Skin Flap clinical trials

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.

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NCT ID: NCT04828304 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

PLASOMA Ultimate Safety & Efficacy Study

PULSE

Start date: May 26, 2021
Phase: N/A
Study type: Interventional

The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: 1. Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. 2. Efficacy: To confirm the performance of PLASOMA, i.e. the beneficial effect on bacterial load. B. Determine the effect of PLASOMA on wound surface area. A secondary purpose is to examine the beneficial effects of PLASOMA on wound healing and to perform a health technology assessment (HTA). This clinical study will be an open label two-armed randomized controlled trial (RCT), performed at at least three sites (multi-center) in the Netherlands. The two arms are: 1. Control group: Standard wound care for 12 weeks or until healing, whichever occurs first; 2. Treatment group: Standard wound care + PLASOMA treatment for 12 weeks or until healing, whichever occurs first. The frequency of PLASOMA treatment will be determined by the treating (para)medical professional based on the number of visits they would schedule for the standard wound care at the study site. For all study subjects, the treatment frequency will be at least once per week (in order to have enough treatments for safety evaluation) and should not exceed once per day. Follow up (FU) will be performed at three timepoints for both arms: - FU1: 2 weeks after end treatment period - FU2: 12 weeks after end treatment period - FU3: 12 months after start treatment.