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APT001 Plasma/NO Generator to Treat Diabetic Foot Ulcer in Adults (APT-14-002)

Primary Purpose

Foot Ulcer, Diabetic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
APT001
SHAM
Sponsored by
Origin Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Ulcer, Diabetic

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist Health Institute for Advanced Wound Care
  • Limb Preservation Platform, Inc.
  • Limb Preservation Platform, Inc.
  • New York College of Podiatric Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

APT001

SHAM

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in bacterial load
Clearance of wound infection based on clinical observation and wound biopsy cultures.
Wound pain
Wound pain measured by a standard wound pain scale completed at each visit prior to treatment or any study procedures.

Full Information

First Posted
February 3, 2015
Last Updated
March 15, 2016
Sponsor
Origin Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02356835
Brief Title
APT001 Plasma/NO Generator to Treat Diabetic Foot Ulcer in Adults
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Origin Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APT001
Arm Type
Experimental
Arm Description
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.
Arm Title
SHAM
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
APT001
Other Intervention Name(s)
APT001 Plasma/Nitric Oxide
Intervention Description
APT001, is a portable device that uses plasma energy to deliver nitric oxide to the tissues.
Intervention Type
Device
Intervention Name(s)
SHAM
Intervention Description
Portable device that uses warmed room air to mimic delivery of the APT001 treatment.
Primary Outcome Measure Information:
Title
Percent change in total wound size
Description
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 Outcome Measure Information:
Title
Change in bacterial load
Description
Clearance of wound infection based on clinical observation and wound biopsy cultures.
Time Frame
Baseline to end of Week 5
Title
Wound pain
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Dantzker, MD
Organizational Affiliation
Origin Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Terry A Treadwell, MD
Organizational Affiliation
Institute for Advanced Wound Care Baptist Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Health Institute for Advanced Wound Care
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
Facility Name
Limb Preservation Platform, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Limb Preservation Platform, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
New York College of Podiatric Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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