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

Foot Ulcer, Diabetic Clinical Trial

— APT-14-002  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356835
• Other study ID #: APT-14-002
• Status: Completed
• Phase: N/A
• First received: February 3, 2015
• Last updated: March 15, 2016
• Start date: February 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Advanced Plasma Therapies Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Intervention

Device:
• APT001
APT001, is a portable device that uses plasma energy to deliver nitric oxide to the tissues.
• SHAM
Portable device that uses warmed room air to mimic delivery of the APT001 treatment.

Locations

Country	Name	City	State
United States	Limb Preservation Platform, Inc.	Fresno	California
United States	Limb Preservation Platform, Inc.	Fresno	California
United States	Baptist Health Institute for Advanced Wound Care	Montgomery	Alabama
United States	New York College of Podiatric Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Plasma Therapies Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in bacterial load	Clearance of wound infection based on clinical observation and wound biopsy cultures.	Baseline to end of Week 5	Yes
Secondary	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	Yes