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Completed

NCT Number: NCT03136822

DERMALIX Efficacy 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.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Ulcer Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University School of Medicine

Izmir, 35100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard dressing

Other

Standard dressing is applied for treatment of diabetic foot ulcers

DERMALIX

Device

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

Primary outcomes

  1. Recovery of the wound 100%

    Time frame: 1 month

    The wound will be completely recovered

Secondary outcomes

  1. Recovery of the wound 80%

    Time frame: 1 month

    The wound will be recovered by 80%

Sponsors and collaborators

Lead sponsor

Dermis Pharma

Industry

Registry information

Official study title

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

Acronym: DERMAN

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 2, 2017
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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