drugset / Trial / NCT02802995
Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is to * To evaluate the safety and tolerability of Platelet Rich plasma(PRP)/Thrombin mixture in treating chronic venous ulcers * To evaluate efficacy of PRP/Thrombin mixture in treating chronic venous ulcers
Timeline
- Start
- 2016-05
- Primary completion
- 2017-05
- Completion
- 2017-05
Publications
- Background Callam MJ, Ruckley CV, Harper DR, Dale JJ. Chronic ulceration of the leg: extent of the problem and provision of care. Br Med J (Clin Res Ed). 1985 Jun 22;290(6485):1855-6. doi: 10.1136/bmj.290.6485.1855.
- Background Dolynchuk K, Keast D, Campbell K, Houghton P, Orsted H, Sibbald G, Atkinson A. Best practices for the prevention and treatment of pressure ulcers. Ostomy Wound Manage. 2000 Nov;46(11):38-52; quiz 53-4.
- Background Franz RC. Platelet concentrate-thrombin coagulum: a new biological dressing for the promotion of wound healing. S Afr Med J. 1987 Dec 5;72(11):810-1. No abstract available.
- Background Franz RW, Shah KJ, Halaharvi D, Franz ET, Hartman JF, Wright ML. A 5-year review of management of lower extremity arterial injuries at an urban level I trauma center. J Vasc Surg. 2011 Jun;53(6):1604-10. doi: 10.1016/j.jvs.2011.01.052. Epub 2011 Apr 8.
- Background Hammermeister KE, Johnson R, Marshall G, Grover FL. Continuous assessment and improvement in quality of care. A model from the Department of Veterans Affairs Cardiac Surgery. Ann Surg. 1994 Mar;219(3):281-90. doi: 10.1097/00000658-199403000-00008.
- Background Hess CT. Pressure ulcer evidence-based treatment pathway integrated with evidence-based decisions: part 3. Adv Skin Wound Care. 2013 Sep;26(9):432. doi: 10.1097/01.ASW.0000434207.28117.5d. No abstract available.
- Background Phillips LG, Mann R, Heggers JP, Linares HA, Robson MC. In vivo ovine flap model to evaluate surgical infection and tissue necrosis. J Surg Res. 1994 Jan;56(1):1-4. doi: 10.1006/jsre.1994.1001.
- Background Pierce GF, Mustoe TA, Altrock BW, Deuel TF, Thomason A. Role of platelet-derived growth factor in wound healing. J Cell Biochem. 1991 Apr;45(4):319-26. doi: 10.1002/jcb.240450403.
- Background Pierce GF, Brown D, Mustoe TA. Quantitative analysis of inflammatory cell influx, procollagen type I synthesis, and collagen cross-linking in incisional wounds: influence of PDGF-BB and TGF-beta 1 therapy. J Lab Clin Med. 1991 May;117(5):373-82.
- Background Roe DF, Gibbins BL, Ladizinsky DA. Topical dissolved oxygen penetrates skin: model and method. J Surg Res. 2010 Mar;159(1):e29-36. doi: 10.1016/j.jss.2009.10.039. Epub 2009 Nov 21.
- Background Steed DL, Ricotta JJ, Prendergast JJ, Kaplan RJ, Webster MW, McGill JB, Schwartz SL. Promotion and acceleration of diabetic ulcer healing by arginine-glycine-aspartic acid (RGD) peptide matrix. RGD Study Group. Diabetes Care. 1995 Jan;18(1):39-46. doi: 10.2337/diacare.18.1.39.
- Background Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care. 1998 May;21(5):822-7. doi: 10.2337/diacare.21.5.822.
- Background Wilkins RG, Unverdorben M. Wound cleaning and wound healing: a concise review. Adv Skin Wound Care. 2013 Apr;26(4):160-3. doi: 10.1097/01.ASW.0000428861.26671.41.
- Results Atri SC, Misra J, Bisht D, Misra K. Use of homologous platelet factors in achieving total healing of recalcitrant skin ulcers. Surgery. 1990 Sep;108(3):508-12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Platelet Rich Plasma | Other / unclassified | — | Topical |
| Subject | thrombin | Protein / enzyme biologic | — | Topical |