title: Regenerating matrix-based therapy for chronic wound healing: a prospective within-subject pilot study.
abstract: The aim of this study was to determine whether a skin-specific bioengineered regenerating agent (RGTA) heparan sulphate mimetic (CACIPLIQ20) improves chronic wound healing. The design of this article is a prospective within-subject study. The setting was an urban hospital. Patients were 16 African-American individuals (mean age 42 years) with 22 wounds (mean duration 2.5 years) because of either pressure, diabetic, vascular or burn wounds. Two participants each were lost to follow-up or removed because of poor compliance, resulting in 18 wounds analysed. Sterile gauze was soaked with CACIPLIQ20 saline solution, placed on the wound for 5 min, then removed twice weekly for 4 weeks. Wounds were otherwise treated according to the standard of care. Twenty-two percent of wounds fully healed during the treatment period. Wounds showed a 15.2-18.1% decrease in wound size as measured by the vision engineering research group (VERG) digital wound measurement system and total PUSH scores, respectively, at 4 weeks (P = 0.014 and P = 0.003). At 8 weeks there was an 18-26% reduction in wound size (P = 0.04) in the remaining patients. Wound-related pain measured by the visual analogue pain scale and the wound pain scale declined 60% (P = 0.024) and 70% (P = 0.001), respectively. Patient and clinician satisfaction remained positive throughout the treatment period. It is concluded that treatment with CACIPLIQ20 significantly improved wound-related pain and may facilitate wound healing. Patient and clinician satisfaction remained high throughout the trial.
authors.affiliation: SCI Research Center, National Rehabilitation Hospital, Washington, DC 20010, USA. Suzanne.L.Groah@Medstar.net
authors.forename: Suzanne L
authors.initials: SL
authors.lastname: Groah
authors.forename: Alexander
authors.initials: A
authors.lastname: Libin
authors.forename: Miriam
authors.initials: M
authors.lastname: Spungen
authors.forename: Kim-Loan
authors.initials: KL
authors.lastname: Nguyen
authors.forename: Earthaleen
authors.initials: E
authors.lastname: Woods
authors.forename: Marjan
authors.initials: M
authors.lastname: Nabili
authors.forename: Jessica
authors.initials: J
authors.lastname: Ramella-Roman
authors.forename: Denis
authors.initials: D
authors.lastname: Barritault
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001458:Bandages; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D013429:Sulfatases / Q000008:administration & dosage*; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000188:drug therapy*; D014945:Wound Healing / Q000187:drug effects*; D055815:Young Adult
chemical_list: D013429:Sulfatases; C021346:heparan sulfate sulfatase