PMID- 29718812
OWN - NLM
STAT- MEDLINE
DCOM- 20190211
LR  - 20190215
IS  - 1943-2704 (Electronic)
IS  - 1044-7946 (Linking)
VI  - 30
IP  - 7
DP  - 2018 Jul
TI  - Safety and Efficacy of an Autologous Blood Clot Product in the Management of 
      Texas 1A or 2A Neuropathic Diabetic Foot Ulcers: A Prospective, Multicenter, Open 
      Label Pilot Study.
PG  - 84-89
LID - WNDS20180420-3 [pii]
AB  - OBJECTIVE: This pilot study evaluates safety in terms of the occurrence of 
      adverse events (AEs) as well as the efficacy in terms of complete wound healing 
      rates of a blood clot product when applied to chronic neuropathic diabetic foot 
      ulcers (DFUs). MATERIALS AND METHODS: Participants were chosen from patients with 
      DFUs visiting the wound care clinic. Up to 10 mL of blood drawn from each 
      participant was injected into the product's clotting tray. Within 12 minutes, the 
      blood clot product was formed, applied to the single DFU of each participant, and 
      covered with primary and secondary dressings. Patients received up to 12 blood 
      clot product applications every 5 to 9 days for up to 12 weeks. RESULTS: Twenty 
      patients were enrolled; 20 were analyzed in the intent-to-treat (ITT) population 
      and 18 were in the per-protocol (PP) population. Thirty-two AEs occurred (only 2 
      were possibly device related). The mean AE rate for both the ITT and PP 
      populations was 1.6. The proportion of wounds healed in the ITT and PP 
      populations was 13 out of 20 (65%) and 13 out of 18 (72.2%), respectively. 
      Percentage area reduction (PAR) for the ITT population at 4 and 12 weeks was 
      61.6% and 67.1%, respectively; the PARs for the PP population were 60.3% and 
      76.2% at 4 and 12 weeks, respectively. Mean times to wound healing were 59 days 
      and 56 days in the ITT and PP populations, respectively. CONCLUSIONS: This study 
      demonstrates that the blood clot product is safe and efficacious for treating 
      DFUs.
FAU - Snyder, Robert J
AU  - Snyder RJ
FAU - Kasper, Maria A
AU  - Kasper MA
FAU - Patel, Keyur
AU  - Patel K
FAU - Carter, Marissa J
AU  - Carter MJ
FAU - Kushnir, Igal
AU  - Kushnir I
FAU - Kushnir, Alon
AU  - Kushnir A
FAU - Serena, Thomas E
AU  - Serena TE
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20180420
PL  - United States
TA  - Wounds
JT  - Wounds : a compendium of clinical research and practice
JID - 9010276
SB  - IM
MH  - Aged
MH  - Bandages
MH  - *Biological Dressings
MH  - Debridement/*methods
MH  - Diabetic Foot/complications/*pathology/*therapy
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Prospective Studies
MH  - *Thrombosis
MH  - Treatment Outcome
MH  - Wound Healing/*physiology
EDAT- 2018/05/03 06:00
MHDA- 2019/02/12 06:00
CRDT- 2018/05/03 06:00
PHST- 2018/05/03 06:00 [pubmed]
PHST- 2019/02/12 06:00 [medline]
PHST- 2018/05/03 06:00 [entrez]
AID - WNDS20180420-3 [pii]
PST - ppublish
SO  - Wounds. 2018 Jul;30(7):84-89. Epub 2018 Apr 20.