APT001 Plasma/NO Generator to Treat Diabetic Foot Ulcer in Adults (APT-14-002)
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|ClinicalTrials.gov Identifier: NCT02356835|
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : March 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Foot Ulcer, Diabetic||Device: APT001 Device: SHAM||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 2016|
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.
APT001, is a portable device that uses plasma energy to deliver nitric oxide to the tissues.
Other Name: APT001 Plasma/Nitric Oxide
Sham Comparator: SHAM
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.
Portable device that uses warmed room air to mimic delivery of the APT001 treatment.
- 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.
- Change in bacterial load [ Time Frame: Baseline to end of Week 5 ]Clearance of wound infection based on clinical observation and wound biopsy cultures.
- Wound pain [ Time Frame: Baseline to end of Week 10 ]Wound pain measured by a standard wound pain scale completed at each visit prior to treatment or any study procedures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356835
|United States, Alabama|
|Baptist Health Institute for Advanced Wound Care|
|Montgomery, Alabama, United States, 36111|
|United States, California|
|Limb Preservation Platform, Inc.|
|Fresno, California, United States, 93720|
|Limb Preservation Platform, Inc.|
|Fresno, California, United States, 93721|
|United States, New York|
|New York College of Podiatric Medicine|
|New York, New York, United States, 10035|
|Study Director:||David R Dantzker, MD||Advanced Plasma Therapies Inc|
|Principal Investigator:||Terry A Treadwell, MD||Institute for Advanced Wound Care Baptist Health|