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

NCT04178525 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-11-13

No results posted yet for this study

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

Interventions

DEVICE

ChitoCare gel

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

DEVICE

Placebo gel

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

Sponsors & Collaborators

  • Vizera d.o.o.

    collaborator INDUSTRY

  • University of Ljubljana

    collaborator OTHER

  • Primex ehf

    lead INDUSTRY

Principal Investigators

  • Maja Navodnik Preložnik, MD · General Hospital Celje, Slovenia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-02
Primary Completion
2020-09-22
Completion
2020-09-22

Countries

  • Croatia
  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04178525 on ClinicalTrials.gov