New gel helps stubborn wounds heal faster in real-world study
NCT ID NCT05170984
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study followed 191 adults with chronic leg or foot ulcers that hadn't improved for at least 6 months. They received a gel called CACIPLIQ20 added to standard wound care. Researchers tracked how many wounds fully closed within 20 weeks and checked for side effects. The goal was to see if the gel helps heal these tough wounds in everyday medical practice.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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191 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Dec 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Réseau Cicat-Occitanie
Montpellier, 34295, France
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Other studies related to the condition(s) this trial covers.
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