A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers

Ostomy Wound Management

Volumn 52, Issue 6, 2006, Pages 68-87

  Driver, Vickie R ^b   Hanft, Jason ^b   Fylling, Carelyn P ^a   Beriou, Judy M ^b  

^a Cytomedix Inc   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

GLYCOSYLATED HEMOGLOBIN;

ADULT; ARTICLE; AUTOTRANSPLANTATION; BLOOD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETIC FOOT; DOUBLE BLIND PROCEDURE; FEMALE; FOOD AND DRUG ADMINISTRATION; GEL; HUMAN; INTRADERMAL DRUG ADMINISTRATION; MALE; METABOLISM; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY; PATIENT SELECTION; PLASMA; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTE; TIME; TREATMENT OUTCOME; UNITED STATES; WOUND HEALING;

ADMINISTRATION, CUTANEOUS; ADULT; BLOOD PLATELETS; DIABETIC FOOT; DOUBLE-BLIND METHOD; FEMALE; GELS; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; MALE; MIDDLE AGED; PATIENT SELECTION; PLASMA; PROSPECTIVE STUDIES; RESEARCH DESIGN; TIME FACTORS; TRANSPLANTATION, AUTOLOGOUS; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WOUND HEALING;

EID: 33747621370     PISSN: 08895899     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (44)

1. Centers for Disease Control and Prevention. National diabetes fact sheet: general information and national estimates on diabetes in the United States. Atlanta, Ga: United States Department of Health and Human Services. Center for Disease Control and Prevention; 2005.
2. American Diabetes Association. Consensus development conference on diabetic foot wound care. Diabetes Care. 1999; 22 (8): 1354-1360.
3. Mani R, Falanga V, Shearman CP, Sandeman D. Chronic Wound Healing: Clinical Measurement and Basic Science. New York, NY: WB Saunders; 1999 : 17-23.
4. Pecoraro RE, Reiber GE, Burgess EM. Pathways to diabetic limb amputation. Basis for prevention. Diabetes Care. 1990; 13 (5) : 513-521.
5. American Diabetes Association. Available at: www.diabetes.org. Accessed January 25, 2006.
6. Frykberg RG, Armstrong DG, Giurini J, et al. Diabetic Foot Disorders: A Clinical Practice Guideline. Park Ridge, III: American College of Foot and Ankle Surgeons; 2000.
7. Holloway GA, Steed DL, DeMarco JM, et al. A randomized controlled dose response trial of activated platelet supernatant, topical CT-102 in chronic, nonhealing, diabetic wounds. WOUNDS. 1993; 5 : 160-168.
8. Steed DL, Gloslen JB, Holloway GA, et al. CT-102 activated platelet supernatant topical: a randomized, prospective, double blind trial in healing of chronic diabetic foot ulcers. Diabetes Care. 1992; 15 : 1598-1604.
9. Atri SC, Mistr J, Bisht D, et al. Use of homologous platelet factors in achieving total healing of recalcitrant skin ulcers. Surgery. 1990; 108 : 508-512.
10. Knighton DR, Ciresi K, Regel VD, et al. Stimulation of repair in chronic nonhealing cutaneous ulcers: a prospectively randomized blinded trial using platelet-derived wound healing formula. Surg Gynecol Obstet. 1990; 170 : 56-60.
11. Fylling CP, Baxter CR, Ben nett KG, et al. Multicenter clinical review: using autologous platelet gel for the treatment of diabetic plantar wounds. Diabetes. 2001; 50 (suppl 2) : 229A.
12. Glover JL, Weingarten MS, Buchbinder DS, et al. A four-year multicenter retrospective study of topical multiple growth factor therapy for chronic wounds. Adv Wound Care. 1997; 10 (1) : 27-32.
13. Keyser JE. Diabetic wound healing and limb salvage in an outpatient wound care program. South Med J. 1993; 86 : 311-317.
14. Fylling CP. A five center study of diabetic wound healing in comprehensive wound management programs. Diabetes. 1992; 41(suppl A) : 82A.
15. Knighton DR, Fylling CP, Regel VD, et al. Amputation prevention in an independently reviewed atrisk diabetic population using a comprehensive wound care protocol. Amer J Surg. 1990; 160 : 466-472.
16. Fylling CP, Knighton DR, Gordinier RH. The use of a comprehensive wound care protocol including topical growth factor therapy in treatment of diabetic neuropathic ulcers. In: Ward J, Goto Y. Diabetic Neuropathy. New York, NY: John Wiley & Sons; 1990 : 567-578.
17. Doucette MM, Fylling CP, Knighton DR. Amputation prevention in a high-risk population through a comprehensive wound healing protocol. Arch Phys Med Rehabil. 1989; 70 : 780-785.
18. Knighton DR, Fylling CP, Doucette MM. Wound healing and amputation in a high-risk diabetic population. WOUNDS. 1989; 2 : 107-114.
19. Knighton DR, Ciresi KF, Regel VD, et al. Classification and treatment of chronic nonhealing wounds: successful treatment with autologous platelet-derived wound healing factors (PDWHF). Ann Surg. 1986; 3 : 322-330.
20. Bentkover JF, Champion AH. Economic evaluation of alternative methods of treatment for diabetic foot ulcer patients: cost effectiveness of platelet releasate and wound care clinics. WOUNDS. 1993; 5 : 207-215.
21. Fylling CP, McKeown PC. Cost and healing efficacy of treating diabetic foot ulcers in a comprehensive wound management program with growth factor therapy. Diabetes. 1990; 39(suppl A) : 18A.
22. Bennett NT, Schultz GS. Growth factors and wound healing. Part II. Role in chronic wound healing. Am J Surg. 1993; 166(1) : 74-81.
23. Mosesson MW. Fibrinogen and fibrin structure and functions. J Thromb Haemost. 2005; 3 (8): 1894-1904.
24. Margolis DJ, Kantor J, Santana J, et al. Effectiveness of platelet releasate for the treatment of diabetic neuropathic foot ulcers. Diabetes Care. 2001; 24 : 483-488.
25. Lipsky BA, Berendt AR, Desery H. Diagnosis and treatment of diabetic foot infections. Guidelines for Diabetic Foot Infections. Clin Infect Dis. 2004 : 39 : 895-910.
26. Armstrong DG, Lavery LA, Harkless LB. Validation of a diabetic classification system; the contribution of depth, infection, and ischemia to risk of amputation. Diabetes Care. 1998; 21(5) : 855-859.
27. Cooper DM. Assessment, measurement, and evaluation: their pivotal roles in wound healing. In: Bryant RA. Acute and Chronic Wounds. St. Louis, Mo: Mosby;2000 : 61.
28. Fylling CP, Baxter CR, Ben nett KG, et al. Multicenter clinical review: using autologous platelet gel for the treatment of diabetic plantar wounds. Poster and oral presentation at the American Diabetes Association Annual Meeting and Scientific Sessions. Philadelphia, Pa. June 22-26, 2001.
29. Beriou J, Fylling CP, Justice P. A retrospective review of healing progress of 102 chronic wounds during the first 28 days of treatment with autologous platelet rich plasma gel. Poster presentation at: the Symposium on Advanced Wound Care and Medical Research Forum. Orlando, Fla. May 5- 7, 2004.
30. Margolis DJ, Kantor J, Berlin J. Healing of diabetic neuropathic foot ulcers receiving standard treatment. Diabetes Care. 1999; 22 : 692-695.
31. Lee ET. Statistical Methods for Survival Data Analysis. Belmont, Calif: Lifetime Learning Publications, Wadsworth, lnc; 1980.
32. Kalbfleisch JD, Prentice RL. The Statistical Analysis of Failure Time Data. New York, NY: John Wiley and Sons; 1980.
33. Margolis DJ, Gelfand JM, Hoffstad O, Berlin J. Surrogate endpoints for the treatment of diabetic neuropathic foot ulcers. Diabetes Care. 2003; 26 : 1696-1700.
34. Veves A, Falanga V, Armstrong DG, et al. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers. Diabetes Care. 2001; 24(2) : 290-295.
35. Lipkin S, Chaikof E, Isseroff Z, et al. Effectiveness of bilayered cellular matrix in healing of neuropathic diabetic foot ulcers: Results of a multicenter pilot trial. WOUNDS. 2003; 15(7) : 230-236.
36. Steed DL Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity diabetic ulcers. J Vase Surg. 1995; 21 : 71-81.
37. 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 ulcers. Diabetes Care. 1998; 21(5) : 822-827.
38. Bradley M, Cullum N, Nelson EA, et al. Systematic reviews of wound care management: dressings and topical agents used in the healing of chronic wounds. Health Technol Assess. 1999; 3(17 Part 2).
39. Winterbottom N, Kuo JM, Nguyen K, et al. Antigenic responses to bovine thrombin exposure during surgery: a prospective study of 309 patients. J Applied Res Clin Exper Therapeutics. 2002; 2(1) : 20-29.
40. Jeffcoate WJ, Price P, Harding KG, et al. Wound healing and treatments for people with diabetic foot ulcers. Diabetes Metab Res Rev. 2004; 20(suppl 1) : S78-S89.
41. Marston WA, Dermagraft Diabetic Foot Ulcer Study Group. Risk factors associated with healing chronic diabetic foot ulcers: the importance of hyperglycemia. Ostomy Wound Manage. 2006; 52 (3) : 26-28, 30, 32.
42. Kassolis, JD, Reynolds, Ma. Evaluation of the adjunctive benefits of platelet-rich plasma in subantral sinus augmentation. J Craniofacial Surg. 2005; 16(2) : 280-287.
43. Grageda E. Platelet-rich plasma and bone graft materials: a review and a standardized research protocol. Implant Dent. 2004; 13(4) : 301-309.
44. Weibrich G, Hansen T, Kleis W, et al. Effect of platelet concentration in platelet-rich plasma on periimplant bone regeneration. Bone. 2004; 34(4) : 665-671.