Foot Ulcer, DiabeticAPT-14-002NCT02356835
APT001 Plasma/NO Generator to Treat Diabetic Foot Ulcer in Adults
A study testing APT001 in people with Foot Ulcer, Diabetic, run by Origin Inc. at 4 sites in United States.
Trial summary
This is a 10-week, randomized, controlled study to evaluate the efficacy and safety of the APT001 plasma and nitric oxide treatment in subjects with a diabetic foot ulcer. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- APT001
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2015to Mar 2016
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 to 80 years of age
- Type 1 or 2 diabetes with hemoglobin A1c less than 12%
- ABI ≥ 0.7, palpable pulses and/or biphasic waveform study with Doppler
- Wound size ≥ 1cm2 and ≤ 30cm2 (the first 10 patients enrolled will be limited to a wound size of 7 cm2 or less)
Who cannot join
- Have a significant concomitant illness that would adversely affect participation in the study or affect the healing of the wound
- Have a severe infection in the ulcer including the presence of an abscess, cellulitis extending > 2 cm beyond the ulcer margin, or osteomyelitis
- Have involvement of deeper tissues including bone or tendon
- Be currently receiving steroid medications, chemotherapy, or other medications that might affect healing of the wound
- Have received topical or systemic antimicrobial therapy within 48 hours of screening
- Have a malignancy other than skin cancer currently being treated
Show all 10Show fewer
- Have substance abuse issues within the 6 months prior to screening
- Is a woman who is pregnant or breast feeding
- Has been treated with another investigational product within 30 days of screening
- Has been treated with tissue engineered skin or a biological therapy within 30 days of screening
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Limb Preservation Platform, Inc.
Fresno, California, 93720
Limb Preservation Platform, Inc.
Fresno, California, 93721
Baptist Health Institute for Advanced Wound Care
Montgomery, Alabama, 36111
New York College of Podiatric Medicine
New York, New York, 10035
About this study
Official title: A Pivotal Study of the Use of Nitric Oxide / Plasma Therapy as Produced by the APT001 Plasma / Nitric Oxide Generator in Adult Subjects With a Diabetic Foot Ulcer
This is a 10-week, randomized, controlled study to evaluate the efficacy and safety of the APT001 plasma and nitric oxide treatment in subjects with a diabetic foot ulcer.
Read the detailed description
Approximately 80 subjects will be randomized by computer to receive equally either sham therapy or plasma / nitric oxide treatments topically. The nitric oxide / plasma treatment will be delivered from 11.5 to 15 centimeters from the wound surface for 10 seconds per cm2 of wound size. Subjects will be evaluated for efficacy and safety on a regular basis with clinical observations. The wounds of both groups will be treated with sharp debridement as determined by the site Investigator. A collagen dressing, a non-adherent dressing, and an absorptive dressing will be applied to the wound after either the study therapy or the sham therapy.
For an initial safety evaluation in patients with DFU, the first ten patients randomized will be limited to wound size of 7 cm2 or less and their wounds will be assessed 2-4 days after each treatment session. Following completion of the final assessment in these 10 patients, data will be submitted to FDA for review and approval before opening the enrolment for the remaining patients.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- APT001, SHAM
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APT001Device
Also called APT001 Plasma/Nitric Oxide
APT001, is a portable device that uses plasma energy to deliver nitric oxide to the tissues.
SHAMDevice
Portable device that uses warmed room air to mimic delivery of the APT001 treatment.
| Study group | Role | What they receive |
|---|---|---|
| APT001 | Experimental | The APT001 is a medical device that generates a plasma flow containing nitric oxide intended to be applied topically to wound sites. The nitric oxide / plasma flow will be directed at the wound site and surrounding skin at a distance of 11.5 to 15 centimeters from the skin surface. Dose will be 10 seconds / cm2 wound surface area. Administration of the therapy will include a 2 cm border around the defined edges of the wound site. Receives: Device: APT001 |
| SHAM | Sham comparator | Treatment with a sham device to deliver non-medicated, heated room air to the wound in the same manner and dose as the active treatment device. Receives: Device: SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in total wound size
Change in total wound size using dimensional measurements of the wound and using the Aranz SilhouetteStar + SilhouetteConnect wound assessment device from Baseline to Week 10.
Measured: Baseline to end of Week 10
Secondary outcomes (2)
Change in bacterial load
Clearance of wound infection based on clinical observation and wound biopsy cultures.
Measured: Baseline to end of Week 5
Wound pain
Wound pain measured by a standard wound pain scale completed at each visit prior to treatment or any study procedures.
Measured: Baseline to end of Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Origin Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David R Dantzker, MD, Study director, Origin Inc.Terry A Treadwell, MD, Principal investigator, Institute for Advanced Wound Care Baptist Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356835
- Sponsor's protocol ID
- APT-14-002
- Acronym
- APT-14-002
- Status last verified
- Mar 2016
- First submitted
- 3 Feb 2015
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study of the Use of Nitric Oxide / Plasma Therapy as Produced by the APT001 Plasma / Nitric Oxide Generator in Adult Subjects With a Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT02356835
- Acronym / sponsor ID
- APT-14-002 / APT-14-002
- Conditions
- Foot Ulcer, Diabetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Origin Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Feb 2015 (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.
This is a 10-week, randomized, controlled study to evaluate the efficacy and safety of the APT001 plasma and nitric oxide treatment in subjects with a diabetic foot ulcer.
Detailed description
Approximately 80 subjects will be randomized by computer to receive equally either sham therapy or plasma / nitric oxide treatments topically. The nitric oxide / plasma treatment will be delivered from 11.5 to 15 centimeters from the wound surface for 10 seconds per cm2 of wound size. Subjects will be evaluated for efficacy and safety on a regular basis with clinical observations. The wounds of both groups will be treated with sharp debridement as determined by the site Investigator. A collagen dressing, a non-adherent dressing, and an absorptive dressing will be applied to the wound after either the study therapy or the sham therapy.
For an initial safety evaluation in patients with DFU, the first ten patients randomized will be limited to wound size of 7 cm2 or less and their wounds will be assessed 2-4 days after each treatment session. Following completion of the final assessment in these 10 patients, data will be submitted to FDA for review and approval before opening the enrolment for the remaining patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APT001 | Experimental | Device: APT001The APT001 is a medical device that generates a plasma flow containing nitric oxide intended to be applied topically to wound sites. The nitric oxide / plasma flow will be directed at the wound site and surrounding skin at a distance of 11.5 to 15 centimeters from the skin surface. Dose will be 10 seconds / cm2 wound surface area. Administration of the therapy will include a 2 cm border around the defined edges of the wound site. |
| SHAM | Sham comparator | Device: SHAMTreatment with a sham device to deliver non-medicated, heated room air to the wound in the same manner and dose as the active treatment device. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 19 to 80 years of age
- Type 1 or 2 diabetes with hemoglobin A1c less than 12%
- ABI ≥ 0.7, palpable pulses and/or biphasic waveform study with Doppler
- Wound size ≥ 1cm2 and ≤ 30cm2 (the first 10 patients enrolled will be limited to a wound size of 7 cm2 or less)
Key exclusion criteria (10 listed)
- Have a significant concomitant illness that would adversely affect participation in the study or affect the healing of the wound
- Have a severe infection in the ulcer including the presence of an abscess, cellulitis extending > 2 cm beyond the ulcer margin, or osteomyelitis
- Have involvement of deeper tissues including bone or tendon
- Be currently receiving steroid medications, chemotherapy, or other medications that might affect healing of the wound
- Have received topical or systemic antimicrobial therapy within 48 hours of screening
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 |
|---|---|---|
| APT001Also: APT001 Plasma/Nitric OxideAPT001, is a portable device that uses plasma energy to deliver nitric oxide to the tissues. | Device | APT001 |
| SHAMPortable device that uses warmed room air to mimic delivery of the APT001 treatment. | Device | SHAM |
Primary outcome
Percent change in total wound size
Time frame: Baseline to end of Week 10
Change in total wound size using dimensional measurements of the wound and using the Aranz SilhouetteStar + SilhouetteConnect wound assessment device from Baseline to Week 10.
2 secondary outcomes
Change in bacterial load
Time frame: Baseline to end of Week 5
Wound pain
Time frame: Baseline to end of Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
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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 R Dantzker, MD study director
Origin Inc.
Terry A Treadwell, MD principal investigator
Institute for Advanced Wound Care Baptist Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APT001 in people with Foot Ulcer, Diabetic, run by Origin Inc. at 4 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 4 inclusion and 10 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 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent change in total wound size (time frame: Baseline to end of Week 10). 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 17 Mar 2016.