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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer

Intervention / Treatment
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* Device: ChitoCare medical Wound Healing Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be given Patient ≥ 18 years old 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 Able to understand and comply with the requirements of the study Exclusion Criteria: Patients with serious concomitant disease (cancer, heart failure (NYHA class IV), severe anaemia (Hb<100 g/L), neoplasia) Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness) Patients that will require surgical procedure to treat their ischemic condition on the limb where the wound is present as assessed by the investigator Patients diagnosed with autoimmune connective tissue diseases Previous treatment under this clinical protocol Participation in another clinical trial 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 Allergy to shellfish (for active study group) Medical condition likely to require systemic corticosteroids during the study period Pregnant and lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active group<br>Active group will apply ChitoCare medical Wound Healing Gel to the wound in addition to standard of care. | Device: ChitoCare medical Wound Healing Gel<br>* ChitoCare medical Wound Healing Gel is a CE-marked medical device.<br>|
| No Intervention: Control group<br>Control group will only administer standard of care to treat their wounds. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete healing | Hazard ratio for time to complete healing (active group vs. control group). | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete healing rate | Proportion of completely healed ulcers (active group vs control group). | 4 weeks, 12 weeks | 
| Reduction of wound size | Relative reduction of wound surface area compared to baseline (active group vs control group). | 4 weeks, 12 weeks | 
| Time to 75% and 50% healing | Hazard ratio for time to 75% and 50% healing | up to 18 months | 
| 75% and 50% healing rate | Proportion of 75% and 50% area healed ulcers (active group vs. control group) | 4 weeks, 12 weeks | 
| Secondary infections | Occurrence of secondary infections | up to 18 months | 
| Safety of use | Incidence of adverse events | up to 18 months |