Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers
NCT ID: NCT00926068
Last Updated: 2013-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
196 participants
INTERVENTIONAL
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HO/03/03 10µg
HO/03/03 10µg
Placebo
Placebo
Interventions
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HO/03/03 10µg
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with Diabetes Mellitus Type 1 or Type 2
3. 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
4. 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;
5. Single target, ulcer on the study foot:
* Wagner grade 1 or;
* Wagner grade 2 (does not involve abscess or osteomyelitis);
6. 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.
7. Glycosylated Haemoglobin A1c (HbA1c) ≤ 12%;
8. Ankle to Brachial Index (ABI) on study foot:
* 0.7 ≤ ABI ≤ 1.2 or
* ABI \> 1.2 and toe pressure \> 50 mm Hg (ABI measured by Doppler; toe blood pressure measured by toe cuff);
9. Diabetic Neuropathy is confirmed by neurological testing
10. Subject should be available for the entire study period, and be able and willing to adhere to protocol requirements
11. Subject has signed the informed consent form prior to any study protocol related procedure
Exclusion Criteria
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 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 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
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 upper 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. Have any signs of clinical infection in the wound (which could be linked to raised body temperature, abscess, osteomyelitis, necrosis or erythema)
10. Had any antibiotic treatment during the screening period;
11. Had evidence of infection or osteomyelitis on a plain foot x-ray at screening;
12. Is bed-ridden or unable to come to the clinic;
13. Have more than one target non-healing Diabetic Foot Ulcer per subject;
14. Plantar Neuropathic DFU is located on an active Charcot foot;
15. Have hind foot ulcer or have a foot deformity/condition preventing the use of offload footwear;
16. Had a leg revascularization surgery within the last 6 months or be a candidate for revascularization surgery during the course of the study;
17. Glucocorticosteroid treatment (Prednisone \>10 mg/day or its equivalent)
18. Inability to stop alternative wound healing treatment (e.g. Becaplermin or other topical products) following debridement
18 Years
80 Years
ALL
No
Sponsors
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Clinigene International Ltd
INDUSTRY
Cato Research
INDUSTRY
HealOr
INDUSTRY
Responsible Party
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Locations
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Phoenix VA Healthcare System
Phoenix, Arizona, United States
Center For Clinical Research
Castro Valley, California, United States
Dr. Ian Gordon
Long Beach, California, United States
Advanced Clinical Research
Los Angeles, California, United States
Innovative Medical Technologies, LLC
Los Angeles, California, United States
California School of Podiatric Medicine at Samuel Merritt University
Oakland, California, United States
North American Centre for Limb Preservation
New Haven, Connecticut, United States
Bay Pines VA Healthcare System-Wound Clinic Bay Pines VA Healthcare System-Research Pharmacy
Bay Pines, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Doctors Research Network
Miami, Florida, United States
Capt. James A. Lovell Federal Health Care Center
North Chicago, Illinois, United States
Deaconess Clinic Downtown-Research Institute
Evansville, Indiana, United States
St. Vincent Wound Care Center IDI Research
Indianapolis, Indiana, United States
Cambridge Hospital
Cambridge, Massachusetts, United States
Center for Curative & Palliative Wound Care Calvary Hospital
New York, New York, United States
Armstrong County Memorial Hospital Snyder Institute for Vascular Health and Research
Kittanning, Pennsylvania, United States
Paddington Testing Company
Philadelphia, Pennsylvania, United States
Martin Foot and Ankle
York, Pennsylvania, United States
Complete Family Foot Care
McAllen, Texas, United States
Medanta
Gurgaon, Haryana, India
Jain Institute of Vascular Sciences
Bangalore, Karnataka, India
Karnataka Institute of Diabetology
Bangalore, Karnataka, India
St.John's Hospital
Bangalore, Karnataka, India
Belgaum Diabetes Centre
Belagavi, Karnataka, India
Vinaya Hospital and Research Centre
Mangalore, Karnataka, India
Kunnamkulam Eye and Diabetes Centre
Thrissur, Kerala, India
OM Shree Swami Samarth Hospital
Pune, Maharashtra, India
Patil Hospital
Pune, Maharashtra, India
MV Hospital for Diabetes Pvt Ltd
Chennai, Tamil Nadu, India
Dr. V Seshiah Diabetes Research Institute
Chennai, Tamil Nadu, India
Christian Medical College
Vellore, Tamil Nadu, India
SK Diabetes Research & Education Center
Kolkata, West Bengal, India
Advanced Medicare & Research Institute
Kolkata, , India
Countries
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Other Identifiers
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HO-09-01
Identifier Type: -
Identifier Source: org_study_id
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