Diabetic Foot UlcerNCT03078933
A Feasibility Study of Advance Plasma Therapy001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
A study of Diabetic Foot Ulcer, run by Origin Inc. at 15 sites in United States.
Trial summary
The clinical trial will assess the delivery of Nitric Oxide topically to the diabetic foot ulcer wound and the surrounding wound area as it related to wound healing. The objective of the study is to assess the Nitric Oxide Therapy treatment time (the number of minutes to deliver the treatment) and frequency (number of… Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Diabetic Foot Ulcer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 15 sitesUnited States
- Study dates
- 20 Mar 2017to Jul 2018
- Phase
- Interventional
- 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 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes Type 1 or Type 2
- Wound size greater than or equal to 1 cm2 and less than or equal to 16 cm2
- HbA1c less than or equal to 12 %
- Single full thickness DFU on the plantar aspect of toes or foot
- Ankle Brachial Index greater than or equal to 0.7
Who cannot join
- Infection of the ulcer
- Active Charcot's disease
- wound involves deeper tissues including bone or tendon
- Negative pressure therapy on affected foot or Hyperbaric Oxygen Therapy
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
Clinical Site
Boston, Massachusetts, 02118
- Recruiting
Clinical Site
Cooper City, Florida, 33024
- Recruiting
Clinical Site
Corpus Christi, Texas, 78401
- Recruiting
Clinical Site
Fresno, California, 93721
- Recruiting
Clinical Site
Los Angeles, California, 90001
- Recruiting
Clinical Site
Miami, Florida, 33031'
- Recruiting
Clinical Site
Miami, Florida, 33032
- Recruiting
Clinical Site
Montgomery, Alabama, 36111
- Recruiting
Clinical Site
Phoenix, Arizona, 85015
- Recruiting
Clinical Site
San Antonio, Texas, 78229
- Recruiting
Clinical Site
San Francisco, California, 94115
- Recruiting
Clinical Site
Sylmar, California, 91342
- Recruiting
Clinical Site
Tucson, Arizona, 85634
- Recruiting
Clinical Site
Webster, Texas, 78245
- Recruiting
Clinical Site
West Columbia, South Carolina, 29033
About this study
Official title: A Randomized, Prospective, Multi-Center Feasibility Study of APT001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
The clinical trial will assess the delivery of Nitric Oxide topically to the diabetic foot ulcer wound and the surrounding wound area as it related to wound healing.
The objective of the study is to assess the Nitric Oxide Therapy treatment time (the number of minutes to deliver the treatment) and frequency (number of days per week to treat) to determine the most optimal treatment time and frequency to develop a rationale for safety and efficacy for the final APT001 clinical study.
Read the detailed description
APT001 is a medical device that generates nitric oxide (NO) from ambient room air within a defined plasma stream. This study is a randomized, prospective, multi-center feasibility study that will assess the effect of Nitric Oxide treatment time (minutes) and frequency (days/week) on wound healing in adults with diabetic foot ulcers (DFUs) and to provide information that will be used to develop final safety and effectiveness hypotheses for a pivotal trial of the APT001 device.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Standard of Care, Nitric Oxide Therapy 2x week 6 min. plus standard of care, Nitric Oxide Therapy 2x week 12 min. plus standard of care, Nitric Oxide Therapy 4x week 6 min. plus standard of care, Nitric Oxide Therapy 4x week 12 min. plus standard of care
- Keywords
- DFU
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareDevice
Standard of Care arm which includes wound care, dressings and debridement.
Nitric Oxide Therapy 2x week 6 min. plus standard of careDevice
Active Therapy Nitric Oxide delivered topically to the wound twice a week for 6 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
Nitric Oxide Therapy 2x week 12 min. plus standard of careDevice
Active Therapy Nitric Oxide delivered topically to the wound twice a week for 12 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
Nitric Oxide Therapy 4x week 6 min. plus standard of careDevice
Active Therapy Nitric Oxide delivered topically to the wound four times a week for 6 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
Nitric Oxide Therapy 4x week 12 min. plus standard of careDevice
Active Therapy Nitric Oxide delivered topically to the wound four times a week for 12 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of care for diabetic foot ulcer wound care Receives: Device: Standard of Care |
| APT001NitricOxide tx 2x week 6 min+ SOC | Experimental | APT001 Nitric OxideTherapy 2x week for 6 min. treatment time plus standard of care Receives: Device: Nitric Oxide Therapy 2x week 6 min. plus standard of care |
| APT001Nitric Oxide tx 2x week 12 min+SOC | Experimental | APT001Nitric Oxide Therapy 2x week for 12 min. treatment time plus standard of care Receives: Device: Nitric Oxide Therapy 2x week 12 min. plus standard of care |
| APT001Nitric Oxide tx 4x week 6 min+SOC | Experimental | APT001 Nitric Oxide Therapy 4x week for 6 min. treatment time plus standard of care Receives: Device: Nitric Oxide Therapy 4x week 6 min. plus standard of care |
| APT001Nitric Oxide tx 4x week 12 min+SOC | Experimental | APT001Nitric Oxide Therapy 4x week for 12 min. treatment time plus standard of care Receives: Device: Nitric Oxide Therapy 4x week 12 min. plus standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure rate
cm2 of epithelium coverage per week
Measured: 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start20 Mar 2017
- Primary completionMay 2018 (estimated)
- Study completionJul 2018 (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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Two or more interventions, each alone and in combination, are evaluated in parallel against a control group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Origin Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Dantzker, MD, Study chair, Origin Inc.Terry Treadwell, MD, Principal investigator, Institute for Advanced Wound Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078933
- Sponsor's protocol ID
- ORI-16-003
- Status last verified
- Jun 2017
- First submitted
- 28 Feb 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Multi-Center Feasibility Study of APT001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03078933
- Acronym / sponsor ID
- ORI-16-003
- Conditions
- Diabetic Foot Ulcer
- Keywords
- DFU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Origin Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 14 Mar 2017 (actual)
- 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.
The clinical trial will assess the delivery of Nitric Oxide topically to the diabetic foot ulcer wound and the surrounding wound area as it related to wound healing.
The objective of the study is to assess the Nitric Oxide Therapy treatment time (the number of minutes to deliver the treatment) and frequency (number of days per week to treat) to determine the most optimal treatment time and frequency to develop a rationale for safety and efficacy for the final APT001 clinical study.
Detailed description
APT001 is a medical device that generates nitric oxide (NO) from ambient room air within a defined plasma stream. This study is a randomized, prospective, multi-center feasibility study that will assess the effect of Nitric Oxide treatment time (minutes) and frequency (days/week) on wound healing in adults with diabetic foot ulcers (DFUs) and to provide information that will be used to develop final safety and effectiveness hypotheses for a pivotal trial of the APT001 device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 5
- Model description
- Two or more interventions, each alone and in combination, are evaluated in parallel against a control group
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Device: Standard of CareStandard of care for diabetic foot ulcer wound care |
| APT001NitricOxide tx 2x week 6 min+ SOC | Experimental | Device: Nitric Oxide Therapy 2x week 6 min. plus standard of careAPT001 Nitric OxideTherapy 2x week for 6 min. treatment time plus standard of care |
| APT001Nitric Oxide tx 2x week 12 min+SOC | Experimental | Device: Nitric Oxide Therapy 2x week 12 min. plus standard of careAPT001Nitric Oxide Therapy 2x week for 12 min. treatment time plus standard of care |
| APT001Nitric Oxide tx 4x week 6 min+SOC | Experimental | Device: Nitric Oxide Therapy 4x week 6 min. plus standard of careAPT001 Nitric Oxide Therapy 4x week for 6 min. treatment time plus standard of care |
| APT001Nitric Oxide tx 4x week 12 min+SOC | Experimental | Device: Nitric Oxide Therapy 4x week 12 min. plus standard of careAPT001Nitric Oxide Therapy 4x week for 12 min. treatment time plus standard of care |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetes Type 1 or Type 2
- Wound size greater than or equal to 1 cm2 and less than or equal to 16 cm2
- HbA1c less than or equal to 12 %
- Single full thickness DFU on the plantar aspect of toes or foot
- Ankle Brachial Index greater than or equal to 0.7
Key exclusion criteria (4 listed)
- Infection of the ulcer
- Active Charcot's disease
- wound involves deeper tissues including bone or tendon
- Negative pressure therapy on affected foot or Hyperbaric Oxygen Therapy
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 |
|---|---|---|
| Standard of CareStandard of Care arm which includes wound care, dressings and debridement. | Device | Standard of Care |
| Nitric Oxide Therapy 2x week 6 min. plus standard of careActive Therapy Nitric Oxide delivered topically to the wound twice a week for 6 minutes plus standard of care. Standard of care includes wound care, dressings and debridement. | Device | APT001NitricOxide tx 2x week 6 min+ SOC |
| Nitric Oxide Therapy 2x week 12 min. plus standard of careActive Therapy Nitric Oxide delivered topically to the wound twice a week for 12 minutes plus standard of care. Standard of care includes wound care, dressings and debridement. | Device | APT001Nitric Oxide tx 2x week 12 min+SOC |
| Nitric Oxide Therapy 4x week 6 min. plus standard of careActive Therapy Nitric Oxide delivered topically to the wound four times a week for 6 minutes plus standard of care. Standard of care includes wound care, dressings and debridement. | Device | APT001Nitric Oxide tx 4x week 6 min+SOC |
| Nitric Oxide Therapy 4x week 12 min. plus standard of careActive Therapy Nitric Oxide delivered topically to the wound four times a week for 12 minutes plus standard of care. Standard of care includes wound care, dressings and debridement. | Device | APT001Nitric Oxide tx 4x week 12 min+SOC |
Primary outcome
Wound Closure rate
Time frame: 12 weeks of treatment
cm2 of epithelium coverage per week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Foot Ulcer
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PAW-Hydrogel for Chronic Wound Healing
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
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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.
David Dantzker, MD study chair
Origin Inc.
Terry Treadwell, MD principal investigator
Institute for Advanced Wound Care
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetic Foot Ulcer, run by Origin Inc. at 15 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 5 inclusion and 4 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 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Katherine M Tranotti, BSN/MBA (6092506000 ext. 6006, ktranotti@originww.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Closure rate (time frame: 12 weeks of treatment). 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 7 Jun 2017.