Iontophoresis of Treprostinil to Enhance Wound Healing in Diabetic Foot Skin Ulcers

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Assess the effect of iontophoresis of treprostinil on wound closure over 12 weeks, in patients with DFU.

In the present study the investigators aim at establishing the proof-of-concept of iontophoresis of treprostinil as a potential treatment of diabetic foot ulcers in humans. The main hypothesis is that in patients with DFUs, the pharmacodynamic effect of a PGI2 analogue potentiates the effect of low-intensity current on microvascular function, tissue oxygenation and healing.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Treatments: Treprostinil

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