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

NCT04178525 | Terminated

• 1 other identifier: CHITO-01
• Study Type: interventional
• Target: 46
• Locations: 2 countries
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Difference in proportions of ulcers completely healed for experimental group compared to control group.

  Relative healing rate (ratio between the proportion of ulcers healed for experimental group to proportion of ulcers healed in control group (= healing rate)).

  10 weeks

Secondary Outcomes (9)

• Difference in proportion of ulcers completely healed for experimental group compared to the control group

  2, 4, 6 and 8 weeks

• Difference in reduction of diabetic ulcer wound size for experimental group compared to control group.

  2, 4, 6, 8, 10 and 14 weeks

• Difference in time to complete healing for experimental group compared to control group.

  Baseline to 14 weeks (whole study duration)

• Difference in improved quality of life for experimental group compared to control group.

  4 weeks and 10 weeks

• Difference in improved state of the wound for experimental group compared to control group using Bates-Jensen wound assessment tool (BWAT).

  2, 4, 6, 8, 10 and 14 weeks

Study Arms (2)

Arm A (Experimental group

EXPERIMENTAL

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

Device: ChitoCare gel

Arm B (Control group)

PLACEBO COMPARATOR

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

Device: Placebo gel

Interventions

ChitoCare gel DEVICE

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

Arm A (Experimental group

Placebo gel DEVICE

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

Arm B (Control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Size of the wound 0,5 - 12 cm\^2
• Wagner grade I or II
• Wound is not infected
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Primex ehf: lead
• Vizera d.o.o.: collaborator
• University of Ljubljana: collaborator

Study Sites (5)

University Clinic Vuk Vrhovac

Zagreb, 10000, Croatia

Location

General Hospital Celje

Celje, 3000, Slovenia

Location

Clinic Golnik - Diabetic Clinic Kranj

Kranj, 4000, Slovenia

Location

University Hospital Center Ljubljana

Ljubljana, 1000, Slovenia

Location

General Hospital Murska Sobota

Murska Sobota, 9000, Slovenia

Location

Related Publications (1)

• 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.

  PMID: 38909998 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Maja Navodnik Preložnik, MD

  General Hospital Celje, Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patients, investigators and other personnel involved in the study will be blinded with respect to the study treatment of the patient, until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization will be applied at a 1:1 ratio on study level, and at each individual site. Sixty (60) patients will be included in the study, 30 in each arm.

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 26, 2019
• Study Start: August 2, 2018
• Primary Completion: September 22, 2020
• Study Completion: September 22, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1); SL (4)