NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers (NTCDU)

NCT06020664 | Suspended Phase 1

• 1 other identifier: NO-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with complete wound closure during the 12 weeks of the Treatment Phase

  Complete wound closure is defined as 100% re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart. Complete wound closure will be evaluated by the blinded evaluator.

  12 weeks

Secondary Outcomes (53)

• Wound Area Change (%) during the 12 weeks of the Treatment Phase

  12 weeks

• Time to complete wound closure during the 12 weeks of the Treatment Phase

  12 weeks

• Frequency of required debridement during the 12 weeks of the Treatment Phase

  12 weeks

• Incidence and severity of treatment-emergent adverse events (TEAEs), including serious adverse events and adverse events resulting in permanent discontinuation of protocol-defined therapy

  Up to 24 weeks

• Change in hemoglobin from baseline to subsequent scheduled visits

  Up to 24 weeks

Study Arms (2)

NOX1416+SOC

EXPERIMENTAL

NOX1416 is a foam based gaseous nitric oxide (NO) product that will be topically applied directly onto the wound bed and left on the wound bed for a 5-minute period. 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. Standard of care will include evaluation to document, off-loading adequate arterial flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of moist wound environment, and management of infection.

Drug: NOX-1416+SOC

Placebo+SOC

PLACEBO COMPARATOR

Placebo is topically applied directly onto the wound bed and left on the wound bed for a 5-minute period. 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, off-loading adequate arterial flow, wound cleaning, removal of necrotic, infected and/or nonviable tissue by debridement, maintenance of moist wound environment, and management of infection.

Other: Placebo+SOC

Interventions

NOX-1416+SOC DRUG

NOX1416+SOC as provided in Arm/group description

Also known as: Advanox

NOX1416+SOC

Placebo+SOC OTHER

Placebo+SOC as provided in Arm/group description

Placebo+SOC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:
• Male or female subjects aged 18 to 80 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control.
• 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 I or II
• Ulcer is located on or below the malleoli
• Ulcer size (area) is ≥ 1 cm2 and ≤ 10 cm2 (post-debridement at time of randomization)
• Unresponsive to standard ulcer care and present for ≥1 month and ≤1 year (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)
• No exposed bone and no tunneling, undermining, or sinus tracts
• Ulcer must be non-healing as defined as \<35% reduction in size in response to standard of care during the two-week run-in Screening Period (between the first Screening Visit and Baseline) Note: Criterion 3(g) will be evaluated at the time of randomization. If the subject has more than one qualifying diabetic foot ulcer, the ulcer designated as the Target Ulcer will be at the discretion of the Investigator.
• Subject has adequate vascular perfusion of the affected limb, confirmed by Ankle-Brachial Index (ABI) ≥ 0.6 and ≤ 1.2. ABI results within the last 3 months of Screening are acceptable. The assessment may also be performed between SV1 and SV2.
• Clinically normal resting ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
• Subject, if female of child-bearing potential, has a negative serum pregnancy test at screening, must not be breastfeeding, and willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) throughout the study.
• Subject is able and willing to comply with study procedures and applicable dressing changes.

You may not qualify if:

• Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:
• 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. Note: Ulcers present for \> 6 months would require biopsy to be performed to rule out malignancy.
• 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
• Laboratory values at Screening of:
• Hemoglobin \< 8.5 g/dL
• White Blood Cells (WBC) \< 3.0 X 109 cells/L and \> 11 x 109 cells/L
• Liver function studies \[Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)\] \> 3x the upper limit of normal
• Albumin \< 2.5 g/dL
• Renal function studies \[Serum Creatinine and Urea\] \> 3x the upper limit of normal
• 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:
• Vasculitis or connective tissue disease
• Buerger's disease, Raynaud's or other peripheral vascular disease.

Sponsors & Collaborators

• NOxy Health Products, LLC: lead

Study Sites (6)

Soroka Medical Center (Site 106)

Beersheba, Israel

Location

Carmel Medical Center (Site 104)

Haifa, Israel

Location

Shaare Zedek Hospital (site 101)

Jerusalem, 9103102, Israel

Location

Hadassah Medical Organization (Site 105)

Jerusalem, Israel

Location

Meir Medical Center (Site 103)

Jerusalem, Israel

Location

Laniado Hospital (Site 102)

Netanya, Israel

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Gabriel Halperin, MD

  Mission Community Hospital, CA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluator-Blinded Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of 30 subjects will be randomized 1:1 to receive either NOX1416 + SOC or Placebo + SOC (15 per group).

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 31, 2023
• Study Start: August 16, 2023
• Primary Completion: September 1, 2024
• Study Completion: November 24, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (6)