title: A retrospective, longitudinal study to evaluate healing lower extremity wounds in patients with diabetes mellitus and ischemia using standard protocols of care and platelet-rich plasma gel in a Japanese wound care program﻿.
abstract: Chronic wounds, especially in patients with diabetes mellitus (DM), are a major health challenge in Japan. The goal of wound care centers (WCCs) in Japan is to facilitate healing and prevent lower extremity amputations (LEAs) using standardized protocols of patient and wound care. The standard treatment algorithm includes a complete patient and wound assessment, history, physical exam, and a variety of diagnostic tests that determine the need for infection control intervention, revascularization, excision and debridement, growth factor/platelet rich plasma (PRP) gel therapy, skin graft/ flap, wound protection, and education. All patient and wound data are entered in a secure central database for all WCCs. To evaluate the outcomes of standard care regimens compared to the use of a topical PRP gel treatment in patients with a variety of complex wounds, a retrospective, longitudinal study was conducted. Wound outcomes from 39 patients with 40 chronic, nonhealing, lower extremity wounds were evaluated between two time periods: between first presentation at the WCC (T1) and after using standard topical treatments (T2) and between T2 and after using the PRP gel treatment (T3). Patient average age was 66.8 years (SD: 10.60) and mean wound duration was 99.7 days before treatment (SD: 107.73); and the majority of patients (85%) had DM. Wounds were classified as ischemic diabetic (n = 24), diabetic (n = 10), ischemic (n = 5), and pressure ulcer (n = 1). DFUs were Wagner III (77%) and lV (23%). Of those, 60% were in patients with arteriosclerotic obliterans (ASO). Infection (abscess, cellulitis, osteomyelitis, and/or gangrene) was present in all wounds and treated using debridement, antibiotic therapy, and surgery as deemed appropriate. During the first treatment period (T1 to T2) of 75.3 days, which included revascularization and/or debridement along with standard of care, none of the wounds healed and the average wound area, depth, and volume increased. Following topical PRP gel treatment, 83% of wounds healed within 145.2 days (T2 to T3) (P = 0.00002). Only one patient required an LEA. The results of this study suggest that good healing outcomes and a low amputation rate can be obtained with a protocol of supportive care (including revascularization procedures) and the PRP gel treatment. Prospective controlled studies comparing the use of this PRP gel to other advanced treatments are warranted.
authors.affiliation: Wound Care Center, Hokkaido Cardiovascular Hospital, Sapporo-shi, Hokkaido, Japan.﻿
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakata
authors.forename: Shigeru
authors.initials: S
authors.lastname: Sasaki
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Handa
authors.forename: Takashi
authors.initials: T
authors.lastname: Uchino
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Sasaki
authors.forename: Ryuji
authors.initials: R
authors.lastname: Higashita
authors.forename: Norio
authors.initials: N
authors.lastname: Tsuno
authors.forename: Toru
authors.initials: T
authors.lastname: Hiyoshi
authors.forename: Shuhei
authors.initials: S
authors.lastname: Morimoto
authors.forename: Chugo
authors.initials: C
authors.lastname: Rinoie
authors.forename: Natsuko
authors.initials: N
authors.lastname: Saito
mesh_terms: D000368:Aged; D002985:Clinical Protocols; D048909:Diabetes Complications / Q000628:therapy*; D005260:Female; D005782:Gels; D006801:Humans; D007511:Ischemia / Q000628:therapy*; D007564:Japan; D007866:Leg / Q000098:blood supply*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D053657:Platelet-Rich Plasma; D012189:Retrospective Studies; D014945:Wound Healing
chemical_list: D005782:Gels