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DERMALIX Efficacy on Diabetic Foot Ulcers (DERMAN)

Primary Purpose

Diabetic Foot, Diabetic Foot Ulcer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Standard Dressing
DERMALIX
Sponsored by
Dermis Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring Diabetic Foot

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ege University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Treatment

Arm Description

Standard dressing

Standard dressing + Wound dressing (DERMALIX)

Outcomes

Primary Outcome Measures

Recovery of the wound 100%
The wound will be completely recovered

Secondary Outcome Measures

Recovery of the wound 80%
The wound will be recovered by 80%

Full Information

First Posted
April 28, 2017
Last Updated
August 2, 2018
Sponsor
Dermis Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03136822
Brief Title
DERMALIX Efficacy on Diabetic Foot Ulcers
Acronym
DERMAN
Official Title
Clinical Evaluation of the Wound Dressing Impregnated With Microparticules (DERMALIX) on Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 26, 2017 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermis Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Diabetic Foot Ulcer
Keywords
Diabetic Foot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open label, controlled, randomised, parallel arm study
Masking
Outcomes Assessor
Masking Description
The wound will be assessed by Pathologists who are masked for treatment
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Standard dressing
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Standard dressing + Wound dressing (DERMALIX)
Intervention Type
Other
Intervention Name(s)
Standard Dressing
Intervention Description
Standard dressing is applied for treatment of diabetic foot ulcers
Intervention Type
Device
Intervention Name(s)
DERMALIX
Intervention Description
DERMALIX, a class III Medical Device will be applied in addition to standard dressing
Primary Outcome Measure Information:
Title
Recovery of the wound 100%
Description
The wound will be completely recovered
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Recovery of the wound 80%
Description
The wound will be recovered by 80%
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevki Cetinkalp, Prof
Organizational Affiliation
Ege University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University School of Medicine
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

DERMALIX Efficacy on Diabetic Foot Ulcers

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