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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Clinigene International Ltd
Cato Research
Information provided by (Responsible Party):
HealOr
ClinicalTrials.gov Identifier:
NCT00926068
First received: June 22, 2009
Last updated: April 3, 2013
Last verified: April 2013

June 22, 2009
April 3, 2013
February 2010
August 2013   (final data collection date for primary outcome measure)
Complete ulcer closure [ Time Frame: Up to 14 weeks inclusive ] [ Designated as safety issue: No ]
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.
Incidence of complete ulcer closure [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00926068 on ClinicalTrials.gov Archive Site
  • Percent change in wound area at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 75% wound closure by or on Study Week 14 [ Time Frame: Up to 14 weeks inclusive ] [ Designated as safety issue: No ]
  • Incidence of adverse events, changes in vital signs, physical examination, electrocardiogram and laboratory tests from baseline to termination. [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of 100% Closure tested by the Fisher exact 2-tailed test [ Time Frame: Up to 14 weeks inclusive ] [ Designated as safety issue: No ]
  • Percent change in granulation tissue at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Incidence of improved ulcers [ Designated as safety issue: No ]
  • Time to healing [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in ulcer size. [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events, changes in vital signs, physical examination, electrocardiogram and laboratory tests from baseline to termination. [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Foot Ulcer
  • Drug: HO/03/03 10µg
  • Drug: Placebo
  • Experimental: HO/03/03 10µg
    Intervention: Drug: HO/03/03 10µg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
196
Not Provided
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   India
 
NCT00926068
HO-09-01
Yes
HealOr
HealOr
  • Clinigene International Ltd
  • Cato Research
Not Provided
HealOr
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP