drugset / Trial / NCT03654989
Iontophoresis of Treprostinil to Enhance Wound Healing in Diabetic Foot Skin Ulcers
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2020-01-28
- Primary completion
- 2021-12-07
- Completion
- 2021-12-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Treprostinil | Other / unclassified | 0.025 mg/ml | Topical |
| Subject | Treprostinil | Other / unclassified | 0.05 mg/ml | Topical |
| Subject | Treprostinil | Other / unclassified | 0.1 mg/ml | Topical |
| Subject | Treprostinil | Other / unclassified | 0.25 mg/ml | Topical |
| Subject | Treprostinil | Other / unclassified | 0.5 mg/ml | Topical |
| Subject | Treprostinil | Other / unclassified | 0.7 mg/ml | Topical |
| Subject | Treprostinil | Other / unclassified | 1 mg/ml | Topical |