Clinical trial NCT05570877: ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds
Official title: A Multi-Centre, Randomized, 2-arm, Open-labelled, Controlled PMCF Study to Evaluate the Safety and Performance of ChitoCare Medical Wound Healing Gel in Healing of Chronic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Venous Leg Ulcer
Pressure Ulcer
Lead sponsor: Primex ehf
Sponsor class: INDUSTRY
Collaborators: name: Vizera d.o.o.
name: University of Ljubljana
First posted: 2022-10-07
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We are testing a gel intended for the protection and healing of chronic wounds as a support for standard therapy. The main component of the gel is chitosan, a natural polymer that has the ability to stop bleeding, has a positive effect on wound healing, and has antimicrobial properties.

Detailed description: The purpose of this PMCF study is to evaluate the safety and efficacy of ChitoCare medical Wound Healing Gel for the healing of chronic wounds. The study will enroll patients with diabetic foot ulcer, venous ulcer or pressure ulcer. Patients will be randomly assigned to an active or control group. The active group will apply the gel to the wound, in addition to the standard of care, while the control group will receive only standard care. The study will last from 3 to 18 months for an individual patient (15-month recruitment period and 3 months of follow-up after the last patient is enrolled) or until event occurrence (complete wound healing/exclusion from the study). The study envisages four visits: Visit 1 - Screening and Inclusion visit, Visit 2 (after 4 weeks), Visit 3 (after 12 weeks) and Visit 4 - End of Study Visit: The final visit will take place when the event occurs (complete healing/exclusion from study). On each visit, the patients will have their wound photographed and assessed after debridement. Adverse events will be followed throughout the whole study.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent must be given
2. Patient ≥ 18 years old
3. Presence of chronic wound (Wagner grade I and II diabetic foot ulcer, venous leg ulcer or pressure ulcer) that meets the following criteria:

   * Size of the wound ≥ 0.5 cm2
   * Wound is not infected at the time of randomization
   * Wound is present for at least 4 weeks
4. Able to understand and comply with the requirements of the study

Exclusion Criteria:

1. Patients with serious concomitant disease (cancer, heart failure (NYHA class IV), severe anaemia (Hb\<100 g/L), neoplasia)
2. Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)
3. Patients that will require surgical procedure to treat their ischemic condition on the limb where the wound is present as assessed by the investigator
4. Patients diagnosed with autoimmune connective tissue diseases
5. Previous treatment under this clinical protocol
6. Participation in another clinical trial
7. Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing
8. Allergy to shellfish (for active study group)
9. Medical condition likely to require systemic corticosteroids during the study period
10. Pregnant and lactating women

Primary outcomes:
measure: Time to complete healing
timeFrame: up to 18 months
Secondary outcomes:
measure: Complete healing rate
timeFrame: 4 weeks, 12 weeks
measure: Reduction of wound size
timeFrame: 4 weeks, 12 weeks
measure: Time to 75% and 50% healing
timeFrame: up to 18 months
measure: 75% and 50% healing rate
timeFrame: 4 weeks, 12 weeks
measure: Secondary infections
timeFrame: up to 18 months
measure: Incidence of adverse events (Safety of use)
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital Sveti Duh
city: Zagreb
country: Croatia
facility: Marija Poliklinika
city: Zagreb
country: Croatia
facility: Vuk Vrhovac University Clinic for Diabetes, Endocrinology and Metabolic Diseases, Merkur University Hospital
city: Celje
country: Slovenia
facility: General Hospital Celje
city: Koper
country: Slovenia
facility: Health Centre Koper
city: Maribor
country: Slovenia
facility: University Clinical Center Maribor
city: Poljčane
country: Slovenia
facility: Medicina Mataln
city: Šmarje pri Jelšah
country: Slovenia
facility: Nursing Home Šmarje pri Jelšah
city: Žalec
country: Slovenia
facility: Ordinacija Andrej Kravos
Study officials:
affiliation: Primex ehf
name: Helene Liette Lauzon
role: STUDY_DIRECTOR
References: