Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds

NCT ID: NCT04178525

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-02
• Study Completion Date: 2020-09-22

Brief Summary

Type 1 and Type 2 diabetic patients with diabetic foot ulcer will be recruited and screened for participation in the study. Eligible patients will be randomized 1:1 to either experimental or control group and undergo 10-weeks of treatment (as an addition to standard care) and 4 weeks of follow-up to evaluate the effect of chitosan gel on chronic wound (diabetic foot ulcer) healing.

Conditions

Diabetic Foot Ulcer

Keywords

Chronic wounds; Diabetic foot ulcer; Chitosan gel

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm A (Experimental group

ChitoCare gel administered topically 2-3 times a week or more (accordingly with the frequency of dressing change)

Group Type: EXPERIMENTAL

ChitoCare gel

Intervention Type: DEVICE

ChitoCare gel is based on chitosan and used as an addition to standard care, accordingly with dressing change for 10 weeks.

Arm B (Control group)

Placebo gel administered topically 2-3 times a week or more (accordingly with the frequency of dressing change)

Group Type: PLACEBO_COMPARATOR

Placebo gel

Intervention Type: DEVICE

Placebo gel is used as an addition to standard care, accordingly with dressing change for 10 weeks.

Interventions

ChitoCare gel

ChitoCare gel is based on chitosan and used as an addition to standard care, accordingly with dressing change for 10 weeks.

Intervention Type: DEVICE

Placebo gel

Placebo gel is used as an addition to standard care, accordingly with dressing change for 10 weeks.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Written informed consent must be given
• Patient ≥ 18 years old
• Diagnosed with type I or type II diabetes mellitus
• Glycosylated haemoglobin, HbA1c, ≤ 12%
• Presence of diabetic foot ulcer or an amputation wound that meets following criteria:

1. Size of the wound 0,5 - 12 cm^2

2. Wagner grade I or II

3. Wound is not infected

4. Wound present for at least 4 weeks

• If multiple wounds are present, the biggest wound fitting the criteria is selected and the distance from other wounds must be at least 2 cm
• If there is an amputation wound present, it can be used for the purpose of this study if it fits the rest of the criteria
• Adequate perfusion (good, strong foot pulses). If foot pulses are weak, evaluation of perfusion pressures with Doppler ultrasound is performed.
• Able to understand and comply with the requirements of the trial

Exclusion Criteria

• Known history of alcohol or drug abuse
• Use of any antibiotic medication within the last 7 days prior to the first application of study product
• Patients presenting with Wagner Grade III or higher ulcer
• Patients with serious concomitant disease (cancer, heart failure ( NYHA class IV), severe anemia (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 doctor
• Excessive lymphedema that could interfere with wound healing (if there is mild edema treated with compression therapy the patient can be included)
• Patients diagnosed with autoimmune connective tissues diseases
• Previous treatment under this clinical protocol
• Participation in another clinical trial up to 30 days before the randomization visit.
• 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
• Medical condition likely to require systemic corticosteroids during the study period
• Allergic to shellfish, chitosan or one of ChitoCare product compounds
• Immobile patients
• Pregnant and lactating women
• Significant increase in wound healing during run-in period (reduction of wound size area ≥ 40%)
• BMI > 39 kg/m2

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vizera d.o.o.

INDUSTRY

Sponsor Role: collaborator

University of Ljubljana

OTHER

Sponsor Role: collaborator

Primex ehf

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maja Navodnik Preložnik, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital Celje, Slovenia

Locations

University Clinic Vuk Vrhovac

Zagreb, , Croatia

General Hospital Celje

Celje, , Slovenia

Clinic Golnik - Diabetic Clinic Kranj

Kranj, , Slovenia

University Hospital Center Ljubljana

Ljubljana, , Slovenia

General Hospital Murska Sobota

Murska Sobota, , Slovenia

Countries

Croatia; Slovenia

References

Slivnik M, Navodnik Preloznik M, Fir M, Jazbar J, Cebron Lipovec N, Locatelli I, Liette Lauzon H, Urbancic Rovan V. A randomized, placebo-controlled study of chitosan gel for the treatment of chronic diabetic foot ulcers (the CHITOWOUND study). BMJ Open Diabetes Res Care. 2024 Jun 23;12(3):e004195. doi: 10.1136/bmjdrc-2024-004195.

Reference Type: DERIVED

PMID: 38909998 (View on PubMed)

Other Identifiers

CHITO-01

Identifier Type: -

Identifier Source: org_study_id