|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03136822 |
|
Date of registration:
|
28/04/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
DERMALIX Efficacy on Diabetic Foot Ulcers
DERMAN |
|
Scientific title:
|
Clinical Evaluation of the Wound Dressing Impregnated With Microparticules (DERMALIX) on Diabetic Foot Ulcers |
|
Date of first enrolment:
|
April 26, 2017 |
|
Target sample size:
|
48 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03136822 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Turkey
| | | | | | | |
|
Contacts
|
|
Name:
|
Sevki Cetinkalp, Prof |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Ege University School of Medicine |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetic Foot
|
|
Diabetic Foot Ulcer
|
|
Intervention(s)
|
|
Other: Standard Dressing
|
|
Device: DERMALIX
|
|
Primary Outcome(s)
|
|
Recovery of the wound 100%
[Time Frame: 1 month]
|
|
Secondary Outcome(s)
|
|
Recovery of the wound 80%
[Time Frame: 1 month]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|