DERMALIX Efficacy on Diabetic Foot Ulcers | NCT03136822

Studies
DERMALIX Efficacy on Diabetic Foot Ulcers

NCT03136822

Sponsor

Dermis Pharma

Status

Completed

Last Update Posted

Aug 3, 2018Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Diabetic Foot
Diabetic Foot Ulcer

Interventions

Standard Dressing
DERMALIX

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 26, 2017Actual

Primary Completion Date

May 2, 2018Actual

Completion Date

Aug 1, 2018Actual

First Submitted Date

Apr 28, 2017

First Submission Date that Met QC Criteria

Apr 28, 2017

First Posted Date

May 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2018

Last Update Posted Date

Aug 3, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Other	Standard dressing	Other: Standard Dressing
Treatment	Experimental	Standard dressing + Wound dressing (DERMALIX)	Other: Standard Dressing Device: DERMALIX

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard Dressing	Other	Standard dressing is applied for treatment of diabetic foot ulcers	Control Treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sevki Cetinkalp, Prof	Ege University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ege University School of Medicine		Izmir		35100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided