Diabetic FootDERMANNCT03136822
DERMALIX Efficacy on Diabetic Foot Ulcers
A study testing Standard Dressing and DERMALIX in people with Diabetic Foot and Diabetic Foot Ulcer, run by Dermis Pharma at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot, Diabetic Foot Ulcer
- What is being tested?
- Standard Dressing and DERMALIX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Apr 2017to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Medicine
Izmir, 35100
About this study
Official title: Clinical Evaluation of the Wound Dressing Impregnated With Microparticules (DERMALIX) on Diabetic Foot Ulcers
(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
- Being tested
- Standard Dressing, DERMALIX
- Keywords
- Diabetic Foot
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard DressingOther
Standard dressing is applied for treatment of diabetic foot ulcers
DERMALIXDevice
DERMALIX, a class III Medical Device will be applied in addition to standard dressing
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Standard dressing Receives: Other: Standard Dressing |
| Treatment | Experimental | Standard dressing + Wound dressing (DERMALIX) Receives: Other: Standard Dressing; Device: DERMALIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of the wound 100%
The wound will be completely recovered
Measured: 1 month
Secondary outcomes (1)
Recovery of the wound 80%
The wound will be recovered by 80%
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start26 Apr 2017
- Primary completion2 May 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, controlled, randomised, parallel arm study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermis Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sevki Cetinkalp, Prof, Principal investigator, Ege University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136822
- Sponsor's protocol ID
- DERMAN
- Acronym
- DERMAN
- Status last verified
- Aug 2018
- First submitted
- 28 Apr 2017
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Wound Dressing Impregnated With Microparticules (DERMALIX) on Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03136822
- Acronym / sponsor ID
- DERMAN / DERMAN
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer
- Keywords
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dermis PharmaIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Open label, controlled, randomised, parallel arm study
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Standard DressingStandard dressing |
| Treatment | Experimental | Other: Standard Dressing, Device: DERMALIXStandard dressing + Wound dressing (DERMALIX) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard DressingStandard dressing is applied for treatment of diabetic foot ulcers | Other | Control, Treatment |
| DERMALIXDERMALIX, a class III Medical Device will be applied in addition to standard dressing | Device | Treatment |
Primary outcome
Recovery of the wound 100%
Time frame: 1 month
The wound will be completely recovered
1 secondary outcome
Recovery of the wound 80%
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Individual participant dataSharing planned: No
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Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
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Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevki Cetinkalp, Prof principal investigator
Ege University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Dressing and DERMALIX in people with Diabetic Foot and Diabetic Foot Ulcer, run by Dermis Pharma at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of the wound 100% (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.