DERMALIX Efficacy on Diabetic Foot Ulcers (DERMAN)

Dermis Pharma

Status: Completed

Conditions: Diabetic Foot; Diabetic Foot Ulcer

Treatments: Other: Standard Dressing; Device: DERMALIX

Study type: Interventional

Funder types: Industry

Identifiers

NCT03136822

DERMAN

Details and patient eligibility

About

(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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Control

Other group

Description:

Standard dressing

Treatment:

Other: Standard Dressing

Treatment

Experimental group

Description:

Standard dressing + Wound dressing (DERMALIX)

Treatment:

Other: Standard Dressing

Device: DERMALIX