Diabetic Foot UlcersPhase 2/3NCT01291160
Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers
A Phase 2/3 study testing Epiflo and Moist Wound Therapy in people with Diabetic Foot Ulcers, run by Neogenix, LLC dba Ogenix at 14 sites in United States.
Trial summary
This is a multicenter, prospective, parallel, double-blinded, validation study of up to 12 weeks duration to evaluate the safety and effectiveness of EPIFLO for the treatment of Diabetic Foot Ulcer. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Epiflo and Moist Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 14 sitesUnited States
- Study dates
- Oct 2009to Feb 2013
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 20-90 years of age with type 1 or type 2 diabetes mellitus with non-healing, full-thickness, University of Texas Classification of Diabetic Foot Ulcers Class IA diabetic foot ulcers of at least 4 weeks duration, but not greater than 52 weeks, measuring 1 -10 cm2 in area (Area = length x width) 50% at least from 65+ age group
- Any diabetic foot ulcer at or below the malleoli
- Patients with partial amputation up to \& including a TMA
- Subjects; between 20-90 years of age with a diabetic foot ulcer; 50% at least from 65+ age group
- Subjects must have had the wound open for at least 4 weeks from day one on screening visit.
- Subjects wound must be ≥1 cm2 in size at screening visit, but not greater than 10 cm2.
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- Subject's ABI should be ≥ 0.7 on the study limb or transcutaneous partial pressure oxygen (TcpO2) >40mmHg; or a toe pressure ≥40mmHg; or a Doppler waveform consistent with adequate flow in the foot(biphasic or triphasic waveforms) at screening
- No active malignancy except non-melanoma skin cancer
- Subject and/or caregiver must be willing and able to learn and perform the duties of dressing changes, and demonstrate the ability to do so.
- If patient has had a history of alcohol or substance abuse within 6 months prior to base line period, should provide proof of treatment.
Who cannot join
- Wounds of duration >52 weeks
- Evidence of gangrene on any part of affected limb;
- Subjects with active Charcot's foot on the study limb;
- Subjects scheduled to undergo vascular surgery, angioplasty or thrombolysis;
- Subjects with infected target ulcers, accompanied by cellulitis, known or suspected osteomyelitis, or other clinical evidence of infection;
- Index ulcer has exposed tendons, ligaments, muscle, or bone.
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- ulcers present in between toes
- Target limb is infected at beginning of study
- Must never have had malignancy on study limb
- Oral, or IV antibiotic/antimicrobial agents or medications have been used within 2 days (48 hours) of baseline.
- Patients with steroids >7mg dosage are excluded
- Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening date.
- Subject may not be pregnant at the time of treatment.
- Subjects with ulcer that has a total Surface Area of greater than 10 cm2 at Screening Visit as measured by a member of the study staff;
- Subject is undergoing renal dialysis, has known immune insufficiency, other than Diabetes Mellitus
- Ulcers which decrease in area by >30% during the screening 1-week run-in period
- History of peripheral vascular repair within the 30 days of baseline.
- Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
- No known "patient-reported" alcohol or substance abuse within three months prior to baseline.
- Subject currently enrolled or participated within 30 days of baseline in another investigational device, drug or biological trial.
- Subject allergic to a broad spectrum of primary \& secondary dressing materials,including occlusive dressings and the adhesives on such dressings.
- Subject with Chopart amputation
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Boston Medical Center
Boston, Massachusetts, 02118
Dean Vayser, DPM
Encinitas, California, 92024
California School of Podiatric Medicine
Fresno, California, 93719
Ohio College of Podiatric Medicine
Independence, Ohio, 44131
UF College of Medicine-Jacksonville
Jacksonville, Florida, 32209
Study site
Los Angeles, California, 90010
Bruce W. Carter Dept. of Veterans Affairs Medical Center, Miami VA Health Care System
Miami, Florida, 33125
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012
Study site
San Antonio, Texas, 78212
Study site
San Jose, California, 95116
The Diabetic Foot
San Marcos, California, 92078-2427
Tacoma Diabetic Foot Center
Tacoma, Washington, 98405
Ocean County Foot & Ankle Surgical Associates
Toms River, New Jersey, 08753
Southern AZ VA Health Care System
Tucson, Arizona, 85723
About this study
Official title: A Prospective, Randomized Blinded Multicenter, Parallel Study Comparing Transdermal, Continuous Oxygen Delivery to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers
This is a multicenter, prospective, parallel, double-blinded, validation study of up to 12 weeks duration to evaluate the safety and effectiveness of EPIFLO for the treatment of Diabetic Foot Ulcer. The primary objectives of this study are: 1) to evaluate the effectiveness of EPIFLO in combination with standard wound therapy on wound healing as compared to standard wound therapy alone; and 2) Screening for potential safety issues.
Diabetic subjects with a Diabetic Foot Ulcer present for a minimum of 30 days will be enrolled. All subjects enrolled in the study will receive a standard wound therapy regimen consisting of, wound cleansing, moist wound care, off-loading and as appropriate, aggressive debridement. Subjects will be randomized to either the Treatment arm or the Control arm. Subjects will be assessed weekly for signs of wound healing during the 12-week Treatment Period, once two weeks after wound closure and once at the end of 12-week durability Period.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Epiflo, Moist Wound Therapy
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpifloDevice
Also called Transdermal Continuous Oxygen Therapy
During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
Moist Wound TherapyOther
During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Epiflo Treatment | Experimental | The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period. Receives: Device: Epiflo |
| Sham Device | Sham comparator | The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period. Receives: Other: Moist Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of 100% Wound Closure
Measured: before or at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startOct 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot UlcersStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neogenix, LLC dba Ogenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vickie R Driver, MSDPM FACFAS, Principal investigator, Lead Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291160
- Sponsor's protocol ID
- EPF-409
- Status last verified
- Apr 2014
- First submitted
- 4 Feb 2011
- Last updated
- 13 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Blinded Multicenter, Parallel Study Comparing Transdermal, Continuous Oxygen Delivery to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01291160
- Acronym / sponsor ID
- EPF-409
- Conditions
- Diabetic Foot Ulcers
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Neogenix, LLC dba OgenixIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Posted 13 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, prospective, parallel, double-blinded, validation study of up to 12 weeks duration to evaluate the safety and effectiveness of EPIFLO for the treatment of Diabetic Foot Ulcer. The primary objectives of this study are: 1) to evaluate the effectiveness of EPIFLO in combination with standard wound therapy on wound healing as compared to standard wound therapy alone; and 2) Screening for potential safety issues.
Diabetic subjects with a Diabetic Foot Ulcer present for a minimum of 30 days will be enrolled. All subjects enrolled in the study will receive a standard wound therapy regimen consisting of, wound cleansing, moist wound care, off-loading and as appropriate, aggressive debridement. Subjects will be randomized to either the Treatment arm or the Control arm. Subjects will be assessed weekly for signs of wound healing during the 12-week Treatment Period, once two weeks after wound closure and once at the end of 12-week durability Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epiflo Treatment | Experimental | Device: EpifloThe cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period. |
| Sham Device | Sham comparator | Other: Moist Wound TherapyThe cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female patients 20-90 years of age with type 1 or type 2 diabetes mellitus with non-healing, full-thickness, University of Texas Classification of Diabetic Foot Ulcers Class IA diabetic foot ulcers of at least 4 weeks duration, but not greater than 52 weeks, measuring 1 -10 cm2 in area (Area = length x width) 50% at least from 65+ age group
- Any diabetic foot ulcer at or below the malleoli
- Patients with partial amputation up to \& including a TMA
- Subjects; between 20-90 years of age with a diabetic foot ulcer; 50% at least from 65+ age group
- Subjects must have had the wound open for at least 4 weeks from day one on screening visit.
Key exclusion criteria (22 listed)
- Wounds of duration >52 weeks
- Evidence of gangrene on any part of affected limb;
- Subjects with active Charcot's foot on the study limb;
- Subjects scheduled to undergo vascular surgery, angioplasty or thrombolysis;
- Subjects with infected target ulcers, accompanied by cellulitis, known or suspected osteomyelitis, or other clinical evidence of infection;
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 |
|---|---|---|
| EpifloAlso: Transdermal Continuous Oxygen TherapyDuring the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first. | Device | Epiflo Treatment |
| Moist Wound TherapyDuring the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first. | Other | Sham Device |
Primary outcome
Number of 100% Wound Closure
Time frame: before or at week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
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Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
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Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
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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.
Vickie R Driver, MSDPM FACFAS principal investigator
Lead Principal Investigator
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Epiflo and Moist Wound Therapy in people with Diabetic Foot Ulcers, run by Neogenix, LLC dba Ogenix at 14 sites in United States.
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 10 inclusion and 22 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: finished, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of 100% Wound Closure (time frame: before or at week 12). 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 13 May 2014.