Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers (Truheal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00926068
Recruitment Status : Unknown
Verified April 2013 by HealOr.
Recruitment status was:  Active, not recruiting
First Posted : June 23, 2009
Last Update Posted : April 4, 2013
Clinigene International Ltd
Cato Research
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: HO/03/03 10µg Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers (Truheal)
Study Start Date : February 2010
Estimated Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: HO/03/03 10µg Drug: HO/03/03 10µg
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Complete ulcer closure [ Time Frame: Up to 14 weeks inclusive ]
    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.

Secondary Outcome Measures :
  1. Percent change in wound area at 4 weeks [ Time Frame: 4 weeks ]
  2. 75% wound closure by or on Study Week 14 [ Time Frame: Up to 14 weeks inclusive ]
  3. Incidence of adverse events, changes in vital signs, physical examination, electrocardiogram and laboratory tests from baseline to termination. [ Time Frame: 14 weeks ]
  4. Incidence of 100% Closure tested by the Fisher exact 2-tailed test [ Time Frame: Up to 14 weeks inclusive ]
  5. Percent change in granulation tissue at 4 weeks [ Time Frame: 4 weeks ]
  6. Incidence of improved ulcers

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age between 18 and 80 years, extremes included
  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:

Subjects meeting one or more of the following criteria cannot be selected:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00926068

  Hide Study Locations
United States, Arizona
Phoenix VA Healthcare System
Phoenix, Arizona, United States, 85012
United States, California
Center For Clinical Research
Castro Valley, California, United States, 94546
Dr. Ian Gordon
Long Beach, California, United States, 90822
Advanced Clinical Research
Los Angeles, California, United States, 90010
Innovative Medical Technologies, LLC
Los Angeles, California, United States, 90063
California School of Podiatric Medicine at Samuel Merritt University
Oakland, California, United States, 94609
United States, Connecticut
North American Centre for Limb Preservation
New Haven, Connecticut, United States, 06515
United States, Florida
Bay Pines VA Healthcare System-Wound Clinic Bay Pines VA Healthcare System-Research Pharmacy
Bay Pines, Florida, United States, 33744
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Doctors Research Network
Miami, Florida, United States, 33143
United States, Illinois
Capt. James A. Lovell Federal Health Care Center
North Chicago, Illinois, United States, 60064
United States, Indiana
Deaconess Clinic Downtown-Research Institute
Evansville, Indiana, United States, 47713
St. Vincent Wound Care Center IDI Research
Indianapolis, Indiana, United States, 46032
United States, Massachusetts
Cambridge Hospital
Cambridge, Massachusetts, United States, 02139
United States, New York
Center for Curative & Palliative Wound Care Calvary Hospital
New York, New York, United States, 10461
United States, Pennsylvania
Armstrong County Memorial Hospital Snyder Institute for Vascular Health and Research
Kittanning, Pennsylvania, United States, 16201
Paddington Testing Company
Philadelphia, Pennsylvania, United States, 19103
Martin Foot and Ankle
York, Pennsylvania, United States, 17403
United States, Texas
Complete Family Foot Care
Mc Allen, Texas, United States, 78501
Gurgaon, Haryana, India, 122001
Jain Institute of Vascular Sciences
Bangalore, Karnataka, India, 560052
Karnataka Institute of Diabetology
Bangalore, Karnataka, India, 560069
St.John's Hospital
Bangalore, Karnataka, India, 580034
Belgaum Diabetes Centre
Belgaum, Karnataka, India, 59001
Vinaya Hospital and Research Centre
Mangalore, Karnataka, India, 575003
Kunnamkulam Eye and Diabetes Centre
Thrissur, Kerala, India, 680 503
OM Shree Swami Samarth Hospital
Pune, Maharashtra, India, 411033
Patil Hospital
Pune, Maharashtra, India, 411051
MV Hospital for Diabetes Pvt Ltd
Chennai, Tamil Nadu, India, 600013
Dr. V Seshiah Diabetes Research Institute
Chennai, Tamil Nadu, India, 600029
Christian Medical College
Vellore, Tamilnadu, India, 632004
SK Diabetes Research & Education Center
Kolkata, West Bengal, India, 700009
Advanced Medicare & Research Institute
Kolkata, India
Sponsors and Collaborators
Clinigene International Ltd
Cato Research

Responsible Party: HealOr Identifier: NCT00926068     History of Changes
Other Study ID Numbers: HO-09-01
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by HealOr:
Diabetes Mellitus
Foot Ulcer
Wound healing

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases