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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID: NCT00926068
Run by: HealOr
People needed: 196
Starts: 2010-02-01
Last updated by the study team: 2013-04-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Phoenix VA Healthcare System — Phoenix, Arizona, United States
Center For Clinical Research — Castro Valley, California, United States
Dr. Ian Gordon — Long Beach, California, United States
Advanced Clinical Research — Los Angeles, California, United States
Innovative Medical Technologies, LLC — Los Angeles, California, United States
California School of Podiatric Medicine at Samuel Merritt University — Oakland, California, United States
North American Centre for Limb Preservation — New Haven, Connecticut, United States
Bay Pines VA Healthcare System-Wound Clinic Bay Pines VA Healthcare System-Research Pharmacy — Bay Pines, Florida, United States
University of Miami Miller School of Medicine — Miami, Florida, United States
Doctors Research Network — Miami, Florida, United States
Capt. James A. Lovell Federal Health Care Center — North Chicago, Illinois, United States
Deaconess Clinic Downtown-Research Institute — Evansville, Indiana, United States
St. Vincent Wound Care Center IDI Research — Indianapolis, Indiana, United States
Cambridge Hospital — Cambridge, Massachusetts, United States
Center for Curative & Palliative Wound Care Calvary Hospital — New York, New York, United States
Armstrong County Memorial Hospital Snyder Institute for Vascular Health and Research — Kittanning, Pennsylvania, United States
Paddington Testing Company — Philadelphia, Pennsylvania, United States
Martin Foot and Ankle — York, Pennsylvania, United States
Complete Family Foot Care — McAllen, Texas, United States
Medanta — Gurgaon, Haryana, India
Jain Institute of Vascular Sciences — Bangalore, Karnataka, India
Karnataka Institute of Diabetology — Bangalore, Karnataka, India
St.John's Hospital — Bangalore, Karnataka, India
Belgaum Diabetes Centre — Belagavi, Karnataka, India
Vinaya Hospital and Research Centre — Mangalore, Karnataka, India

Full record on ClinicalTrials.gov

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