AgeRESOLVENCT01040104
Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals
An observational study of Age and Cicatrix, Hypertrophic, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Regular wound healing follows a well-ordered sequence of overlapping phases: inflammation, proliferation, maturation and remodelling. In the young, damage to an organ mostly triggers fully regenerative mechanisms called "primary" wound healing. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Age, Cicatrix, Hypertrophic, Fibrosis
- What is being tested?
- Skin sample, Skin biopsy and Blood taking
- How many people
- 51 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2009to Jul 2011
- Phase
- Observational
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: WP 2.1 Individuals due for planned elective plastic surgery with regular wound healing WP 2.2 Individuals, who suffered from burns, trauma or having undergone any type of previous surgery with and without hypertrophic scar formation WP 2.4 Individuals, who require split-thickness skin grafting for skin defects with or without diabetes mellitus
Who may be able to join
- age 18-45 and 55-85 years, respectively
- age 18-45 and 55-85 years, respectively
- normal and/or hypertrophic scars
- Baux score <100
- age 18-45 and 55-85 years, respectively
Who cannot join
- past medical history of hypertrophic scarring or keloid disease
- cardiac disease adversely affecting peripheral blood flow
- active neoplastic disease
- immunosuppressive condition, congenital or acquired
- anemia
- autoimmune disorder
Show all 38Show fewer
- acute or chronic renal failure
- liver cirrhosis or active hepatitis
- active substance-abuse disorder
- severe underweight (body mass index <16)
- endocrinological disorder
- pregnancy or lactation for women of child-bearing age
- WP2.2
- sepsis
- electrical and/or chemical burn
- clinically significant wound infection in areas of planned biopsies
- cardiac disease adversely affecting peripheral blood flow
- active neoplastic disease
- immunosuppressive condition, congenital or acquired
- autoimmune disorder
- acute or chronic renal failure
- liver cirrhosis or active hepatitis
- active substance-abuse disorder
- severe underweight (body mass index <16)
- endocrinological disorder
- pregnancy or lactation for women of child-bearing age
- WP 2.4
- cardiac disease adversely affecting peripheral blood flow
- active neoplastic disease
- immunosuppressive condition, congenital or acquired
- anemia
- autoimmune disorder
- acute or chronic renal failure
- liver cirrhosis or active hepatitis
- substance-abuse disorder
- severe underweight (body mass index <16)
- thyroid function disorder
- pregnancy or lactation for women of child-bearing age
Trial locations and contacts
1 site in 1 country.
Austria1 site
Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
Official title: Pilot Study of Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals
Regular wound healing follows a well-ordered sequence of overlapping phases: inflammation, proliferation, maturation and remodelling.
In the young, damage to an organ mostly triggers fully regenerative mechanisms called "primary" wound healing. Repeated damage in young individuals may cause "secondary" wound healing eg. scar formation reflecting a rescue program, in which reorganisation has failed.
Read more
Organ failure in the ageing organism is characterized by a progressive loss of its capability to achieve an orderly reactivation of organ repair, and results in a combination of chronic inflammation and fibroproliferative, non-regenerative repair affecting several organs, including lung, liver and skin.
RESOLVE's objective is to identify, characterize, and validate molecular targets responsible for shifting primary organ repair towards fibroproliferative wound healing as a result of an age-dependent loss of regulatory control.
The structured approach is based on
- different forms of wound healing,
- different human diseases and
- different genetic backgrounds, aiming to provide future diagnostic tools in various organs, to create transgenic animal test systems, and to identify molecular targets involved in fibroproliferative wound healing.
Read the detailed description
Cutaneous scars are frequently encountered conditions. The process of wound repair, however, is complicated, and various factors contribute to different types of scarring (eg. hypertrophic, atrophic).
WP 2.1: Regular skin repair
In elective plastic surgery most excised operative skin specimens are usually discarded, and represent an excellent opportunity of harvesting skin biopsies without additional invasive measures. This work package analyzes skin samples of individuals after elective plastic surgery with normal wound healing serving as control group.
WP 2.2: Skin repair with and without hypertrophic scar formation
A classic example of fibroproliferative repair in the skin is hypertrophic scarring classified as a dermal skin lesion, which is raised above skin level, stays within the confines of the initial wound and increases in size by pushing out the margins of the scar without invading the surrounding normal tissue.
Hypertrophic scarring is a condition commonly observed after burns and in regions of prolonged wound healing (>21 days). The underlying pathology of hypertrophic scarring, however, is poorly understood. Hypertrophic scars can be managed conservatively, and only require surgical intervention under special circumstances.
This work package analyzes the clinical and molecular response to a standard treatment regimen in skin regions with and without hypertrophic scars after skin injuries.
WP 2.4: Wound healing in normal and diabetic individuals
Diabetes mellitus is a known factor to cause impaired wound healing. Due to microangiopathic, macroangiopathic and other conditions resulting from atherosclerosis and peripheral neuropathy wound healing in diabetic individuals is usually delayed (hypotrophic, atrophic) and often complicated by immunosuppression and superinfections. The rising prevalence of diabetes mellitus in the elderly population makes it necessary to understand its related processes in relevant clinical wound models.
Split-thickness skin-grafting is a commonly applied technique in plastic surgery, and donor sites of previously uninjured skin regions spontaneously heal within two weeks, representing an ideal condition to monitor clinical and molecular changes in diseased vs. non-diseased states.
This work package analyzes skin repair in donor sites of split-thickness skin grafts in non-diabetic and diabetic individuals.
- Conditions
- Age, Cicatrix, Hypertrophic, Fibrosis, Diabetes Mellitus
- Being tested
- Skin sample, Skin biopsy, Blood taking
- Keywords
- wound healing, hypertrophic scar, skin transplantation, diabetes mellitus
- Medical subject headings
- Cicatrix, Hypertrophic, Fibrosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin sampleOther
Taken from regularly discarded tissue during routine operation
Skin biopsyOther
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Skin biopsyOther
Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90
Blood takingOther
Blood taking on day 0
Blood takingOther
Blood taking on day 90
| Study group | Role | What they receive |
|---|---|---|
| Regular wound healing, young | Regular skin repair, controlled wound healing conditions in young individuals Receives: Other: Skin sample; Other: Blood taking | |
| Regular wound healing, aged | Regular skin repair, controlled wound healing conditions in aged individuals Receives: Other: Skin sample; Other: Blood taking | |
| Hypertrophic scarring, young | Skin repair with and without hypertrophic scarring in young individuals Receives: Other: Skin biopsy; Other: Blood taking | |
| Hypertrophic scarring, aged | Skin repair with and without hypertrophic scarring in aged individuals Receives: Other: Skin biopsy; Other: Blood taking | |
| Non-diabetic, young | Skin repair in non-diabetic young individuals Receives: Other: Skin biopsy; Other: Blood taking | |
| Non-diabetic, aged | Skin repair in non-diabetic aged individuals Receives: Other: Skin biopsy; Other: Blood taking | |
| Diabetic, young | Skin repair in young diabetic individuals Receives: Other: Skin biopsy; Other: Blood taking | |
| Diabetic, aged | Skin repair in aged diabetic individuals Receives: Other: Skin biopsy; Other: Blood taking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to wound healing / Scar maturation
Measured: day14, day90, day180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AgeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Principal investigator, David Lumenta, MD, Medical University of Vienna
- Investigators
- Lars P Kamolz, MD, MSc, Principal investigator, MUW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040104
- Sponsor's protocol ID
- FP7-202047.WP.2.1-2.2-2.4
- Other IDs
- MUW-EK-Nr_015/2009
- Acronym
- RESOLVE
- Status last verified
- Nov 2013
- First submitted
- 28 Dec 2009
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gangemi EN, Gregori D, Berchialla P, Zingarelli E, Cairo M, Bollero D, Ganem J, Capocelli R, Cuccuru F, Cassano P, Risso D, Stella M. Epidemiology and risk factors for pathologic scarring after burn wounds. Arch Facial Plast Surg. 2008 Mar-Apr;10(2):93-102. doi: 10.1001/archfaci.10.2.93.
PubMed 18347236Izadi K, Ganchi P. Chronic wounds. Clin Plast Surg. 2005 Apr;32(2):209-22. doi: 10.1016/j.cps.2004.11.011.
PubMed 15814118Blakytny R, Jude E. The molecular biology of chronic wounds and delayed healing in diabetes. Diabet Med. 2006 Jun;23(6):594-608. doi: 10.1111/j.1464-5491.2006.01773.x.
PubMed 16759300Komesu MC, Tanga MB, Buttros KR, Nakao C. Effects of acute diabetes on rat cutaneous wound healing. Pathophysiology. 2004 Oct;11(2):63-67. doi: 10.1016/j.pathophys.2004.02.002.
PubMed 15364115Niessen FB, Spauwen PH, Schalkwijk J, Kon M. On the nature of hypertrophic scars and keloids: a review. Plast Reconstr Surg. 1999 Oct;104(5):1435-58. doi: 10.1097/00006534-199910000-00031. No abstract available.
PubMed 10513931Rockwell WB, Cohen IK, Ehrlich HP. Keloids and hypertrophic scars: a comprehensive review. Plast Reconstr Surg. 1989 Nov;84(5):827-37. doi: 10.1097/00006534-198911000-00021. No abstract available.
PubMed 2682703Gottrup F, Agren MS, Karlsmark T. Models for use in wound healing research: a survey focusing on in vitro and in vivo adult soft tissue. Wound Repair Regen. 2000 Mar-Apr;8(2):83-96. doi: 10.1046/j.1524-475x.2000.00083.x.
PubMed 10810034Ashcroft GS, Mills SJ, Ashworth JJ. Ageing and wound healing. Biogerontology. 2002;3(6):337-45. doi: 10.1023/a:1021399228395.
PubMed 12510172Gosain A, DiPietro LA. Aging and wound healing. World J Surg. 2004 Mar;28(3):321-6. doi: 10.1007/s00268-003-7397-6. Epub 2004 Feb 17.
PubMed 14961191Crooks A. How does ageing affect the wound healing process? J Wound Care. 2005 May;14(5):222-3. doi: 10.12968/jowc.2005.14.5.26777.
PubMed 15909438Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J. Hypertrophic burn scars: analysis of variables. J Trauma. 1983 Oct;23(10):895-8.
PubMed 6632013Bombaro KM, Engrav LH, Carrougher GJ, Wiechman SA, Faucher L, Costa BA, Heimbach DM, Rivara FP, Honari S. What is the prevalence of hypertrophic scarring following burns? Burns. 2003 Jun;29(4):299-302. doi: 10.1016/s0305-4179(03)00067-6.
PubMed 12781605Oliveira GV, Chinkes D, Mitchell C, Oliveras G, Hawkins HK, Herndon DN. Objective assessment of burn scar vascularity, erythema, pliability, thickness, and planimetry. Dermatol Surg. 2005 Jan;31(1):48-58. doi: 10.1111/j.1524-4725.2005.31004.
PubMed 15720096Mustoe TA, Cooter RD, Gold MH, Hobbs FD, Ramelet AA, Shakespeare PG, Stella M, Teot L, Wood FM, Ziegler UE; International Advisory Panel on Scar Management. International clinical recommendations on scar management. Plast Reconstr Surg. 2002 Aug;110(2):560-71. doi: 10.1097/00006534-200208000-00031.
PubMed 12142678
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals
- ClinicalTrials.gov ID
- NCT01040104
- Acronym / sponsor ID
- RESOLVE / FP7-202047.WP.2.1-2.2-2.4
- Conditions
- Age, Cicatrix, Hypertrophic, Fibrosis, Diabetes Mellitus
- Keywords
- wound healing, hypertrophic scar, skin transplantation, diabetes mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- European Union
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (actual)
- First posted
- 29 Dec 2009 (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.
Regular wound healing follows a well-ordered sequence of overlapping phases: inflammation, proliferation, maturation and remodelling.
In the young, damage to an organ mostly triggers fully regenerative mechanisms called "primary" wound healing. Repeated damage in young individuals may cause "secondary" wound healing eg. scar formation reflecting a rescue program, in which reorganisation has failed.
Organ failure in the ageing organism is characterized by a progressive loss of its capability to achieve an orderly reactivation of organ repair, and results in a combination of chronic inflammation and fibroproliferative, non-regenerative repair affecting several organs, including lung, liver and skin.
RESOLVE's objective is to identify, characterize, and validate molecular targets responsible for shifting primary organ repair towards fibroproliferative wound healing as a result of an age-dependent loss of regulatory control.
The structured approach is based on
- different forms of wound healing,
- different human diseases and
- different genetic backgrounds, aiming to provide future diagnostic tools in various organs, to create transgenic animal test systems, and to identify molecular targets involved in fibroproliferative wound healing.
Detailed description
Cutaneous scars are frequently encountered conditions. The process of wound repair, however, is complicated, and various factors contribute to different types of scarring (eg. hypertrophic, atrophic).
WP 2.1: Regular skin repair
In elective plastic surgery most excised operative skin specimens are usually discarded, and represent an excellent opportunity of harvesting skin biopsies without additional invasive measures. This work package analyzes skin samples of individuals after elective plastic surgery with normal wound healing serving as control group.
WP 2.2: Skin repair with and without hypertrophic scar formation
A classic example of fibroproliferative repair in the skin is hypertrophic scarring classified as a dermal skin lesion, which is raised above skin level, stays within the confines of the initial wound and increases in size by pushing out the margins of the scar without invading the surrounding normal tissue.
Hypertrophic scarring is a condition commonly observed after burns and in regions of prolonged wound healing (>21 days). The underlying pathology of hypertrophic scarring, however, is poorly understood. Hypertrophic scars can be managed conservatively, and only require surgical intervention under special circumstances.
This work package analyzes the clinical and molecular response to a standard treatment regimen in skin regions with and without hypertrophic scars after skin injuries.
WP 2.4: Wound healing in normal and diabetic individuals
Diabetes mellitus is a known factor to cause impaired wound healing. Due to microangiopathic, macroangiopathic and other conditions resulting from atherosclerosis and peripheral neuropathy wound healing in diabetic individuals is usually delayed (hypotrophic, atrophic) and often complicated by immunosuppression and superinfections. The rising prevalence of diabetes mellitus in the elderly population makes it necessary to understand its related processes in relevant clinical wound models.
Split-thickness skin-grafting is a commonly applied technique in plastic surgery, and donor sites of previously uninjured skin regions spontaneously heal within two weeks, representing an ideal condition to monitor clinical and molecular changes in diseased vs. non-diseased states.
This work package analyzes skin repair in donor sites of split-thickness skin grafts in non-diabetic and diabetic individuals.
Study design
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Regular wound healing, young | – | Other: Skin sample, Other: Blood takingRegular skin repair, controlled wound healing conditions in young individuals |
| Regular wound healing, aged | – | Other: Skin sample, Other: Blood takingRegular skin repair, controlled wound healing conditions in aged individuals |
| Hypertrophic scarring, young | – | Other: Skin biopsy, Other: Blood takingSkin repair with and without hypertrophic scarring in young individuals |
| Hypertrophic scarring, aged | – | Other: Skin biopsy, Other: Blood takingSkin repair with and without hypertrophic scarring in aged individuals |
| Non-diabetic, young | – | Other: Skin biopsy, Other: Blood takingSkin repair in non-diabetic young individuals |
| Non-diabetic, aged | – | Other: Skin biopsy, Other: Blood takingSkin repair in non-diabetic aged individuals |
| Diabetic, young | – | Other: Skin biopsy, Other: Blood takingSkin repair in young diabetic individuals |
| Diabetic, aged | – | Other: Skin biopsy, Other: Blood takingSkin repair in aged diabetic individuals |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- WP 2.1 Individuals due for planned elective plastic surgery with regular wound healing WP 2.2 Individuals, who suffered from burns, trauma or having undergone any type of previous surgery with and without hypertrophic scar formation WP 2.4 Individuals, who require split-thickness skin grafting for skin defects with or without diabetes mellitus
Key inclusion criteria (5 listed)
- age 18-45 and 55-85 years, respectively
- age 18-45 and 55-85 years, respectively
- normal and/or hypertrophic scars
- Baux score <100
- age 18-45 and 55-85 years, respectively
Key exclusion criteria (38 listed)
- past medical history of hypertrophic scarring or keloid disease
- cardiac disease adversely affecting peripheral blood flow
- active neoplastic disease
- immunosuppressive condition, congenital or acquired
- anemia
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 |
|---|---|---|
| Skin sampleTaken from regularly discarded tissue during routine operation | Other | Regular wound healing, aged, Regular wound healing, young |
| Skin biopsySkin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90 | Other | Hypertrophic scarring, aged, Hypertrophic scarring, young |
| Skin biopsyBiopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90 | Other | Diabetic, aged, Diabetic, young, Non-diabetic, aged, Non-diabetic, young |
| Blood takingBlood taking on day 0 | Other | Diabetic, aged, Diabetic, young, Hypertrophic scarring, aged, Hypertrophic scarring, young, Non-diabetic, aged, Non-diabetic, young, Regular wound healing, aged, Regular wound healing, young |
| Blood takingBlood taking on day 90 | Other | Diabetic, aged, Diabetic, young, Hypertrophic scarring, aged, Hypertrophic scarring, young, Non-diabetic, aged, Non-diabetic, young |
Primary outcome
Time to wound healing / Scar maturation
Time frame: day14, day90, day180
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 13 Nov 2013.
- Background: PubMed 18347236Gangemi EN, Gregori D, Berchialla P, Zingarelli E, Cairo M, Bollero D, Ganem J, Capocelli R, Cuccuru F, Cassano P, Risso D, Stella M. Epidemiology and risk factors for pathologic scarring after burn wounds. Arch Facial Plast Surg. 2008 Mar-Apr;10(2):93-102. doi: 10.1001/archfaci.10.2.93.
- Background: PubMed 15814118Izadi K, Ganchi P. Chronic wounds. Clin Plast Surg. 2005 Apr;32(2):209-22. doi: 10.1016/j.cps.2004.11.011.
- Background: PubMed 16759300Blakytny R, Jude E. The molecular biology of chronic wounds and delayed healing in diabetes. Diabet Med. 2006 Jun;23(6):594-608. doi: 10.1111/j.1464-5491.2006.01773.x.
- Background: PubMed 15364115Komesu MC, Tanga MB, Buttros KR, Nakao C. Effects of acute diabetes on rat cutaneous wound healing. Pathophysiology. 2004 Oct;11(2):63-67. doi: 10.1016/j.pathophys.2004.02.002.
- Background: PubMed 10513931Niessen FB, Spauwen PH, Schalkwijk J, Kon M. On the nature of hypertrophic scars and keloids: a review. Plast Reconstr Surg. 1999 Oct;104(5):1435-58. doi: 10.1097/00006534-199910000-00031. No abstract available.
- Background: PubMed 2682703Rockwell WB, Cohen IK, Ehrlich HP. Keloids and hypertrophic scars: a comprehensive review. Plast Reconstr Surg. 1989 Nov;84(5):827-37. doi: 10.1097/00006534-198911000-00021. No abstract available.
- Background: PubMed 10810034Gottrup F, Agren MS, Karlsmark T. Models for use in wound healing research: a survey focusing on in vitro and in vivo adult soft tissue. Wound Repair Regen. 2000 Mar-Apr;8(2):83-96. doi: 10.1046/j.1524-475x.2000.00083.x.
- Background: PubMed 12510172Ashcroft GS, Mills SJ, Ashworth JJ. Ageing and wound healing. Biogerontology. 2002;3(6):337-45. doi: 10.1023/a:1021399228395.
- Background: PubMed 14961191Gosain A, DiPietro LA. Aging and wound healing. World J Surg. 2004 Mar;28(3):321-6. doi: 10.1007/s00268-003-7397-6. Epub 2004 Feb 17.
- Background: PubMed 15909438Crooks A. How does ageing affect the wound healing process? J Wound Care. 2005 May;14(5):222-3. doi: 10.12968/jowc.2005.14.5.26777.
- Background: PubMed 6632013Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J. Hypertrophic burn scars: analysis of variables. J Trauma. 1983 Oct;23(10):895-8.
- Background: PubMed 12781605Bombaro KM, Engrav LH, Carrougher GJ, Wiechman SA, Faucher L, Costa BA, Heimbach DM, Rivara FP, Honari S. What is the prevalence of hypertrophic scarring following burns? Burns. 2003 Jun;29(4):299-302. doi: 10.1016/s0305-4179(03)00067-6.
- Ethics Committee of the Medical University of Vienna and the Vienna General HospitalLink provided by the sponsor.
- Working group link (RESOLVE, European Commission Project)Link provided by the sponsor.
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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.
Lars P Kamolz, MD, MSc principal investigator
MUW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age and Cicatrix, Hypertrophic, run by Medical University of Vienna at 1 site in Austria.
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 5 inclusion and 38 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 13 Nov 2013. 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 Austria. 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?
Time to wound healing / Scar maturation (time frame: day14, day90, day180). 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 NCT01040104, which also lists 14 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 13 Nov 2013.