Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402565
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-04-23
Brief Title:
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers
Sponsor:
NOxy Health Products LLC
Organization:
NOxy Health Products LLC
Study Overview
Official Title:
A Randomized Controlled Evaluator-Blinded Study to Assess the Safety and Efficacy of NOX1416 in the Treatment of Chronic Non-Healing Diabetic Foot Ulcers
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NTCDU
Brief Summary:
The goal of this multi-center randomized placebo-controlled evaluator-blinded study is to assess the safety and efficacy of NOX1416 in the treatment of chronic non-healing diabetic foot ulcers DFUs Subjects will be randomized to receive treatment with NOX1416 or placebo as an adjunct to Standard of Care SOC
The primary objective of the study is to demonstrate the safety and tolerability of NOX1416 as adjunct to SOC The secondary objective is to evaluate the clinical benefit of daily NOX1416 as an adjunct to standard of care SOC Each site will assign a physician or designee to serve as the blinded evaluator who is responsible for assessing the study endpoints The blinded evaluator will not be involved in the clinical care of subjects
The primary objective of the study is to demonstrate the safety and tolerability of NOX1416 as adjunct to SOC The secondary objective is to evaluate the clinical benefit of daily NOX1416 as an adjunct to standard of care SOC Each site will assign a physician or designee to serve as the blinded evaluator who is responsible for assessing the study endpoints The blinded evaluator will not be involved in the clinical care of subjects
Detailed Description:
A total of 40 subjects 25 in the treatment group and 15 in the control group will be randomized to receive either NOX1416 plus SOC or Placebo plus SOC NOX1416 is a foam based gaseous nitric oxide NO product where NO is delivered topically through a microbubble foam One pump each of Solution A 03g containing citric acid and Solution B 03g containing sodium nitrite will be dispensed mixed for five seconds and applied immediately per each square centimeter of wound area using any sterile applicator NOX1416 is left on the wound bed for a 5-minute period then removed with a sterile gauze and the standard of care dressing applied
Subjects randomized to the NOX1416 treatment group will receive once a day application for a total of 12 weeks with a double treatment 10 minutes apart on the first day Similar to the NOX1416 treatment schedule placebo will be topically applied directly onto the wound bed and left on the wound bed for a 5-minute period removed and the SOC dressing applied Subjects randomized to the control group will receive once a day application for a total of 12 weeks with a double treatment 10 minutes apart on the first day
Standard of care will include evaluation to document offloading adequate arterial flow wound cleansing removal of necrotic infected andor nonviable tissue by debridement maintenance of a moist wound environment and management of infection
Subjects randomized to the NOX1416 treatment group will receive once a day application for a total of 12 weeks with a double treatment 10 minutes apart on the first day Similar to the NOX1416 treatment schedule placebo will be topically applied directly onto the wound bed and left on the wound bed for a 5-minute period removed and the SOC dressing applied Subjects randomized to the control group will receive once a day application for a total of 12 weeks with a double treatment 10 minutes apart on the first day
Standard of care will include evaluation to document offloading adequate arterial flow wound cleansing removal of necrotic infected andor nonviable tissue by debridement maintenance of a moist wound environment and management of infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None