondary outcomes
Study Arms (2)
HO/03/03 10µg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age between 18 and 80 years, extremes included
- Diagnosed with Diabetes Mellitus Type 1 or Type 2
- Having a documented single target non-healing Plantar Neuropathic Diabetic Foot Ulcer with a minimal duration of 4 weeks prior to the informed consent signature
- Ulcer size at randomization:
- Wagner grade 1, between 2.0 cm2 to 10 cm2, extremes included or;
- Wagner grade 2, between 1.0 cm2 to 10 cm2, extremes included;
- Single target, ulcer on the study foot:
- Wagner grade 1 or;
- Wagner grade 2 (does not involve abscess or osteomyelitis);
- Target ulcer area decreased by ≤ 30% OR ≤ 0.1 cm/wk edge healing rate measured after debridement at screening to after debridement if clinically indicated at randomization.
- Glycosylated Haemoglobin A1c (HbA1c) ≤ 12%;
- Ankle to Brachial Index (ABI) on study foot:
- ≤ ABI ≤ 1.2 or
- ABI \> 1.2 and toe pressure \> 50 mm Hg (ABI measured by Doppler; toe blood pressure measured by toe cuff);
- Diabetic Neuropathy is confirmed by neurological testing
- +2 more criteria
You may not qualify if:
- Subjects meeting one or more of the following criteria cannot be selected:
- 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 that will interfere with treatment compliance
- 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
- Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception or females who test positive on a blood-based pregnancy test
- Have a documented medical history of HIV, HBV or HCV
- 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
- 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 upper normal lab values or any indication of malnourishment (Albumin \< 2.8 g/dL) or any other clinically significant biochemistry, haematology and urinalysis tests;
- Had any clinically significant illness during the last 4 weeks prior to the screening period;
- Have a current malignancy or a past malignancy in the last 5 years other than Basal Cell Carcinoma or is treated by radio/chemotherapy
- Have any signs of clinical infection in the wound (which could be linked to raised body temperature, abscess, osteomyelitis, necrosis or erythema)
- Had any antibiotic treatment during the screening period;
- Had evidence of infection or osteomyelitis on a plain foot x-ray at screening;
- Is bed-ridden or unable to come to the clinic;
- Have more than one target non-healing Diabetic Foot Ulcer per subject;
- Plantar Neuropathic DFU is located on an active Charcot foot;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HealOrlead
- Clinigene International Ltdcollaborator
- Cato Researchcollaborator
Study Sites (33)
Phoenix VA Healthcare System
Phoenix, Arizona, 85012, United States
Center For Clinical Research
Castro Valley, California, 94546, United States
Dr. Ian Gordon
Long Beach, California, 90822, United States
Advanced Clinical Research
Los Angeles, California, 90010, United States
Innovative Medical Technologies, LLC
Los Angeles, California, 90063, United States
California School of Podiatric Medicine at Samuel Merritt University
Oakland, California, 94609, United States
North American Centre for Limb Preservation
New Haven, Connecticut, 06515, United States
Bay Pines VA Healthcare System-Wound Clinic Bay Pines VA Healthcare System-Research Pharmacy
Bay Pines, Florida, 33744, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Doctors Research Network
Miami, Florida, 33143, United States
Capt. James A. Lovell Federal Health Care Center
North Chicago, Illinois, 60064, United States
Deaconess Clinic Downtown-Research Institute
Evansville, Indiana, 47713, United States
St. Vincent Wound Care Center IDI Research
Indianapolis, Indiana, 46032, United States
Cambridge Hospital
Cambridge, Massachusetts, 02139, United States
Center for Curative & Palliative Wound Care Calvary Hospital
New York, New York, 10461, United States
Armstrong County Memorial Hospital Snyder Institute for Vascular Health and Research
Kittanning, Pennsylvania, 16201, United States
Paddington Testing Company
Philadelphia, Pennsylvania, 19103, United States
Martin Foot and Ankle
York, Pennsylvania, 17403, United States
Complete Family Foot Care
McAllen, Texas, 78501, United States
Medanta
Gurgaon, Haryana, 122001, India
Jain Institute of Vascular Sciences
Bangalore, Karnataka, 560052, India
Karnataka Institute of Diabetology
Bangalore, Karnataka, 560069, India
St.John's Hospital
Bangalore, Karnataka, 580034, India
Belgaum Diabetes Centre
Belagavi, Karnataka, 59001, India
Vinaya Hospital and Research Centre
Mangalore, Karnataka, 575003, India
Kunnamkulam Eye and Diabetes Centre
Thrissur, Kerala, 680 503, India
OM Shree Swami Samarth Hospital
Pune, Maharashtra, 411033, India
Patil Hospital
Pune, Maharashtra, 411051, India
MV Hospital for Diabetes Pvt Ltd
Chennai, Tamil Nadu, 600013, India
Dr. V Seshiah Diabetes Research Institute
Chennai, Tamil Nadu, 600029, India
Christian Medical College
Vellore, Tamil Nadu, 632004, India
SK Diabetes Research & Education Center
Kolkata, West Bengal, 700009, India
Advanced Medicare & Research Institute
Kolkata, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2009
First Posted
June 23, 2009
Study Start
February 1, 2010
Primary Completion
August 1, 2013
Last Updated
April 4, 2013
Record last verified: 2013-04