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

A Randomized, Parallel, Double Blind, Placebo Controlled, Multicentre, Two Arms Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds

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.

Study Overview

• Status: Terminated
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: ChitoCare gel; Device: Placebo gel

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • University Clinic Vuk Vrhovac
• Slovenia
  • Celje, Slovenia, 3000
    • General Hospital Celje
  • Kranj, Slovenia, 4000
    • Clinic Golnik - Diabetic Clinic Kranj
  • Ljubljana, Slovenia, 1000
    • University Hospital Center Ljubljana
  • Murska Sobota, Slovenia, 9000
    • General Hospital Murska Sobota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (Experimental group; ChitoCare gel administered topically 2-3 times a week or more (accordingly with the frequency of dressing change)	Device: ChitoCare gel; ChitoCare gel is based on chitosan and used as an addition to standard care, accordingly with dressing change for 10 weeks.
Placebo Comparator: Arm B (Control group); Placebo gel administered topically 2-3 times a week or more (accordingly with the frequency of dressing change)	Device: Placebo gel; Placebo gel is used as an addition to standard care, accordingly with dressing change for 10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in proportion of ulcers completely healed for experimental group compared to the control group	Relative healing rate (ratio between the proportion of ulcers healed for experimental group to the proportion of ulcers healed in control group)	2, 4, 6 and 8 weeks
Difference in reduction of diabetic ulcer wound size for experimental group compared to control group.	Relative reduction of wound surface area.	2, 4, 6, 8, 10 and 14 weeks
Difference in time to complete healing for experimental group compared to control group.	Hazard ratio for time to complete healing (experimental group vs. control group)	Baseline to 14 weeks (whole study duration)
Difference in improved quality of life for experimental group compared to control group.	The relative improvement of quality of life from the baseline value using the 36-Item Short Form Survey (SF-36) questionnaire (RAND Corporation).	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).	The relative improvement of the state of the wound using Bates-Jensen wound assessment tool (BWAT).	2, 4, 6, 8, 10 and 14 weeks
Difference in improved state of the wound for experimental group compared to control group according to Wagner Ulcer Classification.	The relative improvement of the state of the wound using Wagner Ulcer Classification.	2, 4, 6, 8, 10 and 14 weeks
Secondary infections that may occur during the study for experimental group compared to control group.	Occurrence of secondary infection.	Baseline to 14 weeks (whole study duration)
Incidence of treatment related adverse events for experimental group compared to control group.	The incidence of treatment related adverse events.	Baseline to 14 weeks (whole study duration)
To track diabetic ulcer recurrence for experimental group compared to control group in patients whose wound completely healed.	The incidence of diabetic ulcer recurrence.	Baseline to 14 weeks (whole study duration)

Collaborators and Investigators

• Sponsor: Primex ehf
• Collaborators: University of Ljubljana; Vizera d.o.o.
• Investigators: Principal Investigator: Maja Navodnik Preložnik, MD, General Hospital Celje, Slovenia

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2018
• Primary Completion (Actual): September 22, 2020
• Study Completion (Actual): September 22, 2020

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Diabetic foot ulcer; Chronic wounds; Chitosan gel
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: CHITO-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No