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

Diabetic Foot Ulcer Clinical Trial

— Truheal  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00926068
• Other study ID #: HO-09-01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 22, 2009
• Last updated: April 3, 2013
• Start date: February 2010

Study information

• Verified date: April 2013
• Source: HealOr
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 196
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Drug:
• HO/03/03 10µg

• Placebo

Locations

Country	Name	City	State
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	Belgaum	Karnataka
India	Dr. V Seshiah Diabetes Research Institute	Chennai	Tamil Nadu
India	MV Hospital for Diabetes Pvt Ltd	Chennai	Tamil Nadu
India	Medanta	Gurgaon	Haryana
India	Advanced Medicare & Research Institute	Kolkata
India	SK Diabetes Research & Education Center	Kolkata	West Bengal
India	Vinaya Hospital and Research Centre	Mangalore	Karnataka
India	OM Shree Swami Samarth Hospital	Pune	Maharashtra
India	Patil Hospital	Pune	Maharashtra
India	Kunnamkulam Eye and Diabetes Centre	Thrissur	Kerala
India	Christian Medical College	Vellore	Tamilnadu
United States	Bay Pines VA Healthcare System-Wound Clinic Bay Pines VA Healthcare System-Research Pharmacy	Bay Pines	Florida
United States	Cambridge Hospital	Cambridge	Massachusetts
United States	Center For Clinical Research	Castro Valley	California
United States	Deaconess Clinic Downtown-Research Institute	Evansville	Indiana
United States	St. Vincent Wound Care Center IDI Research	Indianapolis	Indiana
United States	Armstrong County Memorial Hospital Snyder Institute for Vascular Health and Research	Kittanning	Pennsylvania
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	Complete Family Foot Care	Mc Allen	Texas
United States	Doctors Research Network	Miami	Florida
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	North American Centre for Limb Preservation	New Haven	Connecticut
United States	Center for Curative & Palliative Wound Care Calvary Hospital	New York	New York
United States	Capt. James A. Lovell Federal Health Care Center	North Chicago	Illinois
United States	California School of Podiatric Medicine at Samuel Merritt University	Oakland	California
United States	Paddington Testing Company	Philadelphia	Pennsylvania
United States	Phoenix VA Healthcare System	Phoenix	Arizona
United States	Martin Foot and Ankle	York	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
HealOr	Cato Research, Clinigene International Ltd

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete ulcer closure	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.	Up to 14 weeks inclusive	No
Secondary	Percent change in wound area at 4 weeks		4 weeks	No
Secondary	75% wound closure by or on Study Week 14		Up to 14 weeks inclusive	No
Secondary	Incidence of adverse events, changes in vital signs, physical examination, electrocardiogram and laboratory tests from baseline to termination.		14 weeks	Yes
Secondary	Incidence of 100% Closure tested by the Fisher exact 2-tailed test		Up to 14 weeks inclusive	No
Secondary	Percent change in granulation tissue at 4 weeks		4 weeks	No
Secondary	Incidence of improved ulcers			No