Phase 3 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with diabetes and have a diabetic foot ulcer.
• People aged 18 years or older, of any gender.
• People whose blood sugar control falls within a certain range — specifically, an HbA1c (a measure of long-term blood sugar) below 12% and a random blood sugar reading below 350 mg/dl.
• People who are medically stable and show no signs of serious infection (sepsis), based on a standard clinical score called qSOFA being below 2.
• People whose blood flow to the lower legs falls within an acceptable range, as measured by a test called the Ankle Brachial Index (ABI), with a result between 0.7 and 1.2.
• People whose foot ulcer has been present for more than 30 days but less than 2 years.
• People whose wound measures between 0.5 and 20 square centimetres in surface area.
• People whose wound goes as deep as muscle tissue but not into bone (classified as University of Texas Grade and Stage 1A, 1B, 2A, or 2B — confirm with trial site if unsure what this means).
• People who are willing and able to give written informed consent after fully understanding what the study involves (an impartial witness may assist if the person cannot sign due to illiteracy).
• People who understand the research process and are willing to follow all study requirements and attend all scheduled follow-up visits until the end of the study.

Who may not be able to join:

• People whose vital signs or physical examination results are found to be significantly abnormal by the study investigators at the screening stage.
• People with a history of severe allergic reactions to any medications, vaccines, or foods, or who are known to be allergic to any ingredient in the experimental treatment.
• People who have been diagnosed with a serious or chronic condition that may interfere with the study, including (but not limited to) serious respiratory, heart, or brain-related disease, kidney disease, poorly controlled diabetes, autoimmune disease, certain blood disorders, cancer, or hereditary allergic conditions.
• People who are currently participating in, or planning to join, another clinical trial involving drugs or vaccines within the 3 months before joining this study.
• People whom the investigators consider unsuitable for the study for any other reason.
• People who are medically unstable or show signs of serious infection (sepsis), with a qSOFA score of 2 or higher.
• People who have more than 2 ulcers on the foot and leg.
• People whose wound extends into bone, or is classified as University of Texas Grade/Stage C, D, or Grade 3 (confirm with trial site if unsure).
• People whose blood flow test (ABI) result shows moderate to severe blockage — that is, a reading below 0.7 or above 1.3.
• People with an HbA1c above 12% or a random blood sugar reading above 350 mg/dl.
• People with evidence of heart disease or heart failure detected on heart tests (such as an ECG or echocardiogram).
• People whose kidneys are not functioning well enough, as measured by a test called eGFR falling below 60 ml/min/1.73 m².
• People who are pregnant, breastfeeding, or of childbearing potential and not using contraception.
• People who have a known sensitivity to the investigational product or to chlorophyll-based compounds.
• People who have been diagnosed with a condition called porphyria.
• People who require certain eye procedures (slit-lamp examination, YAG laser, or anti-VEGF injections) within the next 30 days.
• People who do not provide written informed consent.
• People who are unable or unwilling to follow the study's requirements.
• People whose ulcer is caused by something other than diabetes, such as poor vein or artery function, or a burn.
• People whose ulcer is less than 3 centimetres away from another ulcer on the same limb.
• People whose ulcer involves bone infection (osteomyelitis), exposed bone, or gangrene.
• People whose wound has decreased in size by more than 40% between the initial screening visit and the first study visit.
• People with a medically confirmed history of HIV.
• People with severe protein malnutrition, defined as a serum albumin level below 2.5 g/dL (a blood protein measure).
• People with certain liver enzyme levels (AST or ALT) that are more than twice the upper limit of normal on blood tests.
• People with a documented or self-reported history of alcohol or substance misuse within the past 12 months.
• People who have received certain treatments in the 60 days before screening, including immunosuppressive drugs, radiation, chemotherapy, wound growth factors, skin grafts, engineered tissue products, or other investigational drugs or devices applied to the ulcer site.
• People whose inflammation markers on blood tests (ESR above 70 mm/h and CRP above 100 mg/L) are elevated at the time of screening.

Important: Always verify eligibility with the trial site directly before applying.