DERMALIX Efficacy on Diabetic Foot Ulcers

Not Applicable

Completed

• Conditions: Diabetic Foot; Diabetic Foot Ulcer
• Interventions: Other: Standard Dressing; Device: DERMALIX

• Registration Number: NCT03136822
• Lead Sponsor: Dermis Pharma

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 available

Study Timeline

• Study Start: 2017-04-26
• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-04-28
• Study First Posted: 2017-05-02
• Primary Completion: 2018-05-02
• Status Verified: 2018-08
• Study Completion: 2018-08-01
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	DERMALIX	Standard dressing + Wound dressing (DERMALIX)
Control	Standard Dressing	Standard dressing
Treatment	Standard Dressing	Standard dressing + Wound dressing (DERMALIX)

Primary Outcome Measures

Name	Time	Method
Recovery of the wound 100%	1 month	The wound will be completely recovered

Secondary Outcome Measures

Name	Time	Method
Recovery of the wound 80%	1 month	The wound will be recovered by 80%

Trial Locations

Locations (1)

Ege University School of Medicine; 🇹🇷 Izmir, Turkey