NCT03667638

Brief Summary

Chronic soft tissues defects can extend into the fat layer or even deeper and can cause functional disadvantages. Split-thickness skin grafts (STSGs) used to cover these wounds have varying success rates. To improve wound healing in chronic wounds the authors have studied the application of autologous platelet concentrates in a human keratinocyte culture model in vitro and in a combination with surgical procedures in vivo as second line therapy in patients with initially failed wound closure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

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

November 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

September 9, 2018

Last Update Submit

September 11, 2018

Conditions

Keywords

Platelet-Rich PlasmaLaser Doppler ImagingGrowth FactorsWound HealingChronic wound healing disorderWound quality of life

Outcome Measures

Primary Outcomes (1)

  • Wound Closure

    Area of wound closure in % compared to initial size

    4 weeks

Secondary Outcomes (3)

  • Blood Flow

    4 weeks

  • Wound Quality of Life

    21 days

  • Ease of surgical wound closure

    21 days

Study Arms (1)

PRP Intervention

EXPERIMENTAL

PRP injection into wound border

Combination Product: Platelet-Rich Plasma

Interventions

Platelet-Rich PlasmaCOMBINATION_PRODUCT

Adding PRP to wound bed during surgical debridement

Also known as: PRP, PMC
PRP Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • exposed tendons, ligaments or bone for \>3 weeks
  • no healing tendency

You may not qualify if:

  • sepsis
  • intensive care treatment
  • continuous smoking
  • pregnancy or breast feeding women
  • participants of other studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical School Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (39)

  • Danielsen P, Jorgensen B, Karlsmark T, Jorgensen LN, Agren MS. Effect of topical autologous platelet-rich fibrin versus no intervention on epithelialization of donor sites and meshed split-thickness skin autografts: a randomized clinical trial. Plast Reconstr Surg. 2008 Nov;122(5):1431-1440. doi: 10.1097/PRS.0b013e318188202c.

    PMID: 18971727BACKGROUND
  • Gould L, Abadir P, Brem H, Carter M, Conner-Kerr T, Davidson J, DiPietro L, Falanga V, Fife C, Gardner S, Grice E, Harmon J, Hazzard WR, High KP, Houghton P, Jacobson N, Kirsner RS, Kovacs EJ, Margolis D, McFarland Horne F, Reed MJ, Sullivan DH, Thom S, Tomic-Canic M, Walston J, Whitney JA, Williams J, Zieman S, Schmader K. Chronic wound repair and healing in older adults: current status and future research. J Am Geriatr Soc. 2015 Mar;63(3):427-38. doi: 10.1111/jgs.13332. Epub 2015 Mar 6.

    PMID: 25753048BACKGROUND
  • Asadi M, Alamdari DH, Rahimi HR, Aliakbarian M, Jangjoo A, Abdollahi A, Bahar MM, Azadmand A, Forghani N, Sadegh MN, Khayamy ME, Seifalian A. Treatment of life-threatening wounds with a combination of allogenic platelet-rich plasma, fibrin glue and collagen matrix, and a literature review. Exp Ther Med. 2014 Aug;8(2):423-429. doi: 10.3892/etm.2014.1747. Epub 2014 May 29.

    PMID: 25009595BACKGROUND
  • Behm B, Babilas P, Landthaler M, Schreml S. Cytokines, chemokines and growth factors in wound healing. J Eur Acad Dermatol Venereol. 2012 Jul;26(7):812-20. doi: 10.1111/j.1468-3083.2011.04415.x. Epub 2011 Dec 26.

    PMID: 22211801BACKGROUND
  • Alsousou J, Thompson M, Hulley P, Noble A, Willett K. The biology of platelet-rich plasma and its application in trauma and orthopaedic surgery: a review of the literature. J Bone Joint Surg Br. 2009 Aug;91(8):987-96. doi: 10.1302/0301-620X.91B8.22546.

    PMID: 19651823BACKGROUND
  • Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev. 2003 Jul;83(3):835-70. doi: 10.1152/physrev.2003.83.3.835.

    PMID: 12843410BACKGROUND
  • Carter CA, Jolly DG, Worden CE Sr, Hendren DG, Kane CJ. Platelet-rich plasma gel promotes differentiation and regeneration during equine wound healing. Exp Mol Pathol. 2003 Jun;74(3):244-55. doi: 10.1016/s0014-4800(03)00017-0.

    PMID: 12782011BACKGROUND
  • Achora S, Muliira JK, Thanka AN. Strategies to promote healing of split thickness skin grafts: an integrative review. J Wound Ostomy Continence Nurs. 2014 Jul-Aug;41(4):335-9; quiz E1-2. doi: 10.1097/WON.0000000000000035.

    PMID: 24988511BACKGROUND
  • Appel TR, Potzsch B, Muller J, von Lindern JJ, Berge SJ, Reich RH. Comparison of three different preparations of platelet concentrates for growth factor enrichment. Clin Oral Implants Res. 2002 Oct;13(5):522-8. doi: 10.1034/j.1600-0501.2002.130512.x.

    PMID: 12453130BACKGROUND
  • Cohn CS, Lockhart E. Autologous platelet-rich plasma: evidence for clinical use. Curr Opin Hematol. 2015 Nov;22(6):527-32. doi: 10.1097/MOH.0000000000000183.

    PMID: 26390166BACKGROUND
  • Berg L, Meyer S, Ipaktchi R, Vogt PM, Muller A, de Zwaan M. [Psychosocial Distress at Different Time Intervals after Burn Injury]. Psychother Psychosom Med Psychol. 2017 Jun;67(6):231-239. doi: 10.1055/s-0042-111006. Epub 2016 Sep 29. German.

    PMID: 27685256BACKGROUND
  • House SL. Psychological distress and its impact on wound healing: an integrative review. J Wound Ostomy Continence Nurs. 2015 Jan-Feb;42(1):38-41. doi: 10.1097/WON.0000000000000080.

    PMID: 25549307BACKGROUND
  • Blome C, Baade K, Debus ES, Price P, Augustin M. The "Wound-QoL": a short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments. Wound Repair Regen. 2014 Jul-Aug;22(4):504-14. doi: 10.1111/wrr.12193.

    PMID: 24899053BACKGROUND
  • Weibrich G, Kleis WK. Curasan PRP kit vs. PCCS PRP system. Collection efficiency and platelet counts of two different methods for the preparation of platelet-rich plasma. Clin Oral Implants Res. 2002 Aug;13(4):437-43. doi: 10.1034/j.1600-0501.2002.130413.x.

    PMID: 12175382BACKGROUND
  • Weibrich G, Kleis WK, Hafner G, Hitzler WE, Wagner W. Comparison of platelet, leukocyte, and growth factor levels in point-of-care platelet-enriched plasma, prepared using a modified Curasan kit, with preparations received from a local blood bank. Clin Oral Implants Res. 2003 Jun;14(3):357-62. doi: 10.1034/j.1600-0501.2003.00810.x.

    PMID: 12755786BACKGROUND
  • Okuda K, Kawase T, Momose M, Murata M, Saito Y, Suzuki H, Wolff LF, Yoshie H. Platelet-rich plasma contains high levels of platelet-derived growth factor and transforming growth factor-beta and modulates the proliferation of periodontally related cells in vitro. J Periodontol. 2003 Jun;74(6):849-57. doi: 10.1902/jop.2003.74.6.849.

    PMID: 12886996BACKGROUND
  • Kawase T. Platelet-rich plasma and its derivatives as promising bioactive materials for regenerative medicine: basic principles and concepts underlying recent advances. Odontology. 2015 May;103(2):126-35. doi: 10.1007/s10266-015-0209-2. Epub 2015 Jun 4.

    PMID: 26040505BACKGROUND
  • Amable PR, Carias RB, Teixeira MV, da Cruz Pacheco I, Correa do Amaral RJ, Granjeiro JM, Borojevic R. Platelet-rich plasma preparation for regenerative medicine: optimization and quantification of cytokines and growth factors. Stem Cell Res Ther. 2013 Jun 7;4(3):67. doi: 10.1186/scrt218.

    PMID: 23759113BACKGROUND
  • Nurden AT, Nurden P, Sanchez M, Andia I, Anitua E. Platelets and wound healing. Front Biosci. 2008 May 1;13:3532-48. doi: 10.2741/2947.

    PMID: 18508453BACKGROUND
  • Barrientos S, Stojadinovic O, Golinko MS, Brem H, Tomic-Canic M. Growth factors and cytokines in wound healing. Wound Repair Regen. 2008 Sep-Oct;16(5):585-601. doi: 10.1111/j.1524-475X.2008.00410.x.

    PMID: 19128254BACKGROUND
  • Cho JW, Kim SA, Lee KS. Platelet-rich plasma induces increased expression of G1 cell cycle regulators, type I collagen, and matrix metalloproteinase-1 in human skin fibroblasts. Int J Mol Med. 2012 Jan;29(1):32-6. doi: 10.3892/ijmm.2011.803. Epub 2011 Sep 30.

    PMID: 21964487BACKGROUND
  • Carmeliet P, Jain RK. Molecular mechanisms and clinical applications of angiogenesis. Nature. 2011 May 19;473(7347):298-307. doi: 10.1038/nature10144.

    PMID: 21593862BACKGROUND
  • Mammoto T, Jiang A, Jiang E, Mammoto A. Platelet rich plasma extract promotes angiogenesis through the angiopoietin1-Tie2 pathway. Microvasc Res. 2013 Sep;89:15-24. doi: 10.1016/j.mvr.2013.04.008. Epub 2013 May 6.

    PMID: 23660186BACKGROUND
  • Burnouf T, Tseng YH, Kuo YP, Su CY. Solvent/detergent treatment of platelet concentrates enhances the release of growth factors. Transfusion. 2008 Jun;48(6):1090-8. doi: 10.1111/j.1537-2995.2008.01691.x. Epub 2008 Mar 25.

    PMID: 18373502BACKGROUND
  • Shaw TJ, Martin P. Wound repair at a glance. J Cell Sci. 2009 Sep 15;122(Pt 18):3209-13. doi: 10.1242/jcs.031187. No abstract available.

    PMID: 19726630BACKGROUND
  • Eppley BL, Woodell JE, Higgins J. Platelet quantification and growth factor analysis from platelet-rich plasma: implications for wound healing. Plast Reconstr Surg. 2004 Nov;114(6):1502-8. doi: 10.1097/01.prs.0000138251.07040.51.

    PMID: 15509939BACKGROUND
  • Kaltalioglu K, Coskun-Cevher S. A bioactive molecule in a complex wound healing process: platelet-derived growth factor. Int J Dermatol. 2015 Aug;54(8):972-7. doi: 10.1111/ijd.12731. Epub 2014 Oct 14.

    PMID: 25312059BACKGROUND
  • Anitua E, Aguirre JJ, Algorta J, Ayerdi E, Cabezas AI, Orive G, Andia I. Effectiveness of autologous preparation rich in growth factors for the treatment of chronic cutaneous ulcers. J Biomed Mater Res B Appl Biomater. 2008 Feb;84(2):415-21. doi: 10.1002/jbm.b.30886.

    PMID: 17595032BACKGROUND
  • Martinez-Zapata MJ, Marti-Carvajal AJ, Sola I, Exposito JA, Bolibar I, Rodriguez L, Garcia J. Autologous platelet-rich plasma for treating chronic wounds. Cochrane Database Syst Rev. 2012 Oct 17;10:CD006899. doi: 10.1002/14651858.CD006899.pub2.

    PMID: 23076929BACKGROUND
  • Kim SA, Ryu HW, Lee KS, Cho JW. Application of platelet-rich plasma accelerates the wound healing process in acute and chronic ulcers through rapid migration and upregulation of cyclin A and CDK4 in HaCaT cells. Mol Med Rep. 2013 Feb;7(2):476-80. doi: 10.3892/mmr.2012.1230. Epub 2012 Dec 12.

    PMID: 23242428BACKGROUND
  • Reinke JM, Sorg H. Wound repair and regeneration. Eur Surg Res. 2012;49(1):35-43. doi: 10.1159/000339613. Epub 2012 Jul 11.

    PMID: 22797712BACKGROUND
  • Mazzucco L, Borzini P, Gope R. Platelet-derived factors involved in tissue repair-from signal to function. Transfus Med Rev. 2010 Jul;24(3):218-34. doi: 10.1016/j.tmrv.2010.03.004.

    PMID: 20656189BACKGROUND
  • Robson MC, Maggi SP, Smith PD, Wassermann RJ, Mosiello GC, Hill DP, Cooper DM. Original articles: ease of wound closure as an endpoint of treatment efficacy. Wound Repair Regen. 1999 Mar-Apr;7(2):90-6. doi: 10.1046/j.1524-475x.1999.00090.x.

    PMID: 10231510BACKGROUND
  • Limbourg A, Korff T, Napp LC, Schaper W, Drexler H, Limbourg FP. Evaluation of postnatal arteriogenesis and angiogenesis in a mouse model of hind-limb ischemia. Nat Protoc. 2009;4(12):1737-46. doi: 10.1038/nprot.2009.185. Epub 2009 Nov 5.

    PMID: 19893509BACKGROUND
  • Khatib M, Jabir S, Fitzgerald O'Connor E, Philp B. A systematic review of the evolution of laser Doppler techniques in burn depth assessment. Plast Surg Int. 2014;2014:621792. doi: 10.1155/2014/621792. Epub 2014 Aug 7.

    PMID: 25180087BACKGROUND
  • Paul DW, Ghassemi P, Ramella-Roman JC, Prindeze NJ, Moffatt LT, Alkhalil A, Shupp JW. Noninvasive imaging technologies for cutaneous wound assessment: A review. Wound Repair Regen. 2015 Mar-Apr;23(2):149-62. doi: 10.1111/wrr.12262.

    PMID: 25832563BACKGROUND
  • Xian LJ, Chowdhury SR, Bin Saim A, Idrus RB. Concentration-dependent effect of platelet-rich plasma on keratinocyte and fibroblast wound healing. Cytotherapy. 2015 Mar;17(3):293-300. doi: 10.1016/j.jcyt.2014.10.005. Epub 2014 Nov 21.

    PMID: 25456581BACKGROUND
  • Gilliver SC, Ashworth JJ, Ashcroft GS. The hormonal regulation of cutaneous wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):56-62. doi: 10.1016/j.clindermatol.2006.09.012.

    PMID: 17276202BACKGROUND
  • Paulmann A, Strauss S, Limbourg A, Vogt PM. Platelet-derived concentrates influence human keratinocyte proliferation in vitro and induce wound healing in a prospective case series of chronic wounds of different entities in vivo. Innov Surg Sci. 2022 Oct 10;7(2):45-58. doi: 10.1515/iss-2022-0011. eCollection 2022 Jun.

Study Officials

  • Peter Vogt, MD

    Medical School Hannover

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2018

First Posted

September 12, 2018

Study Start

November 1, 2016

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

September 12, 2018

Record last verified: 2018-09

Locations