DERMALIX Efficacy on Diabetic Foot Ulcers (DERMAN)

August 2, 2018 updated by: Dermis Pharma

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

(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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Izmir, Turkey, 35100
        • Ege University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Standard dressing
Other: Standard Dressing
Standard dressing is applied for treatment of diabetic foot ulcers
Experimental: Treatment
Standard dressing + Wound dressing (DERMALIX)
Other: Standard Dressing
Standard dressing is applied for treatment of diabetic foot ulcers
Device: DERMALIX
DERMALIX, a class III Medical Device will be applied in addition to standard dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery of the wound 100%
Time Frame: 1 month
The wound will be completely recovered
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery of the wound 80%
Time Frame: 1 month
The wound will be recovered by 80%
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dermis Pharma

Investigators

  • Principal Investigator: Sevki Cetinkalp, Prof, Ege University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2017

Primary Completion (Actual)

May 2, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

April 28, 2017

First Submitted That Met QC Criteria

April 28, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DERMAN

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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