Diabetic Foot UlcerPhase 2TruhealNCT00926068
Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers
A Phase 2 study testing HO/03/03 10µg in people with Diabetic Foot Ulcer, run by HealOr at 33 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- HO/03/03 10µg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 33 sitesin 2 countries
- Study dates
- Feb 2010to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States19 sites
Bay Pines VA Healthcare System-Wound Clinic Bay Pines VA Healthcare System-Research Pharmacy
Bay Pines, Florida, 33744
Cambridge Hospital
Cambridge, Massachusetts, 02139
Center For Clinical Research
Castro Valley, California, 94546
Deaconess Clinic Downtown-Research Institute
Evansville, Indiana, 47713
St. Vincent Wound Care Center IDI Research
Indianapolis, Indiana, 46032
Armstrong County Memorial Hospital Snyder Institute for Vascular Health and Research
Kittanning, Pennsylvania, 16201
Dr. Ian Gordon
Long Beach, California, 90822
Advanced Clinical Research
Los Angeles, California, 90010
Innovative Medical Technologies, LLC
Los Angeles, California, 90063
Complete Family Foot Care
McAllen, Texas, 78501
University of Miami Miller School of Medicine
Miami, Florida, 33136
Doctors Research Network
Miami, Florida, 33143
North American Centre for Limb Preservation
New Haven, Connecticut, 06515
Center for Curative & Palliative Wound Care Calvary Hospital
New York, New York, 10461
Capt. James A. Lovell Federal Health Care Center
North Chicago, Illinois, 60064
California School of Podiatric Medicine at Samuel Merritt University
Oakland, California, 94609
Paddington Testing Company
Philadelphia, Pennsylvania, 19103
Phoenix VA Healthcare System
Phoenix, Arizona, 85012
Martin Foot and Ankle
York, Pennsylvania, 17403
India14 sites
Jain Institute of Vascular Sciences
Bangalore, Karnataka, 560052
Karnataka Institute of Diabetology
Bangalore, Karnataka, 560069
St.John's Hospital
Bangalore, Karnataka, 580034
Belgaum Diabetes Centre
Belagavi, Karnataka, 59001
MV Hospital for Diabetes Pvt Ltd
Chennai, Tamil Nadu, 600013
Dr. V Seshiah Diabetes Research Institute
Chennai, Tamil Nadu, 600029
Medanta
Gurgaon, Haryana, 122001
SK Diabetes Research & Education Center
Kolkata, West Bengal, 700009
Advanced Medicare & Research Institute
Kolkata
Vinaya Hospital and Research Centre
Mangalore, Karnataka, 575003
OM Shree Swami Samarth Hospital
Pune, Maharashtra, 411033
Patil Hospital
Pune, Maharashtra, 411051
Kunnamkulam Eye and Diabetes Centre
Thrissur, Kerala, 680 503
Christian Medical College
Vellore, Tamil Nadu, 632004
About this study
Official title: Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers (Truheal)
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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- HO/03/03 10µg, Placebo
- Keywords
- Diabetes Mellitus, Foot Ulcer, DFU, Wound healing
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HO/03/03 10µgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| HO/03/03 10µg | Experimental | Not described Receives: Drug: HO/03/03 10µg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 weeks inclusive
Secondary outcomes (6)
Percent change in wound area at 4 weeks
Measured: 4 weeks
75% wound closure by or on Study Week 14
Measured: Up to 14 weeks inclusive
Incidence of adverse events, changes in vital signs, physical examination, electrocardiogram and laboratory tests from baseline to termination.
Measured: 14 weeks
Incidence of 100% Closure tested by the Fisher exact 2-tailed test
Measured: Up to 14 weeks inclusive
Percent change in granulation tissue at 4 weeks
Measured: 4 weeks
Incidence of improved ulcers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startFeb 2010
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealOr
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinigene International Ltd, Cato Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926068
- Sponsor's protocol ID
- HO-09-01
- Acronym
- Truheal
- Status last verified
- Apr 2013
- First submitted
- 22 Jun 2009
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of HO/03/03 10μg in the Treatment of Plantar Neuropathic Diabetic Foot Ulcers (Truheal)
- ClinicalTrials.gov ID
- NCT00926068
- Acronym / sponsor ID
- Truheal / HO-09-01
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes Mellitus, Foot Ulcer, DFU, Wound healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- HealOrIndustry (pharma, biotech, devices)
- Collaborators
- Clinigene International Ltd, Cato Research
- Study start
- Feb 2010
- Primary completion
- Aug 2013 (estimated)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HO/03/03 10µg | Experimental | Drug: HO/03/03 10µg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- Single target, ulcer on the study foot:
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HO/03/03 10µg | Drug | HO/03/03 10µg |
| Placebo | Drug | Placebo |
Primary outcome
Complete ulcer closure
Time frame: Up to 14 weeks inclusive
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.
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HO/03/03 10µg in people with Diabetic Foot Ulcer, run by HealOr at 33 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ulcer closure (time frame: Up to 14 weeks inclusive). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.