Clinical Evaluation of the Wound Dressing Impregnated With Microparticules (DERMALIX) on Diabetic Foot Ulcers

Dermis Pharma1 site in 1 country48 target enrollmentApril 26, 2017

ConditionsDiabetic Foot Diabetic Foot Ulcer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Foot
Sponsor: Dermis Pharma
Enrollment: 48
Locations: 1
Primary Endpoint: Recovery of the wound 100%
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

(DERMALIX) (Patent number: PCT/TR2014/000251) is a bioactive wound dressing that was developed by Ege University School of Pharmacy Department of Pharmaceutical Technology. This dressing has been categorised as Class III medical device. This clinical study will be conducted in patients with diabetic foot ulcers.

Registry

clinicaltrials.gov

Start Date

April 26, 2017

End Date

August 1, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dermis Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Type 1 or 2 Patients diagnosed with diabetic foot ulcers
•Class I and II according to Wagner classification
•No infections confirmed with culture test
•No osteomyelitis and gangrene in the foot
•HbA1c values ≤ % 7.5
•Not active smoker
•No planned treatment of hyperbaric oxygen
•Patients who give consent for the study

Exclusion Criteria

•Patients with diabetic foot ulcer of class 3,4 and 5 according to Wagner classification
•Patients who are pregnant or breast-feeding or female who are in reproductive age applying no preservative method
•Patients who have mental conditions that lead to difficulties in comprehension
•Patients who may have compliance issues
•Patients who have been included to another interventional study with drug or medical device