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

Origin Inc.10 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Foot Ulcer, Diabetic

Interventions

APT001DEVICE

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

Baptist Health Institute for Advanced Wound Care

Montgomery, Alabama, United States

Limb Preservation Platform, Inc.

Fresno, California, United States

Limb Preservation Platform, Inc.

Fresno, California, United States

New York College of Podiatric Medicine

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to end of Week 10

Secondary Outcomes

Change in bacterial load

Clearance of wound infection based on clinical observation and wound biopsy cultures.

Time frame: 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.

Time frame: Baseline to end of Week 10

Data from ClinicalTrials.gov

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