BurnsELSTHERNCT02712580
Therapeutic Effect of the Wireless Micro Current Stimulation in Pediatric Deep Dermal Burns and Scald Injuries
A study testing First investigational device and Second investigational device in people with Burns, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
Trial summary
This study will determine the effect of the wireless micro current stimulation in pediatric deep dermal burns and scald injuries. The clinical trial ist designed as a blinded, placebo-controlled, randomized, prospective, single-center study. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Burns
- What is being tested?
- First investigational device and Second investigational device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Nov 2017
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- inpatients (m / w)
- wound area greater than 0.5% and less than / or equal to 3% of the body surface
- IIb ° combustion depth verified by Laser Doppler Imaging
- Burn / scalds not older than 48 hours
- Participation willingness of the patient
- willingness to participate and written informed consent of both parents (or legal guardian) of the patient
Who cannot join
- known wound healing problems
- child abuse as the cause of the combustion
- different wound dressing treatment prior to transfer to our hospital
Trial locations and contacts
1 site in 1 country.
Germany1 site
Pediatric Surgery Kinder- und Jugendkrankenhaus AUF DER BULT
Hanover, Lower Saxony, 30173
Mechthild Sinnig, MD, 004951181154423, sinnig@hka.de
Katharina Schriek, MD, 004951181154507, schriek@hka.de
About this study
Official title: Clinical Trial for Therapeutic Effect of Wireless Micro Current Stimulation Under Objectification of Combustion Depth by Laser Doppler Imaging in Children and Adolescents With Deep Dermal Burns and Scald Injuries
This study will determine the effect of the wireless micro current stimulation in pediatric deep dermal burns and scald injuries. The clinical trial ist designed as a blinded, placebo-controlled, randomized, prospective, single-center study.
Read the detailed description
Patients (m / w) aged 0-17 years with scalding and burning injuries will initially receive polyhexanide gel 0.02% in the ordinary course.
After 24-48 hours after the accident the wound depth is measured and documented with laser Doppler imaging (see inclusion criteria).
Then the patient is enclosed into the study.
From day 3 after the accident daily dressing changes are performed with possibly slight analgesic medication (ibuprofen 10 mg / kg ) and if necessary under sedation with midazolam 0.5 mg / kg po. Here, a 30-minute-treatment with the wireless micro current stimulation or the placebo lamp is performed.
For visual support of the process of the colorless wireless microcurrent therapy / colorless placebo therapy the medical device has an additional light source (red and white color). So, in addition, both (the control and the placebo) groups are divided in one group with colorless intervention (white light) and a group with red light. The main aspect is to avoid bias.
The treated wound areas are examined daily during the dressing change by the study doctors and standardized photographed.
The condition of the wound is detected in the wound documentation module of KIS. The end point of the wireless micro current stimulation is an epithelialization of the wound surface under investigation of> 95%. The detection of reepithelisation is performed by the investigators and objectified through a photo-image program.
At the total absence of wound healing on day 16th, the patient receives the standard surgical therapy (skin grafting).
If there is an absence of wound healing with less than 50% epithelisation after 3 weeks of wireless micro current stimulation therapy the patient will also receives the standard surgical treatment (skin graft).
If the wound-epithelialisation at day 24 is greater than 50% but not> 95%, the wireless micro current stimulation will still be continued, but no longer than 4 weeks - until day 30.
- Conditions
- Burns
- Being tested
- First investigational device, Second investigational device, ES Wetling W200 Placebo with white light, ES Wetling W200 Placebo with red light
- Keywords
- pediatric burns, deep dermal wounds, wound healing, ChildPain Measurement, Treatment Outcome Wound Healing/physiology, wireless electric stimulation, wireless current stimulation, wireless technology, children, conservative treatment, deep dermal scalds, humans, deep dermal burns, burns, wound healing process
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First investigational deviceDevice
Also called Wireless microcurrent Stimulation Wetling W 200
The irradiation time is 30 minutes a day, the depth of penetration of the electrons in the skin stimulation is 1.5 uA. The irradiation is accompanied by white light.
Second investigational deviceDevice
Also called Wireless microcurrent Stimulation Wetling W 200
The irradiation time is 30 minutes a day, the depth of penetration of the electrons in the skin stimulation is 1.5 uA. The irradiation is accompanied by red light.
ES Wetling W200 Placebo with white lightDevice
Also called non-invasive Electrical Stimulation Lamp
The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by white light.
ES Wetling W200 Placebo with red lightDevice
Also called non-invasive Electrical Stimulation Lamp
The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by red light.
| Study group | Role | What they receive |
|---|---|---|
| First investigational device | Active comparator | official name of product: "Wireless microcurrent Stimulation Wetling W 200" n=47 patients The irradiation time is 30 minutes a day, the depth of penetration of the electrons in the skin stimulation is 1.5 uA. The irradiation is accompanied by white light. Receives: Device: First investigational device |
| Second investigational device | Active comparator | official name of product: "Wireless microcurrent Stimulation Wetling W 200" n=47 patients The irradiation time is 30 minutes a day, the depth of penetration of the electrons in the skin stimulation is 1.5 uA. The irradiation is accompanied by red light. Receives: Device: Second investigational device |
| ES Wetling W200 with white light | Placebo comparator | Placebo device - 'ES Wetling W200 Placebo with white light' n=47 patients The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by white light. Receives: Device: ES Wetling W200 Placebo with white light |
| ES Wetling W200 with red light | Placebo comparator | Placebo device - 'ES Wetling W200 Placebo with red light' n=47 patients The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by red light. Receives: Device: ES Wetling W200 Placebo with red light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelialization of the examined wound area of> 95%
The primary endpoint of the trial is a epithelialization of the examined wound area of> 95%. The primary endpoint is the time to reach a epithelialization of the wound defect> 95%, measured in days since initial treatment (= initial treatment of the wound). In absence of wound healing after initial treatment and study treatment, the then usual surgical treatment for deep dermal wounds will be performed in patients (skin graft).
Measured: up to 30 days
Secondary outcomes (2)
Pain measurements
The secondary endpoints include the subjective pain. This is detected every 8 hours (starting at 8:00 am) during hospitalization and indicated by a validated, visual analogue pain scale through study completion
Measured: up to 21 days
Pain killer consumption
The painkiller consumption per kg / body weight and day is captured through study completion
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kinderkrankenhaus auf der Bult
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mechthild Sinnig, MD, Kinderkrankenhaus auf der Bult
- Investigators
- Mechthild Sinnig, MD, Principal investigator, Kinder- und Jugendkrankenhaus AUF DER BULT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712580
- Sponsor's protocol ID
- 1234567
- Acronym
- ELSTHER
- Status last verified
- Mar 2016
- First submitted
- 4 Jan 2016
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Albertini R, Villaverde AB, Aimbire F, Salgado MA, Bjordal JM, Alves LP, Munin E, Costa MS. Anti-inflammatory effects of low-level laser therapy (LLLT) with two different red wavelengths (660 nm and 684 nm) in carrageenan-induced rat paw edema. J Photochem Photobiol B. 2007 Nov 12;89(1):50-5. doi: 10.1016/j.jphotobiol.2007.08.005. Epub 2007 Sep 6.
PubMed 17920925Cramp AF, Noble JG, Lowe AS, Walsh DM. Transcutaneous electrical nerve stimulation (TENS): the effect of electrode placement upon cutaneous blood flow and skin temperature. Acupunct Electrother Res. 2001;26(1-2):25-37. doi: 10.3727/036012901816356036.
PubMed 11394491Cho MR, Thatte HS, Lee RC, Golan DE. Integrin-dependent human macrophage migration induced by oscillatory electrical stimulation. Ann Biomed Eng. 2000 Mar;28(3):234-43. doi: 10.1114/1.263.
PubMed 10784088Goldman RJ, Brewley BI, Golden MA. Electrotherapy reoxygenates inframalleolar ischemic wounds on diabetic patients: a case series. Adv Skin Wound Care. 2002 May-Jun;15(3):112-20. doi: 10.1097/00129334-200205000-00006.
PubMed 12055444Fiorio FB, Silveira L Jr, Munin E, de Lima CJ, Fernandes KP, Mesquita-Ferrari RA, de Carvalho Pde T, Lopes-Martins RA, Aimbire F, de Carvalho RA. Effect of incoherent LED radiation on third-degree burning wounds in rats. J Cosmet Laser Ther. 2011 Dec;13(6):315-22. doi: 10.3109/14764172.2011.630082.
PubMed 21981305Herberger K, Kornek T, Debus ES, Diener H, Augustin M. Electrotherapy of chronic wounds: evidence of clinical effectiveness and benefit. Wound Manage 2011;2:86 - 93.
Kaada B, Olsen E, Eielsen O. In search of mediators of skin vasodilation induced by transcutaneous nerve stimulation: III. Increase in plasma VIP in normal subjects and in Raynaud's disease. Gen Pharmacol. 1984;15(2):107-13. doi: 10.1016/0306-3623(84)90091-0.
PubMed 6714637Kamolz, Herndon, Jeschke, Verbrennungen: Diagnose, Therapie, Rehabilitation des thermischen Traumas, Springer, Wien New York; 2009; 2, S5- 23
Kloth LC. Electrical stimulation for wound healing: a review of evidence from in vitro studies, animal experiments, and clinical trials. Int J Low Extrem Wounds. 2005 Mar;4(1):23-44. doi: 10.1177/1534734605275733.
PubMed 15860450Mogens, S.; Wirsing, P.; Siemers, F.; Andersen, F. Healing of chronic wound by Wireless Micro Current Stimulation. 2011
Sebastian A, Syed F, Perry D, Balamurugan V, Colthurst J, Chaudhry IH, Bayat A. Acceleration of cutaneous healing by electrical stimulation: degenerate electrical waveform down-regulates inflammation, up-regulates angiogenesis and advances remodeling in temporal punch biopsies in a human volunteer study. Wound Repair Regen. 2011 Nov;19(6):693-708. doi: 10.1111/j.1524-475X.2011.00736.x. Epub 2011 Oct 19.
PubMed 22092840Ud-Din S, Bayat A. Electrical Stimulation and Cutaneous Wound Healing: A Review of Clinical Evidence. Healthcare (Basel). 2014 Oct 27;2(4):445-67. doi: 10.3390/healthcare2040445.
PubMed 27429287Whelan HT, Smits RL Jr, Buchman EV, Whelan NT, Turner SG, Margolis DA, Cevenini V, Stinson H, Ignatius R, Martin T, Cwiklinski J, Philippi AF, Graf WR, Hodgson B, Gould L, Kane M, Chen G, Caviness J. Effect of NASA light-emitting diode irradiation on wound healing. J Clin Laser Med Surg. 2001 Dec;19(6):305-14. doi: 10.1089/104454701753342758.
PubMed 11776448Zhao M, Pu J, Forrester JV, McCaig CD. Membrane lipids, EGF receptors, and intracellular signals colocalize and are polarized in epithelial cells moving directionally in a physiological electric field. FASEB J. 2002 Jun;16(8):857-9. doi: 10.1096/fj.01-0811fje. Epub 2002 Apr 10.
PubMed 11967227Zhao M, Song B, Pu J, Wada T, Reid B, Tai G, Wang F, Guo A, Walczysko P, Gu Y, Sasaki T, Suzuki A, Forrester JV, Bourne HR, Devreotes PN, McCaig CD, Penninger JM. Electrical signals control wound healing through phosphatidylinositol-3-OH kinase-gamma and PTEN. Nature. 2006 Jul 27;442(7101):457-60. doi: 10.1038/nature04925.
PubMed 16871217
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for Therapeutic Effect of Wireless Micro Current Stimulation Under Objectification of Combustion Depth by Laser Doppler Imaging in Children and Adolescents With Deep Dermal Burns and Scald Injuries
- ClinicalTrials.gov ID
- NCT02712580
- Acronym / sponsor ID
- ELSTHER / 1234567
- Conditions
- Burns
- Keywords
- pediatric burns, deep dermal wounds, wound healing, ChildPain Measurement, Treatment Outcome Wound Healing/physiology, wireless electric stimulation, wireless current stimulation, wireless technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Kinderkrankenhaus auf der BultUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 18 Mar 2016 (estimated)
- 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.
This study will determine the effect of the wireless micro current stimulation in pediatric deep dermal burns and scald injuries. The clinical trial ist designed as a blinded, placebo-controlled, randomized, prospective, single-center study.
Detailed description
Patients (m / w) aged 0-17 years with scalding and burning injuries will initially receive polyhexanide gel 0.02% in the ordinary course.
After 24-48 hours after the accident the wound depth is measured and documented with laser Doppler imaging (see inclusion criteria).
Then the patient is enclosed into the study.
From day 3 after the accident daily dressing changes are performed with possibly slight analgesic medication (ibuprofen 10 mg / kg ) and if necessary under sedation with midazolam 0.5 mg / kg po. Here, a 30-minute-treatment with the wireless micro current stimulation or the placebo lamp is performed.
For visual support of the process of the colorless wireless microcurrent therapy / colorless placebo therapy the medical device has an additional light source (red and white color). So, in addition, both (the control and the placebo) groups are divided in one group with colorless intervention (white light) and a group with red light. The main aspect is to avoid bias.
The treated wound areas are examined daily during the dressing change by the study doctors and standardized photographed.
The condition of the wound is detected in the wound documentation module of KIS. The end point of the wireless micro current stimulation is an epithelialization of the wound surface under investigation of> 95%. The detection of reepithelisation is performed by the investigators and objectified through a photo-image program.
At the total absence of wound healing on day 16th, the patient receives the standard surgical therapy (skin grafting).
If there is an absence of wound healing with less than 50% epithelisation after 3 weeks of wireless micro current stimulation therapy the patient will also receives the standard surgical treatment (skin graft).
If the wound-epithelialisation at day 24 is greater than 50% but not> 95%, the wireless micro current stimulation will still be continued, but no longer than 4 weeks - until day 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| First investigational device | Active comparator | Device: First investigational deviceofficial name of product: "Wireless microcurrent Stimulation Wetling W 200" n=47 patients The irradiation time is 30 minutes a day, the depth of penetration of the electrons in the skin stimulation is 1.5 uA. The irradiation is accompanied by white light. |
| Second investigational device | Active comparator | Device: Second investigational deviceofficial name of product: "Wireless microcurrent Stimulation Wetling W 200" n=47 patients The irradiation time is 30 minutes a day, the depth of penetration of the electrons in the skin stimulation is 1.5 uA. The irradiation is accompanied by red light. |
| ES Wetling W200 with white light | Placebo comparator | Device: ES Wetling W200 Placebo with white lightPlacebo device - 'ES Wetling W200 Placebo with white light' n=47 patients The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by white light. |
| ES Wetling W200 with red light | Placebo comparator | Device: ES Wetling W200 Placebo with red lightPlacebo device - 'ES Wetling W200 Placebo with red light' n=47 patients The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by red light. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- inpatients (m / w)
- wound area greater than 0.5% and less than / or equal to 3% of the body surface
- IIb ° combustion depth verified by Laser Doppler Imaging
- Burn / scalds not older than 48 hours
- Participation willingness of the patient
Key exclusion criteria (3 listed)
- known wound healing problems
- child abuse as the cause of the combustion
- different wound dressing treatment prior to transfer to our hospital
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 |
|---|---|---|
| First investigational deviceAlso: Wireless microcurrent Stimulation Wetling W 200The irradiation time is 30 minutes a day, the depth of penetration of the electrons in the skin stimulation is 1.5 uA. The irradiation is accompanied by white light. | Device | First investigational device |
| Second investigational deviceAlso: Wireless microcurrent Stimulation Wetling W 200The irradiation time is 30 minutes a day, the depth of penetration of the electrons in the skin stimulation is 1.5 uA. The irradiation is accompanied by red light. | Device | Second investigational device |
| ES Wetling W200 Placebo with white lightAlso: non-invasive Electrical Stimulation LampThe placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by white light. | Device | ES Wetling W200 with white light |
| ES Wetling W200 Placebo with red lightAlso: non-invasive Electrical Stimulation LampThe placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by red light. | Device | ES Wetling W200 with red light |
Primary outcome
Epithelialization of the examined wound area of> 95%
Time frame: up to 30 days
The primary endpoint of the trial is a epithelialization of the examined wound area of> 95%. The primary endpoint is the time to reach a epithelialization of the wound defect> 95%, measured in days since initial treatment (= initial treatment of the wound). In absence of wound healing after initial treatment and study treatment, the then usual surgical treatment for deep dermal wounds will be performed in patients (skin graft).
2 secondary outcomes
Pain measurements
Time frame: up to 21 days
Pain killer consumption
Time frame: up to 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- Background: PubMed 17920925Albertini R, Villaverde AB, Aimbire F, Salgado MA, Bjordal JM, Alves LP, Munin E, Costa MS. Anti-inflammatory effects of low-level laser therapy (LLLT) with two different red wavelengths (660 nm and 684 nm) in carrageenan-induced rat paw edema. J Photochem Photobiol B. 2007 Nov 12;89(1):50-5. doi: 10.1016/j.jphotobiol.2007.08.005. Epub 2007 Sep 6.
- Background: PubMed 11394491Cramp AF, Noble JG, Lowe AS, Walsh DM. Transcutaneous electrical nerve stimulation (TENS): the effect of electrode placement upon cutaneous blood flow and skin temperature. Acupunct Electrother Res. 2001;26(1-2):25-37. doi: 10.3727/036012901816356036.
- Background: PubMed 10784088Cho MR, Thatte HS, Lee RC, Golan DE. Integrin-dependent human macrophage migration induced by oscillatory electrical stimulation. Ann Biomed Eng. 2000 Mar;28(3):234-43. doi: 10.1114/1.263.
- Background: PubMed 12055444Goldman RJ, Brewley BI, Golden MA. Electrotherapy reoxygenates inframalleolar ischemic wounds on diabetic patients: a case series. Adv Skin Wound Care. 2002 May-Jun;15(3):112-20. doi: 10.1097/00129334-200205000-00006.
- Background: PubMed 21981305Fiorio FB, Silveira L Jr, Munin E, de Lima CJ, Fernandes KP, Mesquita-Ferrari RA, de Carvalho Pde T, Lopes-Martins RA, Aimbire F, de Carvalho RA. Effect of incoherent LED radiation on third-degree burning wounds in rats. J Cosmet Laser Ther. 2011 Dec;13(6):315-22. doi: 10.3109/14764172.2011.630082.
- BackgroundHerberger K, Kornek T, Debus ES, Diener H, Augustin M. Electrotherapy of chronic wounds: evidence of clinical effectiveness and benefit. Wound Manage 2011;2:86 - 93.
- Background: PubMed 6714637Kaada B, Olsen E, Eielsen O. In search of mediators of skin vasodilation induced by transcutaneous nerve stimulation: III. Increase in plasma VIP in normal subjects and in Raynaud's disease. Gen Pharmacol. 1984;15(2):107-13. doi: 10.1016/0306-3623(84)90091-0.
- BackgroundKamolz, Herndon, Jeschke, Verbrennungen: Diagnose, Therapie, Rehabilitation des thermischen Traumas, Springer, Wien New York; 2009; 2, S5- 23
- Background: PubMed 15860450Kloth LC. Electrical stimulation for wound healing: a review of evidence from in vitro studies, animal experiments, and clinical trials. Int J Low Extrem Wounds. 2005 Mar;4(1):23-44. doi: 10.1177/1534734605275733.
- BackgroundMogens, S.; Wirsing, P.; Siemers, F.; Andersen, F. Healing of chronic wound by Wireless Micro Current Stimulation. 2011
- Background: PubMed 22092840Sebastian A, Syed F, Perry D, Balamurugan V, Colthurst J, Chaudhry IH, Bayat A. Acceleration of cutaneous healing by electrical stimulation: degenerate electrical waveform down-regulates inflammation, up-regulates angiogenesis and advances remodeling in temporal punch biopsies in a human volunteer study. Wound Repair Regen. 2011 Nov;19(6):693-708. doi: 10.1111/j.1524-475X.2011.00736.x. Epub 2011 Oct 19.
- Background: PubMed 27429287Ud-Din S, Bayat A. Electrical Stimulation and Cutaneous Wound Healing: A Review of Clinical Evidence. Healthcare (Basel). 2014 Oct 27;2(4):445-67. doi: 10.3390/healthcare2040445.
- Individual participant dataSharing planned: No
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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.
Mechthild Sinnig, MD principal investigator
Kinder- und Jugendkrankenhaus AUF DER BULT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First investigational device and Second investigational device in people with Burns, run by Kinderkrankenhaus auf der Bult at 1 site in Germany.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Mar 2016. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mechthild Sinnig, MD (004951181154423, sinnig@hka.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epithelialization of the examined wound area of> 95% (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02712580, which also lists 15 linked publications.
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 18 Mar 2016.