NCT01040104

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

2 years

First QC Date

December 28, 2009

Last Update Submit

November 10, 2013

Conditions

AgeCicatrix, HypertrophicFibrosisDiabetes Mellitus

Keywords

wound healinghypertrophic scarskin transplantationdiabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Time to wound healing / Scar maturation

    day14, day90, day180

Study Arms (8)

Regular wound healing, young

Regular skin repair, controlled wound healing conditions in young individuals

Other: Skin sampleOther: Blood taking

Regular wound healing, aged

Regular skin repair, controlled wound healing conditions in aged individuals

Other: Skin sampleOther: Blood taking

Hypertrophic scarring, young

Skin repair with and without hypertrophic scarring in young individuals

Other: Skin biopsyOther: Blood taking

Hypertrophic scarring, aged

Skin repair with and without hypertrophic scarring in aged individuals

Other: Skin biopsyOther: Blood taking

Non-diabetic, young

Skin repair in non-diabetic young individuals

Other: Skin biopsyOther: Blood taking

Non-diabetic, aged

Skin repair in non-diabetic aged individuals

Other: Skin biopsyOther: Blood taking

Diabetic, young

Skin repair in young diabetic individuals

Other: Skin biopsyOther: Blood taking

Diabetic, aged

Skin repair in aged diabetic individuals

Other: Skin biopsyOther: Blood taking

Interventions

Skin sampleOTHER

Taken from regularly discarded tissue during routine operation

Regular wound healing, agedRegular wound healing, young
Skin biopsyOTHER

Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90

Hypertrophic scarring, agedHypertrophic scarring, young
Blood takingOTHER

Blood taking on day 0

Diabetic, agedDiabetic, youngHypertrophic scarring, agedHypertrophic scarring, youngNon-diabetic, agedNon-diabetic, youngRegular wound healing, agedRegular wound healing, young

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • age 18-45 and 55-85 years, respectively

You may not qualify if:

  • 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
  • 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
  • age 18-45 and 55-85 years, respectively
  • normal and/or hypertrophic scars
  • +27 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (14)

  • 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.

    PMID: 18347236BACKGROUND

  • Izadi K, Ganchi P. Chronic wounds. Clin Plast Surg. 2005 Apr;32(2):209-22. doi: 10.1016/j.cps.2004.11.011.

    PMID: 15814118BACKGROUND

  • Blakytny 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.

    PMID: 16759300BACKGROUND

  • Komesu 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.

    PMID: 15364115BACKGROUND

  • Niessen 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.

    PMID: 10513931BACKGROUND

  • Rockwell 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.

    PMID: 2682703BACKGROUND

  • Gottrup 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.

    PMID: 10810034BACKGROUND

  • Ashcroft GS, Mills SJ, Ashworth JJ. Ageing and wound healing. Biogerontology. 2002;3(6):337-45. doi: 10.1023/a:1021399228395.

    PMID: 12510172BACKGROUND

  • Gosain 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.

    PMID: 14961191BACKGROUND

  • Crooks 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.

    PMID: 15909438BACKGROUND

  • Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J. Hypertrophic burn scars: analysis of variables. J Trauma. 1983 Oct;23(10):895-8.

    PMID: 6632013BACKGROUND

  • Bombaro 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.

    PMID: 12781605BACKGROUND

  • Oliveira 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.

    PMID: 15720096BACKGROUND

  • Mustoe 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.

    PMID: 12142678BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Skin biopsy Blood samples

MeSH Terms

Conditions

Cicatrix, HypertrophicFibrosisDiabetes Mellitus

Condition Hierarchy (Ancestors)

CicatrixPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lars P Kamolz, MD, MSc

    MUW

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 28, 2009

First Posted

December 29, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2011

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

AU(1)