Overview

This trial is active, not recruiting.

Condition diabetic foot ulcer
Treatments ho/03/03 10µg, placebo
Phase phase 2
Sponsor HealOr
Collaborator Clinigene International Ltd
Start date February 2010
End date August 2013
Trial size 196 participants
Trial identifier NCT00926068, HO-09-01

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
ho/03/03 10µg
(Placebo Comparator)
placebo

Primary Outcomes

Measure
Complete ulcer closure
time frame: Up to 14 weeks inclusive

Secondary Outcomes

Measure
Percent change in wound area at 4 weeks
time frame: 4 weeks
75% wound closure by or on Study Week 14
time frame: 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
Incidence of 100% Closure tested by the Fisher exact 2-tailed test
time frame: Up to 14 weeks inclusive
Percent change in granulation tissue at 4 weeks
time frame: 4 weeks
Incidence of improved ulcers
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria

  • Age between 18 and 80 years, extremes included
  • Diagnosed with Diabetes Mellitus Type 1 or Type 2
  • 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
  • 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;
  • Single target, ulcer on the study foot:
    • Wagner grade 1 or;
    • Wagner grade 2 (does not involve abscess or osteomyelitis);
  • 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.
  • Glycosylated Haemoglobin A1c (HbA1c) ≤ 12%;
  • 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);
  • Diabetic Neuropathy is confirmed by neurological testing
  • Subject should be available for the entire study period, and be able and willing to adhere to protocol requirements
  • Subject has signed the informed consent form prior to any study protocol related procedure

Exclusion Criteria

  • 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
  • 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
  • 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
  • Have a documented medical history of HIV, HBV or HCV
  • 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
  • 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;
  • Had any clinically significant illness during the last 4 weeks prior to the screening period;
  • Have a current malignancy or a past malignancy in the last 5 years other than Basal Cell Carcinoma or is treated by radio/chemotherapy
  • Have any signs of clinical infection in the wound (which could be linked to raised body temperature, abscess, osteomyelitis, necrosis or erythema)
  • Had any antibiotic treatment during the screening period;
  • Had evidence of infection or osteomyelitis on a plain foot x-ray at screening;
  • Is bed-ridden or unable to come to the clinic;
  • Have more than one target non-healing Diabetic Foot Ulcer per subject;
  • Plantar Neuropathic DFU is located on an active Charcot foot;
  • Have hind foot ulcer or have a foot deformity/condition preventing the use of offload footwear;
  • Had a leg revascularization surgery within the last 6 months or be a candidate for revascularization surgery during the course of the study;
  • Glucocorticosteroid treatment (Prednisone >10 mg/day or its equivalent)
  • Inability to stop alternative wound healing treatment (e.g. Becaplermin or other topical products) following debridement

Additional Information

Official title Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers (Truheal)
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by HealOr.