Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT05099367
Eligibility Criteria:
Inclusion criteria:
Groups 1,2,3,4:
* Informed consent signed
* Affiliated to social security insurance or beneficiary of social security insurance
* Aged of 18 or older
Group 1: healthy volunteers:
-Free from all acute and chronic pathology
Group 2: diabetic patients without DFU:
-Patients with type 2 diabetes according to the criteria of the American Diabetes Association (ADA), without DFU or history of DFU
Group 3: diabetic patients with DFU or recent history of DFU (occurred within the last two years):
-Patients with type 2 diabetes according to the criteria of the American Diabetes Association (ADA) with: One or more active grade 1A, 1C, 2A or 2C (University of Texas Classification of Diabetic Foot) foot ulcer of microvascular or mixed etiology; Or a recent history (\<2 years) of foot ulcer of microvascular or mixed etiology.
Group 4 (to collect samples of foot skin biopsies to address secondary objectives ):
-Patients with type 2 diabetes according to the criteria of the American Diabetes Association (ADA),with neuropathy and DFU undergoing lower-limb surgery for skin ulcer (e.g. toe amputation).
Exclusion criteria
Groups 1, 2 and 3:
* Unstable diabetes that has resulted in hyperosmolar coma or ketoacidosis, and/or documented increase or decrease in HbA1c of more than 2.0% within the previous 3 months.
* Presence of diabetic peripheral neuropathy above the ankle, defined as a scoring \>3 of at least two of the four stimuli of the Neuropathy Disability Score (i.e. pinprick sensation, light touch, vibration, and temperature perception) (37).
* Infected wound, treated with antibiotics in the past 15 days.
* Critical ischemia of the lower limb, defined as leg pain at rest associated with ankle pressure \<70 mmHg.
* History of hypersensitivity reaction to treprostinil, fluconazole, other azole compounds, L-NMMA, ketorolac, meloxicam, or any NSAIDs or acetylsalicylic acid, lidocaine (or any local anesthetic with an amide bond), or their excipients
* History of asthma, rhinitis, nasal polyps, angioedema, hives rash, or any other allergic reaction due to acetylsalicylic acid or any NSAID taking
* Pulmonary veno-occlusive disease (PVOD)
* Porphyria
* Hyperkalemia
* Active or uncontrolled cardiovascular disease as follows: Myocardial infarction, or angina within the previous 6 months; Severe ischemic heart disease; Arrhythmia (uncontrolled, symptomatic, requiring treatment or life-threatening); Congestive heart failure, or decompensated heart failure not medically controlled; Stroke or transient ischemic attack within the previous 3 months; Uncontrolled hypertension: systolic blood pressure (SBP)\> 180 mmHg or diastolic blood pressure (DBP)\> 105 mmHg (2 abnormal readings during visit) Valvular heart disease
* Severe liver disease (Child-Pugh C) at the time of enrollment
* Renal disease (creatinine \>2 mg/dL and/or estimated glomerular filtration rate (GFR) \<30 mL/min, history of dialysis)
* Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or history of peptic ulcer disease or gastrointestinal bleeding or perforation with NSAIDs
* Intracerebral or gastrointestinal hemorrhage, hemostasis disorder or every clinical status that may lead to bleeding
* Chronic venous disease defined as stage 4a and 4b of the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification
* Cutaneous condition deemed incompatible with skin biopsy and dermal microdialysis by the investigator
* History of necrotic angiodermatitis
* Trauma or any clinical event susceptible to be responsible for hemorrhage within the previous 6 months
* Concomitant treatment with pentoxifylline, anticoagulants, probenecid, medicinal products known to prolong the QT interval or anti-inflammatory or analgesic dose of acetylsalicylic acid
* If concomitant treatment with NSAIDs, participants have to be stopped 1 week before the inclusion
* Pregnancy or Lactation
* Females with childbearing potential, defined as a premenopausal female capable of becoming pregnant, and not using an highly effective form of birth control. Effective birth control methods include: oral, implant or patch hormone contraception; intrauterine device; abstinence and outercourse; tubal ligation; vasectomy.
Groups 1,2,3 and 4:
* Participant involved in another interventional clinical study
* Person deprived of liberty by judicial order
* Person under guardianship or curatorship
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05099367
Study Brief:
Protocol Section:
NCT05099367