Treatment for hard-to-heal chronic wounds using CACIPLIQ20

A Prospective Cohort Survey of Foot and Leg Chronic Wounds Followed up to 20 Weeks After Initiation of CACIPLIQ20® add-on to Optimal Local Care

This study is testing a new medical device called CACIPLIQ20 to see if it can help heal stubborn chronic wounds that haven’t improved with regular treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Organ, Tissue, Regeneration, Repair and Replacement (industry)
• Locations: 1 site (Montpellier)
• Trial ID: NCT05170984 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of CACIPLIQ20®, a bioengineered medical device, in treating chronic wounds that have not improved after six months of standard care. It involves a prospective collection of patient data in real-life conditions to assess the device's efficacy, safety, and cost-effectiveness. The study focuses on various types of chronic ulcers, including diabetic foot ulcers and venous leg ulcers, and aims to provide a standardized approach to managing these difficult cases.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with chronic wounds below the knee that have not shown improvement after at least six months of treatment.

Not a fit: Patients with wounds that have previously been treated with CACIPLIQ20® or those requiring hospitalization in the near future may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing outcomes for patients with chronic wounds that are resistant to conventional therapies.

How similar studies have performed: Previous studies have shown promising results with similar bioengineered treatments for chronic wounds, indicating potential for success in this approach.

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.

Where this trial is running

Montpellier

• Réseau Cicat-Occitanie — Montpellier, France (RECRUITING)

Study contacts

• Principal investigator: Luc TEOT, MD, PhD — Réseau Cicat-Occitanie
• Study coordinator: Frédéric SEDEL, MD, PhD

Conditions: Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer, Arterial Ulcer, Venous Ulcer of Leg, CACIPLIQ20, Chronic Wound, Chronic Ulcer, Hard-to-heal Wound