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NCT03136822 Clinical Trial

DERMALIX Efficacy on Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

— DERMAN  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03136822
Other study ID # DERMAN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 26, 2017
Est. completion date August 1, 2018

Study information
Verified date August 2018
Source Dermis Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date August 1, 2018
Est. primary completion date May 2, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Standard Dressing
Standard dressing is applied for treatment of diabetic foot ulcers
Device:
• DERMALIX
DERMALIX, a class III Medical Device will be applied in addition to standard dressing

Locations
Country Name City State
Turkey Ege University School of Medicine Izmir

Sponsors (1)
Lead Sponsor Collaborator
Dermis Pharma

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recovery of the wound 100% The wound will be completely recovered 1 month
Secondary Recovery of the wound 80% The wound will be recovered by 80% 1 month
See also
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Active, not recruiting NCT00389636 - TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers N/A
Completed NCT01181440 - Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers Phase 3
Enrolling by invitation NCT05888259 - Plantar Pressure Distribution in Diabetic Foot Ulcer N/A
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Recruiting NCT06037369 - The Short Message-based Customized Standardized N/A
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Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A