Table of contents
- Trial overview
- Study design and phases
- Who can participate
- What is being measured
- How results are judged
- Why this study matters
Trial overview
This article is about one clinical trial of HUMAN FIBROBLASTS for refractory wounds, which are wounds that are hard to heal.[1] The study is interventional, which means the researchers give a study treatment and then watch what happens.[1]
The trial is authorised and plans to include 52 people.[1] It uses topical use, meaning the treatment is applied on the skin or wound area rather than taken by mouth.[1]
Study design and phases
This is a Phase 1/2 study.[1] Phase 1 studies usually focus on safety first, while Phase 2 studies look more closely at whether the treatment may help.[1]
The study has two parts.[1] In the first part, the team uses an open-label, dose escalation design to test two different doses and find the best dose for the next part.[1] In the second part, the selected dose is tested further to assess efficacy, which means how well it works, and to confirm safety and tolerability.[1]
Open-label means the study is not blinded, so the participants and investigators know what is being used.[1] Dose escalation means the study checks more than one strength in steps before choosing the best one.[1]
Who can participate
The trial is designed for people with chronic refractory wounds.[1] The source data do not give more detailed entry rules, such as age limits or other medical requirements.[1]
Because the study focuses on wounds that do not heal easily, it is meant for patients who have a long-lasting wound problem and need new treatment options.[1]
What is being measured
The main safety measures include Treatment Emergent Adverse Events, also called TEAEs, which are problems that happen after the product is applied.[1] The study also checks changes in physical examination findings, vital signs, 12-lead ECG, blood tests, and urine tests.[1]
Another safety measure is the investigator’s overall tolerability score on a 5-point Likert scale, which is a simple rating scale from very well tolerated to not tolerated at all.[1]
The efficacy measures focus on wound healing and symptom relief.[1] These include change in ulcer size, change in wound area in square centimeters, change in the Wound Bed Score, and change in wound pain using a Visual Analogue Scale or VAS, which is a pain rating scale.[1]
The study also measures the number of responders, meaning people whose ulcer area is reduced by at least 50%, the time to 50% wound reduction, the time to healing if healing happens, and changes in the Wound-QoL-14 questionnaire, which looks at quality of life related to the wound.[1]
How results are judged
The wound size outcome is scored in six categories, from unchanged to fully healed.[1] This helps the researchers see not only whether a wound gets smaller, but also whether it closes completely.[1]
The study also looks at the investigator’s satisfaction with the product’s efficacy using a 5-point Likert scale, which helps show how the treatment performs in real clinical use.[1] Together, these results are meant to give a full picture of safety, healing progress, pain, and patient impact.[1]
Why this study matters
People with refractory wounds often need new options because their wounds are slow to improve.[1] This trial is important because it first tries to find the best dose and then checks whether the chosen dose may help wounds heal better.[1]
The study is focused on practical outcomes that matter to patients, such as wound size, pain, healing time, and quality of life.[1] That makes it a patient-centered trial, with both safety and everyday wound improvement in view.[1]
