Status:
UNKNOWN
Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers
Lead Sponsor:
HealOr
Collaborating Sponsors:
Clinigene International Ltd
Cato Research
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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:
- 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
- Subjects meeting one or more of the following criteria cannot be selected:
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT00926068
Start Date
February 1 2010
Last Update
April 4 2013
Active Locations (33)
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1
Phoenix VA Healthcare System
Phoenix, Arizona, United States, 85012
2
Center For Clinical Research
Castro Valley, California, United States, 94546
3
Dr. Ian Gordon
Long Beach, California, United States, 90822
4
Advanced Clinical Research
Los Angeles, California, United States, 90010