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
  Purpose

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 Intervention Phase
Diabetic Foot Ulcer
Drug: HO/03/03 10µg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers (Truheal)

Resource links provided by NLM:


Further study details as provided by HealOr:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 196
Study Start Date: February 2010
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HO/03/03 10µg Drug: HO/03/03 10µg
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926068

  Show 33 Study Locations
Sponsors and Collaborators
HealOr
Clinigene International Ltd
Cato Research
  More Information

No publications provided

Responsible Party: HealOr
ClinicalTrials.gov Identifier: NCT00926068     History of Changes
Other Study ID Numbers: HO-09-01
Study First Received: June 22, 2009
Last Updated: April 3, 2013
Health Authority: India: Drugs Controller General of India
United States: Food and Drug Administration

Keywords provided by HealOr:
Diabetes Mellitus
Foot Ulcer
DFU
Wound healing

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

ClinicalTrials.gov processed this record on October 23, 2014