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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: ChitoCare gel
* Device: Placebo gel


Participation Criteria
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Eligibility Criteria
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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: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic wounds, Diabetic foot ulcer, Chitosan gel