NCT05570877

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

2.8 years

First QC Date

October 4, 2022

Last Update Submit

February 17, 2025

Conditions

Diabetic Foot UlcerVenous Leg UlcerPressure Ulcer

Outcome Measures

Primary Outcomes (1)

  • Time to complete healing

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

    up to 18 months

Secondary Outcomes (6)

  • Complete healing rate

    4 weeks, 12 weeks

  • Reduction of wound size

    4 weeks, 12 weeks

  • Time to 75% and 50% healing

    up to 18 months

  • 75% and 50% healing rate

    4 weeks, 12 weeks

  • Secondary infections

    up to 18 months

  • +1 more secondary outcomes

Study Arms (2)

Active group

EXPERIMENTAL

Active group will apply ChitoCare medical Wound Healing Gel to the wound in addition to standard of care.

Device: ChitoCare medical Wound Healing Gel

Control group

NO INTERVENTION

Control group will only administer standard of care to treat their wounds.

Interventions

ChitoCare medical Wound Healing GelDEVICE

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

Active group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

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

Zagreb, City of Zagreb, 1000, Croatia

Location

Clinical Hospital Sveti Duh

Zagreb, 1000, Croatia

Location

Marija Poliklinika

Zagreb, 1000, Croatia

Location

Medicina Mataln

Poljčane, Občina Poljčane, 2319, Slovenia

Location

Ordinacija Andrej Kravos

Žalec, Občina Žalec, 3310, Slovenia

Location

General Hospital Celje

Celje, 3000, Slovenia

Location

Health Centre Koper

Koper, 6000, Slovenia

Location

University Clinical Center Maribor

Maribor, 2000, Slovenia

Location

Nursing Home Šmarje pri Jelšah

Šmarje pri Jelšah, 3240, Slovenia

Location

MeSH Terms

Conditions

Diabetic FootVaricose UlcerPressure Ulcer

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesVaricose Veins

Study Officials

  • Helene Liette Lauzon

    Primex ehf

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 7, 2022

Study Start

January 11, 2022

Primary Completion

October 15, 2024

Study Completion

October 15, 2024

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

SL(6)CR(3)