ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds

Primex ehf92 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Foot Ulcer Venous Leg Ulcer Pressure Ulcer

Interventions

ChitoCare medical Wound Healing GelDEVICE

ChitoCare medical Wound Healing Gel is a CE-marked medical device.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Vuk Vrhovac University Clinic for Diabetes, Endocrinology and Metabolic Diseases, Merkur University Hospital

Zagreb, City of Zagreb, Croatia

Clinical Hospital Sveti Duh

Zagreb, Croatia

Marija Poliklinika

Zagreb, Croatia

Medicina Mataln

Outcomes

Primary Outcomes

Time to complete healing

Hazard ratio for time to complete healing (active group vs. control group).

Time frame: up to 18 months

Secondary Outcomes

Complete healing rate

Proportion of completely healed ulcers (active group vs control group).

Time frame: 4 weeks, 12 weeks

Reduction of wound size

Relative reduction of wound surface area compared to baseline (active group vs control group).

Time frame: 4 weeks, 12 weeks

Time to 75% and 50% healing

Hazard ratio for time to 75% and 50% healing

Time frame: up to 18 months

75% and 50% healing rate

Proportion of 75% and 50% area healed ulcers (active group vs. control group)

Time frame: 4 weeks, 12 weeks

Secondary infections

Occurrence of secondary infections

Time frame: up to 18 months

Incidence of adverse events (Safety of use)

Incidence of adverse events

Time frame: up to 18 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.