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

Primex ehf5 sites in 2 countries46 target enrollmentAugust 2, 2018

ConditionsDiabetic Foot Ulcer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Foot Ulcer
Sponsor: Primex ehf
Enrollment: 46
Locations: 5
Primary Endpoint: Difference in proportions of ulcers completely healed for experimental group compared to control group.
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2, 2018

End Date

September 22, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Primex ehf

Responsible Party

Sponsor

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:
•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

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.

Outcomes

Primary Outcomes

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

Time Frame: 10 weeks

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

Secondary Outcomes

Difference in time to complete healing for experimental group compared to control group.(Baseline to 14 weeks (whole study duration))
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 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)
Secondary infections that may occur during the study for experimental group compared to control group.(Baseline to 14 weeks (whole study duration))
Difference in improved state of the wound for experimental group compared to control group according to Wagner Ulcer Classification.(2, 4, 6, 8, 10 and 14 weeks)
Incidence of treatment related adverse events for experimental group compared to control group.(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.(Baseline to 14 weeks (whole study duration))