Iontophoresis of Treprostinil to Enhance Wound Healing in Diabetic Foot Skin Ulcers (InTREPiD)
Diabetic Foot Ulcer
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Iontophoresis, Treprostinil, Diabetic, Foot Ulcer, Wound Healing
Eligibility Criteria
Inclusion Criteria:
Patients with type 2 diabetes according to the criteria of the American Diabetes Association (ADA), with one or more foot ulcer of microvascular or mixed etiology:
- The ulcer size must be ≥1 cm² and <20 cm²
- Grade 1A, 1C, 2A or 2C (University of Texas Classification of Diabetic Foot)
- Patient affiliated to social security insurance or beneficiary of social security insurance.
Exclusion Criteria:
- History of hypersensitivity reaction to treprostinil
- Pulmonary veno-occlusive disease (PVOD)
- Systemic treatment with any PGI2 analogue in the past two months.
- Critical ischemia of the lower limb, defined as leg pain at rest associated with ankle pressure <50 mmHg.
- Infected wound, treated with antibiotics in the past 15 days.
- Active or uncontrolled cardiovascular disease as follows:
- Myocardial infarction, or angina within 6 months of study participation
- Arrhythmia (uncontrolled, highly symptomatic, requires treatment or life-threatening).
- Congestive heart failure.
- Stroke or transient ischemic attack within 3 months of study participation
- Uncontrolled hypertension: systolic blood pressure> 180 mmHg or diastolic blood pressure> 105 mmHg (2 abnormal readings during visit)
- Valvular heart disease
- Severe liver disease (Child-Pugh C) at the time of enrollment
- Active gastroduodenal ulcer
- Intracerebral hemorrhage
- Trauma or any clinical event susceptible to be responsible for hemorrhage within 6 months of study participation
- Renal disease (creatinine > 2 mg/dL and/or estimated glomerular filtration rate<30 mL/min, history of dialysis)
- 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.
- Pregnancy or Lactation
- Females of childbearing potential not using an effective form of birth control as determined by the investigators.
- Participant involved in another interventional clinical study
- Person deprived of liberty by judicial order
- Person under guardianship or curatorship
Sites / Locations
- CHU Grenoble AlpesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
No Intervention
Treprostinil iontophoresis
Remodulin® Placebo iontophoresis
Standard care
Gel of treprostinil 1 mg/mL (target concentration) Part 1: 1 administration/day, on separate days, with 72h between two doses. Ascending doses are 0.025 mg/mL, 0.05mg/mL, 0.1 mg/mL, 0.25 mg/mL, 0.5 mg/mL, 0.7 mg/mL, and 1 mg/mL. The intensity will be set at 120 µA during 60 minutes, i.e. a total current of 17.3 mC/cm². Part 2: 1 administration/day at the maximum tolerated dose (MTD) for 10 days; dressing will be changed by a trained nurse every 2 days. The intensity will be set at 120 µA during 60 minutes, i.e. a total current of 17.3 mC/cm².
Placebo will be made from the placebo of Remodulin® incorporated into hydrogel (Suprasorb® G). The route and frequency of administration will be the same as for the investigational drug (topical administration by iontophoresis).
subjects randomized to the standard of care group (no iontophoresis) will only undergo standard blood test at visit 0 or 1, unless tests <1 month before inclusion are available This group is not double blind Standard care consists on debridement and dressings