A Feasibility Study of Advance Plasma Therapy001 Plasma/Nitric Oxide Therapy for the Treatment of Diabetic Foot Ulcers
Diabetic Foot Ulcer
About this trial
This is an interventional device feasibility trial for Diabetic Foot Ulcer focused on measuring DFU
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Clinical SiteRecruiting
- Clinical SiteRecruiting
- Clinical SiteRecruiting
- Clinical SiteRecruiting
- Clinical SiteRecruiting
- Clinical SiteRecruiting
- Clinical SiteRecruiting
- Clinical SiteRecruiting
- Clinical SiteRecruiting
- Clinical SiteRecruiting
- Clinical SiteRecruiting
- Clinical SiteRecruiting
- Clinical SiteRecruiting
- Clinical SiteRecruiting
- Clinical SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Experimental
Experimental
Experimental
Experimental
Standard of Care
APT001NitricOxide tx 2x week 6 min+ SOC
APT001Nitric Oxide tx 2x week 12 min+SOC
APT001Nitric Oxide tx 4x week 6 min+SOC
APT001Nitric Oxide tx 4x week 12 min+SOC
Standard of care for diabetic foot ulcer wound care
APT001 Nitric OxideTherapy 2x week for 6 min. treatment time plus standard of care
APT001Nitric Oxide Therapy 2x week for 12 min. treatment time plus standard of care
APT001 Nitric Oxide Therapy 4x week for 6 min. treatment time plus standard of care
APT001Nitric Oxide Therapy 4x week for 12 min. treatment time plus standard of care