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

April 3, 2013 updated by: HealOr

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

196

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
EXPERIMENTAL: HO/03/03 10µg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 14 weeks inclusive

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ANTICIPATED)

August 1, 2013

Study Registration Dates

First Submitted

June 22, 2009

First Submitted That Met QC Criteria

June 22, 2009

First Posted (ESTIMATE)

June 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 3, 2013

Last Verified

April 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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