Driver VR, Hanft J, Fylling CP, Beriou JM, Autologel Diabetic Foot Ulcer Study Group., et al.
Ostomy/wound management. Date of publication 2006 Jun 1;volume 52(6):68-70, 72, 74 passim.
1. Ostomy Wound Manage. 2006 Jun;52(6):68-70, 72, 74 passim.
A prospective, randomized, controlled trial of autologous platelet-rich plasma
gel for the treatment of diabetic foot ulcers.
Driver VR(1), Hanft J, Fylling CP, Beriou JM; Autologel Diabetic Foot Ulcer Study
Group.
Author information:
(1)Cytomedix, Inc., 416 Hungerford Drive, Rockville, MD 20850, USA.
Nonhealing diabetic foot ulcers are a common cause of amputation. Emerging
cellular therapies such as platelet-rich plasma gel provide ulcer management
options to avoid loss of limb. The purpose of this prospective, randomized,
controlled, blinded, multicenter clinical study was to evaluate the safety and
efficacy of autologous platelet-rich plasma gel for the treatment of nonhealing
diabetic foot ulcers. One hundred, twenty-nine (129) patients were screened; 72
completed a 7-day screening period and met the study inclusion criteria. Patients
were randomized into two groups - the standard care with platelet-rich plasma gel
or control (saline gel) dressing group - and evaluated biweekly for 12 weeks or
until healing. Healing was confirmed 1 week following closure and monitored for
another 11 weeks. An independent audit led to the exclusion of 32 patients from
the final per-protocol analysis because of protocol violations and failure to
complete treatment. In this group, 13 out of 19 (68.4%) of the platelet-rich
plasma gel and nine out of 21 (42.9%) of the control wounds healed. After
adjusting for wound size outliers (n = 5), significantly more platelet-rich
plasma gel (13 out of 16, 81.3%) than control gel (eight out of 19, 42.1%)
treated wounds healed (P = 0.036, Fisher's exact test). Kaplan-Meier
time-to-healing also was significantly different between groups (log-rank, P =
0.0177). No treatment-related serious adverse events were reported and bovine
thrombin used in the preparation of PRP did not cause Factor V inhibition. When
used with good standards of care, the majority of nonhealing diabetic foot ulcers
treated with autologous platelet-rich plasma gel can be expected to heal.
PMID: 16799184 [Indexed for MEDLINE]
