MAtrix Therapy for Hard-to-heal ChrOnic Wounds

Launched by ORGAN, TISSUE, REGENERATION, REPAIR AND REPLACEMENT · Dec 9, 2021

Keywords

ClinConnect Summary

The clinical trial titled "MAtrix Therapy for Hard-to-heal ChrOnic Wounds" is studying the effectiveness of a medical device called CACIPLIQ20® in treating chronic wounds, such as leg ulcers and diabetic foot ulcers, that have not improved with other treatments for at least six months. The goal is to see how well this device works in real-life situations, how safe it is, and whether it provides good value for the money spent on treatment.

To participate in the trial, patients must be at least 18 years old and have a chronic wound located below the knee that has not been treated with CACIPLIQ20® before. They should be able to attend follow-up appointments and have valid health insurance. Participants will receive treatment and be monitored over time, helping researchers gather important information about the device's performance. It's important to note that certain people, like those who are pregnant or bedridden, or those with other specific health issues, are not eligible to join the study.

Gender

ALL

Eligibility criteria

• General Inclusion Criteria:
• • Patients justifying a treatment with CACIPLIQ20® according to a care provider.
• • Patients presenting with a chronic wound that has not shown signs of improvement following treatment for at least 6 months prior to inclusion into the study.
• • Adult patients of either gender aged at least 18 and without upper limit for age.
• • Patients having received a full written and oral information about study conduct and objectives and having given a written consent to participate according to local regulations.
• • Patients being seen as outpatients and for whom no hospitalization is expected/planned in the 6 forthcoming weeks.
• • Patients who can and are willing to be followed by a study investigator for the duration of the study.
• • Patients benefiting from a valid health insurance or social security coverage.
• Target Wound Inclusion Criteria:
• • Current wound that has not been previously treated with CACIPLIQ20®.
• • Target wound located below the knee.
• * Target wound is either:
• • 1. a leg ulceration predominantly of venous origin (no ischemia as previously defined) with an area \>10 cm² and/or a duration of at least 5 months,
• • 2. a leg ulceration of any size or duration, with a documented ischemic lower limb problem,
• • 3. a foot ulceration of any size or duration, documented as a diabetic foot ulceration (DFU).
• • If more than one wound is present and eligible, investigators will be required to select one as the target wound for this study. This wound should be the largest one. If wounds are of similar size, the ulceration considered by the investigator as the worst will be selected.
• Exclusion Criteria:
• • Female patients who are pregnant, or lactating.
• • Bedridden patients unable to spend at least one hour per day sitting in a chair.
• • Patients suffering from severe cognitive problems precluding any voluntary participation to the study.
• • Patients with, according to investigator's opinion, a very poor life expectancy.
• • Patients with leg or foot ulcerations which are not of venous, arterial or diabetic origin (e.g. Martell's ulcer and related ulcers, pressure ulcers, traumatic wounds or burns)
• • Patients whose target wound is located on an amputation stump.
• • Patients presenting with a fungating wound at the time of inclusion.
• • Patients in an emergency situation and unable to give consent.
• • Patients intolerant to one of the study device components or to heparinoids.