MAtrix Therapy for Hard-to-heal ChrOnic Wounds

NCT05170984 | Completed DMC

• 1 other identifier: 2021-A01910-41
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief Summary

CACIPLIQ20® is currently a class III CE marked medical device available in various European and non-European countries, and currently primarily used in managing hard-to-heal wounds. This study is a prospective and standardized recording of patients' data followed in real-life conditions to appreciate the benefits of a therapeutic strategy including CACIPLIQ20® use. It also aims at collecting data to follow-up the device's efficacy and safety and estimate its cost-effectiveness.

Conditions

Chronic Ulcer of Leg or Foot; Arterial Ulcer; Venous Ulcer of Leg; Diabetic Foot Ulcer

Keywords

CACIPLIQ20; Chronic Wound; Chronic Ulcer; Hard-to-heal Wound

Outcome Measures

Primary Outcomes (1)

• Rate of wound closure

  Wound closure defined as a 100% re-epithelialization, including: * A confirmed complete closure (CCC), defined as a wound closure notified by investigator and confirmed by an independent reviewer when analysing wound photos. * A possible complete closure (PCC), defined as a wound closure notified by investigator without confirmation by the independent reviewer (either no photo or photo of too poor quality or no unambiguous confirmation). The primary endpoint is the sum of CCC and PCC.

  Within 20 weeks after treatment initiation

Secondary Outcomes (5)

• Rate of adverse events (AEs) related to CACIPLIQ20® use

  From baseline to wound closure or 20 weeks after treatment initiation

• Rate of device deficiencies (DDs)

  From baseline to wound closure or 20 weeks after treatment initiation

• Rate of wound closure according to the type of closure (CCC, PCC) and according to the nature of the treated wounds (Venous Leg Ulcers, Arterial Ulcers and Diabetic Foot Ulcers).

  Within 20 weeks after treatment initiation

• Time to wound closure

  Within 20 weeks after treatment initiation

• Changes in the Pain Visual Analogic Scale

  From baseline to wound closure or 20 weeks after treatment initiation

Study Arms (1)

CACIPLIQ20®

EXPERIMENTAL

Treatment of the target wound with CACIPLIQ20® in addition to optimal local care

Device: CACIPLIQ20®

Interventions

CACIPLIQ20® DEVICE

Application of CACIPLIQ20® by spray, directly on the wound surface, after wound cleaning and debridement, twice a week, until wound closure (or up to 20 weeks maximum).

CACIPLIQ20®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients justifying a treatment with CACIPLIQ20® according to a care provider.
• 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.
• Current wound that has not been previously treated with CACIPLIQ20®.
• Target wound located below the knee.
• Target wound is either:
• 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,
• a leg ulceration of any size or duration, with a documented ischemic lower limb problem,
• 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.

You may not qualify if:

• 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 in an emergency situation and unable to give consent.
• Patients intolerant to one of the study device components or to heparinoids.

Sponsors & Collaborators

• Organ, Tissue, Regeneration, Repair and Replacement: lead

Study Sites (1)

Réseau Cicat-Occitanie

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Study Officials

• Luc TEOT, MD, PhD

  Réseau Cicat-Occitanie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 28, 2021
• Study Start: February 10, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 30, 2024
• Last Updated: April 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)