DERMALIX Efficacy on Diabetic Foot Ulcers

NCT03136822 | Completed

• 1 other identifier: DERMAN
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Diabetic Foot Ulcer

Keywords

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

• Recovery of the wound 100%

  The wound will be completely recovered

  1 month

Secondary Outcomes (1)

• Recovery of the wound 80%

  1 month

Study Arms (2)

Control

OTHER

Standard dressing

Other: Standard Dressing

Treatment

EXPERIMENTAL

Standard dressing + Wound dressing (DERMALIX)

Other: Standard Dressing; Device: DERMALIX

Interventions

Standard Dressing OTHER

Standard dressing is applied for treatment of diabetic foot ulcers

Control; Treatment

DERMALIX DEVICE

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

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dermis Pharma: lead

Study Sites (1)

Ege University School of Medicine

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Officials

• Sevki Cetinkalp, Prof

  Ege University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The wound will be assessed by Pathologists who are masked for treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, controlled, randomised, parallel arm study

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 2, 2017
• Study Start: April 26, 2017
• Primary Completion: May 2, 2018
• Study Completion: August 1, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)