NCT05145439 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Kalani M, Brismar K, Fagrell B, Ostergren J, Jorneskog G
Transcutaneous oxygen tension and toe blood pressure as predictors for outcome of diabetic foot ulcers. Diabetes Care. 1999 Jan;22(1):147-51. doi: 10.2337/diacare.22.1.147.
Yang C, Weng H, Chen L, Yang H, Luo G, Mai L, Jin G, Yan L
Transcutaneous oxygen pressure measurement in diabetic foot ulcers: mean values and cut-point for wound healing. J Wound Ostomy Continence Nurs. 2013 Nov-Dec;40(6):585-9. doi: 10.1097/WON.0b013e3

A Non-significant Risk Clinical Study to Assess Changes in Perfusion, Oxygenation, and Hemoglobin Content After Application of the VibratoSleeve, a Therapeutic Ultrasound (TUS) Phased Array, for Patients With Ischemic and Neuroischemic Diabetic Foot Ulcers (DFU)

Details for clinical trial NCT05145439

Clinical trial NCT05145439 - References