NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers (NCT06402565) | Clinical Trial Compass
Active — Not RecruitingPhase 1
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers
United States40 participantsStarted 2024-06-06
Plain-language summary
The goal of this multi-center, randomized, controlled, evaluator-blinded study is to assess and measure the safety and efficacy of NOX1416 as an adjunct to standard of care (SOC) in the treatment of chronic, non-healing, diabetic foot ulcers (DFUs). Subjects will be randomized to receive treatment with NOX1416 as an adjunct to Standard of Care (SOC) or SOC alone.
The primary objective of the study is to demonstrate the safety and tolerability of NOX1416 as adjunct to SOC. The secondary objective of the study is to evaluate the clinical benefit of daily NOX1416, as an adjunct to SOC, in the treatment of chronic, non-healing diabetic foot ulcers. The study will use a centralized blinded assessor. The blinded assessor will be responsible for assessing the efficacy endpoints such as wound measurements and complete wound closure. The blinded assessor will not be involved in the clinical care of the subject.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female subjects aged 18 to 80 years (inclusive) with Type 1 or Type 2 diabetes requiring treatment with oral medications and/or insulin replacement therapy
. Subject has a glycosylated hemoglobin, HbA1c ≤ 12%. Note: Prior documented HbA1c within the last 3 months of the Screening Visit is acceptable.
. Presence of at least one diabetic foot ulcer that meets all of the following criteria:
. A full-thickness ulcer of University of Texas Wound Classification (UTWCS) Grade IA or IIA
. At least 50% of the ulcer is located below the malleoli
. Ulcer size (area) is ≥ 1 cm2 and ≤ 10 cm2 (post-debridement at time of randomization)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of subjects with a Methemoglobin >5% at any assessment point
Timeframe: 14 weeks
2
Incidence and severity of treatment-emergent adverse events (TEAEs)
. Unresponsive to standard ulcer care for ≥ 4 weeks (at time of screening)
. There is a minimum 1 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, post-debridement)
Exclusion criteria
. Ulcers with exposed bone or associated with osteomyelitis. Note: Osteomyelitis should be ruled out by clinical examination (probing of the wound) or X-ray findings, if necessary, by the Investigator.
. Subject has ulcers secondary to a disease other than diabetes, e.g., fungal ulcerations, malignant ulcerations, and ulcerations due to venous or arterial insufficiency, or due to hematological disorders, in the opinion of the Principal Investigator.
. Ulcer, which in the opinion of the Investigator, is suspicious for cancer.
. Subjects with a gangrenous or ischemic toe that may need to be amputated in the opinion of the Investigator.
. Body mass index (BMI) \> 40kg/m2
. Methemoglobin \> 5% at SV1
. Laboratory values at Screening of:
. Presence of any clinically significant medical condition(s) that, in the opinion of the Investigator, could interfere with wound healing, including but not limited to the following: