ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds (CHITOCHRONIC)

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

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 Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer; Pressure Ulcer
• Intervention / Treatment: Device: ChitoCare medical Wound Healing Gel

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Celje, Slovenia, 3000
    • Recruiting
    • General Hospital Celje
    • Contact: Maja Navodnik Preložnik, MD; Phone Number: +386 3 423 3835; Email: maja.navodnik-preloznik@sb-celje.si
    • Principal Investigator: Maja Navodnik Preložnik, MD
    • Sub-Investigator: Lučka Leskovšek, MD
  • Koper, Slovenia, 6000
    • Recruiting
    • Health Centre Koper
    • Contact: Jana Komel, MD; Phone Number: +386 5 664 72 17; Email: jana.komel@gmail.com
    • Principal Investigator: Jana Komel, MD
  • Maribor, Slovenia, 2000
    • Recruiting
    • University Clinical Center Maribor
    • Contact: Vesna Breznik, MD; Phone Number: +386 2 321 27 05; Email: vesna.breznik@ukc-mb.si
    • Principal Investigator: Vesna Breznik, MD
    • Sub-Investigator: Irena Peteln, MD
    • Sub-Investigator: Martina Lipič, MD
  • Šmarje pri Jelšah, Slovenia, 3240
    • Recruiting
    • Nursing Home Šmarje pri Jelšah
    • Contact: Marko Starbek, MD; Phone Number: +386 7 292 72 10; Email: info@medicina-mataln.si
    • Principal Investigator: Mitja Mataln, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active group; Active group will apply ChitoCare medical Wound Healing Gel to the wound in addition to standard of care.	Device: ChitoCare medical Wound Healing Gel; ChitoCare medical Wound Healing Gel is a CE-marked medical device.
NO_INTERVENTION: Control group; Control group will only administer standard of care to treat their wounds.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Primex ehf
• Collaborators: Vizera d.o.o.; University of Ljubljana, Faculty of Pharmacy

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 11, 2022
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (ACTUAL): October 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Diabetic Foot; Foot Ulcer; Ulcer; Leg Ulcer; Varicose Ulcer; Pressure Ulcer
• Other Study ID Numbers: CHITOC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No