DERMALIX Efficacy on Diabetic Foot Ulcers

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03136822

Acronym

DERMAN

Enrollment

Registered

2017-05-02

Start date

2017-04-26

Completion date

2018-08-01

Last updated

2018-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot, Diabetic Foot Ulcer

Keywords

Diabetic Foot

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.

Interventions

OTHERStandard Dressing

Standard dressing is applied for treatment of diabetic foot ulcers

DEVICEDERMALIX

DERMALIX, a class III Medical Device will be applied in addition to standard dressing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

The wound will be assessed by Pathologists who are masked for treatment

Intervention model description

Open label, controlled, randomised, parallel arm study

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026