APT001 Plasma/NO Generator to Treat Diabetic Foot Ulcer in Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Foot Ulcer, Diabetic

Intervention / Treatment
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* Device: APT001
* Device: SHAM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APT001<br>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. | Device: APT001<br>* APT001, is a portable device that uses plasma energy to deliver nitric oxide to the tissues.<br>* Other names: APT001 Plasma/Nitric Oxide;|
| Sham Comparator: SHAM<br>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. | Device: SHAM<br>* Portable device that uses warmed room air to mimic delivery of the APT001 treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to end of Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bacterial load | Clearance of wound infection based on clinical observation and wound biopsy cultures. | 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. | Baseline to end of Week 10 |