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

NCT ID: NCT02356835

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-03-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

APT001

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.

Group Type: EXPERIMENTAL

APT001

Intervention Type: DEVICE

APT001, is a portable device that uses plasma energy to deliver nitric oxide to the tissues.

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.

Group Type: SHAM_COMPARATOR

SHAM

Intervention Type: DEVICE

Portable device that uses warmed room air to mimic delivery of the APT001 treatment.

Interventions

APT001

APT001, is a portable device that uses plasma energy to deliver nitric oxide to the tissues.

Intervention Type: DEVICE

SHAM

Portable device that uses warmed room air to mimic delivery of the APT001 treatment.

Intervention Type: DEVICE

Other Intervention Names

APT001 Plasma/Nitric Oxide

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Origin Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David R Dantzker, MD

Role: STUDY_DIRECTOR

Origin Inc.

Terry A Treadwell, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Advanced Wound Care Baptist Health

Locations

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

Countries

United States

Other Identifiers

APT-14-002

Identifier Type: -

Identifier Source: org_study_id