Clinical trial NCT00926068: Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers
Official title: Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers (Truheal)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetic Foot Ulcer
Keywords: Diabetes Mellitus
Foot Ulcer
DFU
Wound healing
Lead sponsor: HealOr
Sponsor class: INDUSTRY
Collaborators: name: Clinigene International Ltd
name: Cato Research
First posted: 2009-06-23
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Complete ulcer closure
timeFrame: Up to 14 weeks inclusive
Secondary outcomes:
measure: Percent change in wound area at 4 weeks
timeFrame: 4 weeks
measure: 75% wound closure by or on Study Week 14
timeFrame: Up to 14 weeks inclusive
measure: Incidence of adverse events, changes in vital signs, physical examination, electrocardiogram and laboratory tests from baseline to termination.
timeFrame: 14 weeks
measure: Incidence of 100% Closure tested by the Fisher exact 2-tailed test
timeFrame: Up to 14 weeks inclusive
measure: Percent change in granulation tissue at 4 weeks
timeFrame: 4 weeks
measure: Incidence of improved ulcers
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Healthcare System
state: Arizona
city: Castro Valley
country: United States
facility: Center For Clinical Research
state: California
city: Long Beach
country: United States
facility: Dr. Ian Gordon
state: California
city: Los Angeles
country: United States
facility: Advanced Clinical Research
state: California
city: Los Angeles
country: United States
facility: Innovative Medical Technologies, LLC
state: California
city: Oakland
country: United States
facility: California School of Podiatric Medicine at Samuel Merritt University
state: California
city: New Haven
country: United States
facility: North American Centre for Limb Preservation
state: Connecticut
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System-Wound Clinic Bay Pines VA Healthcare System-Research Pharmacy
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Miami
country: United States
facility: Doctors Research Network
state: Florida
city: North Chicago
country: United States
facility: Capt. James A. Lovell Federal Health Care Center
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Downtown-Research Institute
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Wound Care Center IDI Research
state: Indiana
city: Cambridge
country: United States
facility: Cambridge Hospital
state: Massachusetts
city: New York
country: United States
facility: Center for Curative & Palliative Wound Care Calvary Hospital
state: New York
city: Kittanning
country: United States
facility: Armstrong County Memorial Hospital Snyder Institute for Vascular Health and Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Paddington Testing Company
state: Pennsylvania
city: York
country: United States
facility: Martin Foot and Ankle
state: Pennsylvania
city: Mc Allen
country: United States
facility: Complete Family Foot Care
state: Texas
city: Gurgaon
country: India
facility: Medanta
state: Haryana
city: Bangalore
country: India
facility: Jain Institute of Vascular Sciences
state: Karnataka
city: Bangalore
country: India
facility: Karnataka Institute of Diabetology
state: Karnataka
city: Bangalore
country: India
facility: St.John's Hospital
state: Karnataka
city: Belgaum
country: India
facility: Belgaum Diabetes Centre
state: Karnataka
city: Mangalore
country: India
facility: Vinaya Hospital and Research Centre
state: Karnataka
city: Thrissur
country: India
facility: Kunnamkulam Eye and Diabetes Centre
state: Kerala
city: Pune
country: India
facility: OM Shree Swami Samarth Hospital
state: Maharashtra
city: Pune
country: India
facility: Patil Hospital
state: Maharashtra
city: Chennai
country: India
facility: MV Hospital for Diabetes Pvt Ltd
state: Tamil Nadu
city: Chennai
country: India
facility: Dr. V Seshiah Diabetes Research Institute
state: Tamil Nadu
city: Vellore
country: India
facility: Christian Medical College
state: Tamilnadu
city: Kolkata
country: India
facility: SK Diabetes Research & Education Center
state: West Bengal
city: Kolkata
country: India
facility: Advanced Medicare & Research Institute
Study officials:
References: