A Feasibility Study of Advance Plasma Therapy001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
A Randomized, Prospective, Multi-Center Feasibility Study of APT001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
1 other identifier
interventional
100
1 country
15
Brief Summary
The clinical trial will assess the delivery of Nitric Oxide topically to the diabetic foot ulcer wound and the surrounding wound area as it related to wound healing. The objective of the study is to assess the Nitric Oxide Therapy treatment time (the number of minutes to deliver the treatment) and frequency (number of days per week to treat) to determine the most optimal treatment time and frequency to develop a rationale for safety and efficacy for the final APT001 clinical study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 14, 2017
CompletedStudy Start
First participant enrolled
March 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJune 7, 2017
June 1, 2017
1.1 years
February 28, 2017
June 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound Closure rate
cm2 of epithelium coverage per week
12 weeks of treatment
Study Arms (5)
Standard of Care
ACTIVE COMPARATORStandard of care for diabetic foot ulcer wound care
APT001NitricOxide tx 2x week 6 min+ SOC
EXPERIMENTALAPT001 Nitric OxideTherapy 2x week for 6 min. treatment time plus standard of care
APT001Nitric Oxide tx 2x week 12 min+SOC
EXPERIMENTALAPT001Nitric Oxide Therapy 2x week for 12 min. treatment time plus standard of care
APT001Nitric Oxide tx 4x week 6 min+SOC
EXPERIMENTALAPT001 Nitric Oxide Therapy 4x week for 6 min. treatment time plus standard of care
APT001Nitric Oxide tx 4x week 12 min+SOC
EXPERIMENTALAPT001Nitric Oxide Therapy 4x week for 12 min. treatment time plus standard of care
Interventions
Standard of Care arm which includes wound care, dressings and debridement.
Active Therapy Nitric Oxide delivered topically to the wound twice a week for 6 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
Active Therapy Nitric Oxide delivered topically to the wound twice a week for 12 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
Active Therapy Nitric Oxide delivered topically to the wound four times a week for 6 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
Active Therapy Nitric Oxide delivered topically to the wound four times a week for 12 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
Eligibility Criteria
You may qualify if:
- Diabetes Type 1 or Type 2
- Wound size greater than or equal to 1 cm2 and less than or equal to 16 cm2
- HbA1c less than or equal to 12 %
- Single full thickness DFU on the plantar aspect of toes or foot
- Ankle Brachial Index greater than or equal to 0.7
You may not qualify if:
- Infection of the ulcer
- Active Charcot's disease
- wound involves deeper tissues including bone or tendon
- Negative pressure therapy on affected foot or Hyperbaric Oxygen Therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Origin Inc.lead
Study Sites (15)
Clinical Site
Montgomery, Alabama, 36111, United States
Clinical Site
Phoenix, Arizona, 85015, United States
Clinical Site
Tucson, Arizona, 85634, United States
Clinical Site
Fresno, California, 93721, United States
Clinical Site
Los Angeles, California, 90001, United States
Clinical Site
San Francisco, California, 94115, United States
Clinical Site
Sylmar, California, 91342, United States
Clinical Site
Cooper City, Florida, 33024, United States
Clinical Site
Miami, Florida, 33031', United States
Clinical Site
Miami, Florida, 33032, United States
Clinical Site
Boston, Massachusetts, 02118, United States
Clinical Site
West Columbia, South Carolina, 29033, United States
Clinical Site
Corpus Christi, Texas, 78401, United States
Clinical Site
San Antonio, Texas, 78229, United States
Clinical Site
Webster, Texas, 78245, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David Dantzker, MD
Origin Inc.
- PRINCIPAL INVESTIGATOR
Terry Treadwell, MD
Institute for Advanced Wound Care
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Investigator will be blinded to photgraphs and punch biopsy results
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 14, 2017
Study Start
March 20, 2017
Primary Completion
May 1, 2018
Study Completion
July 1, 2018
Last Updated
June 7, 2017
Record last verified: 2017-06