Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT01040104
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2009-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Skin biopsy Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'lastUpdateSubmitDate': '2013-11-10', 'studyFirstSubmitDate': '2009-12-28', 'studyFirstSubmitQcDate': '2009-12-28', 'lastUpdatePostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to wound healing / Scar maturation', 'timeFrame': 'day14, day90, day180'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['wound healing', 'hypertrophic scar', 'skin transplantation', 'diabetes mellitus'], 'conditions': ['Age', 'Cicatrix, Hypertrophic', 'Fibrosis', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '18347236', 'type': 'BACKGROUND', 'citation': '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': '15814118', 'type': 'BACKGROUND', 'citation': 'Izadi K, Ganchi P. Chronic wounds. Clin Plast Surg. 2005 Apr;32(2):209-22. doi: 10.1016/j.cps.2004.11.011.'}, {'pmid': '16759300', 'type': 'BACKGROUND', 'citation': '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': '15364115', 'type': 'BACKGROUND', 'citation': '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': '10513931', 'type': 'BACKGROUND', 'citation': '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': '2682703', 'type': 'BACKGROUND', 'citation': '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': '10810034', 'type': 'BACKGROUND', 'citation': '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': '12510172', 'type': 'BACKGROUND', 'citation': 'Ashcroft GS, Mills SJ, Ashworth JJ. Ageing and wound healing. Biogerontology. 2002;3(6):337-45. doi: 10.1023/a:1021399228395.'}, {'pmid': '14961191', 'type': 'BACKGROUND', 'citation': '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': '15909438', 'type': 'BACKGROUND', 'citation': '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': '6632013', 'type': 'BACKGROUND', 'citation': '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': '12781605', 'type': 'BACKGROUND', 'citation': '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': '15720096', 'type': 'BACKGROUND', 'citation': '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': '12142678', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.meduniwien.ac.at/ethik/index.htm', 'label': 'Ethics Committee of the Medical University of Vienna and the Vienna General Hospital'}]}, 'descriptionModule': {'briefSummary': 'Regular wound healing follows a well-ordered sequence of overlapping phases: inflammation, proliferation, maturation and remodelling.\n\nIn 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.\n\nOrgan 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.\n\nRESOLVE\'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.\n\nThe structured approach is based on\n\n* different forms of wound healing,\n* different human diseases and\n* different genetic backgrounds,\n\naiming to provide future diagnostic tools in various organs, to create transgenic animal test systems, and to identify molecular targets involved in fibroproliferative wound healing.', 'detailedDescription': '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).\n\nWP 2.1: Regular skin repair\n\nIn 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.\n\nWP 2.2: Skin repair with and without hypertrophic scar formation\n\nA 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.\n\nHypertrophic 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.\n\nThis work package analyzes the clinical and molecular response to a standard treatment regimen in skin regions with and without hypertrophic scars after skin injuries.\n\nWP 2.4: Wound healing in normal and diabetic individuals\n\nDiabetes 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.\n\nSplit-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.\n\nThis work package analyzes skin repair in donor sites of split-thickness skin grafts in non-diabetic and diabetic individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'WP 2.1 Individuals due for planned elective plastic surgery with regular wound healing\n\nWP 2.2 Individuals, who suffered from burns, trauma or having undergone any type of previous surgery with and without hypertrophic scar formation\n\nWP 2.4 Individuals, who require split-thickness skin grafting for skin defects with or without diabetes mellitus', 'healthyVolunteers': True, 'eligibilityCriteria': 'WP2.1\n\nInclusion Criteria:\n\n* age 18-45 and 55-85 years, respectively\n\nExclusion Criteria:\n\n* past medical history of hypertrophic scarring or keloid disease\n* cardiac disease adversely affecting peripheral blood flow\n* active neoplastic disease\n* immunosuppressive condition, congenital or acquired\n* anemia\n* autoimmune disorder\n* acute or chronic renal failure\n* liver cirrhosis or active hepatitis\n* active substance-abuse disorder\n* severe underweight (body mass index \\<16)\n* endocrinological disorder\n* pregnancy or lactation for women of child-bearing age\n\nWP2.2\n\nInclusion Criteria:\n\n* age 18-45 and 55-85 years, respectively\n* normal and/or hypertrophic scars\n* Baux score \\<100\n\nExclusion Criteria:\n\n* sepsis\n* electrical and/or chemical burn\n* clinically significant wound infection in areas of planned biopsies\n* cardiac disease adversely affecting peripheral blood flow\n* active neoplastic disease\n* immunosuppressive condition, congenital or acquired\n* autoimmune disorder\n* acute or chronic renal failure\n* liver cirrhosis or active hepatitis\n* active substance-abuse disorder\n* severe underweight (body mass index \\<16)\n* endocrinological disorder\n* pregnancy or lactation for women of child-bearing age\n\nWP 2.4\n\nInclusion Criteria:\n\n* age 18-45 and 55-85 years, respectively\n\nExclusion Criteria:\n\n* cardiac disease adversely affecting peripheral blood flow\n* active neoplastic disease\n* immunosuppressive condition, congenital or acquired\n* anemia\n* autoimmune disorder\n* acute or chronic renal failure\n* liver cirrhosis or active hepatitis\n* substance-abuse disorder\n* severe underweight (body mass index \\<16)\n* thyroid function disorder\n* pregnancy or lactation for women of child-bearing age'}, 'identificationModule': {'nctId': 'NCT01040104', 'acronym': 'RESOLVE', 'briefTitle': 'Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Pilot Study of Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals', 'orgStudyIdInfo': {'id': 'FP7-202047.WP.2.1-2.2-2.4'}, 'secondaryIdInfos': [{'id': 'MUW-EK-Nr_015/2009', 'type': 'OTHER', 'domain': 'MUVienna'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Regular wound healing, young', 'description': 'Regular skin repair, controlled wound healing conditions in young individuals', 'interventionNames': ['Other: Skin sample', 'Other: Blood taking']}, {'label': 'Regular wound healing, aged', 'description': 'Regular skin repair, controlled wound healing conditions in aged individuals', 'interventionNames': ['Other: Skin sample', 'Other: Blood taking']}, {'label': 'Hypertrophic scarring, young', 'description': 'Skin repair with and without hypertrophic scarring in young individuals', 'interventionNames': ['Other: Skin biopsy', 'Other: Blood taking']}, {'label': 'Hypertrophic scarring, aged', 'description': 'Skin repair with and without hypertrophic scarring in aged individuals', 'interventionNames': ['Other: Skin biopsy', 'Other: Blood taking']}, {'label': 'Non-diabetic, young', 'description': 'Skin repair in non-diabetic young individuals', 'interventionNames': ['Other: Skin biopsy', 'Other: Blood taking']}, {'label': 'Non-diabetic, aged', 'description': 'Skin repair in non-diabetic aged individuals', 'interventionNames': ['Other: Skin biopsy', 'Other: Blood taking']}, {'label': 'Diabetic, young', 'description': 'Skin repair in young diabetic individuals', 'interventionNames': ['Other: Skin biopsy', 'Other: Blood taking']}, {'label': 'Diabetic, aged', 'description': 'Skin repair in aged diabetic individuals', 'interventionNames': ['Other: Skin biopsy', 'Other: Blood taking']}], 'interventions': [{'name': 'Skin sample', 'type': 'OTHER', 'description': 'Taken from regularly discarded tissue during routine operation', 'armGroupLabels': ['Regular wound healing, aged', 'Regular wound healing, young']}, {'name': 'Skin biopsy', 'type': 'OTHER', 'description': 'Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90', 'armGroupLabels': ['Hypertrophic scarring, aged', 'Hypertrophic scarring, young']}, {'name': 'Skin biopsy', 'type': 'OTHER', 'description': 'Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90', 'armGroupLabels': ['Diabetic, aged', 'Diabetic, young', 'Non-diabetic, aged', 'Non-diabetic, young']}, {'name': 'Blood taking', 'type': 'OTHER', 'description': 'Blood taking on day 0', 'armGroupLabels': ['Diabetic, aged', 'Diabetic, young', 'Hypertrophic scarring, aged', 'Hypertrophic scarring, young', 'Non-diabetic, aged', 'Non-diabetic, young', 'Regular wound healing, aged', 'Regular wound healing, young']}, {'name': 'Blood taking', 'type': 'OTHER', 'description': 'Blood taking on day 90', 'armGroupLabels': ['Diabetic, aged', 'Diabetic, young', 'Hypertrophic scarring, aged', 'Hypertrophic scarring, young', 'Non-diabetic, aged', 'Non-diabetic, young']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Lars P Kamolz, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MUW'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Union', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'David Lumenta, MD', 'investigatorAffiliation': 'Medical University of Vienna'}}}}