NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers (NTCDU) (NCT06020664) | Clinical Trial Compass
SuspendedPhase 1
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers (NTCDU)
Stopped: The NO-002 study had to be paused because of enrollment disruptions due to the current situation in Israel, and concerns over the placebo batch stability results.
Israel30 participantsStarted 2023-08-16
Plain-language summary
The goal of this multi-center,randomized, placebo controlled, evaluator-blinded study is to assess the efficacy and safety 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 SOC.
The primary objective of the study is to evaluate the clinical benefit of daily NOX1416, as an adjunct to standard of care (SOC), in the treatment of chronic, non-healing DFUs. The secondary objective is to demonstrate efficacy, safety and tolerability of NOX1416 as adjunct to SOC. Each site will assign a physician (or designee) to serve as the "blinded-evaluator" to be responsible for assessing the study endpoints such as wound measurements and complete wound closure. The blinded-evaluator will not be involved in the clinical care of the subject.
Who can participate
Age range18 Years ā 80 Years
SexALL
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Inclusion criteria
ā. Male or female subjects aged 18 to 80 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control.
ā. Subject has a glycosylated hemoglobin, HbA1c ā¤ 12%. Note: Prior documented HbA1c within the last 3 months of the Screening Visit is acceptable.
ā. Presence of at least one diabetic foot ulcer that meets all of the following criteria:
ā. A full-thickness ulcer of University of Texas Wound Classification (UTWCS) Grade I or II
ā. Ulcer is located on or below the malleoli
ā. Ulcer size (area) is ā„ 1 cm2 and ā¤ 10 cm2 (post-debridement at time of randomization)
ā. Unresponsive to standard ulcer care and present for ā„1 month and ā¤1 year (at time of screening)
ā. There is a minimum 1 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot, post-debridement)
Exclusion criteria
ā
What they're measuring
1
Proportion of subjects with complete wound closure during the 12 weeks of the Treatment Phase
. 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.
ā. 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.
ā. Ulcer, which in the opinion of the Investigator is suspicious for cancer. Note: Ulcers present for \> 6 months would require biopsy to be performed to rule out malignancy.
ā. Subjects with a gangrenous or ischemic toe that may need to be amputated in the opinion of the Investigator.
ā. Body mass index (BMI) \> 40kg/m2
ā. Laboratory values at Screening of:
ā. Hemoglobin \< 8.5 g/dL
ā. White Blood Cells (WBC) \< 3.0 X 109 cells/L and \> 11 x 109 cells/L