title: Autologous platelet-rich gel for treatment of diabetic chronic refractory cutaneous ulcers: A prospective, randomized clinical trial.
abstract: The purpose of the study is to examine the safety and effectiveness of topical autologous platelet-rich gel (APG) application on facilitating the healing of diabetic chronic refractory cutaneous ulcers. The study was designed as a prospective, randomized controlled trial between January 1, 2007 and December 31, 2011. Eligible inpatients at the Diabetic Foot Care Center of West China Hospital, Sichuan University (China) were randomly prescribed with a 12-week standard treatment of ulcers (the control group) or standard treatment plus topical application APG (the APG group). The wound healing grades (primary endpoint), time to complete healing, and healing velocity within 12 weeks were monitored as short-term effectiveness measurements, while side effects were documented safety endpoints. The rates of survival and recurrence within the follow up were recorded as long-term effectiveness endpoints. Analysis on total diabetic ulcers (DUs) (n = 117) and subgroup analysis on diabetic foot ulcers (DFUs) (n = 103) were both conducted. Standard treatment plus APG treatment was statistically more effective than standard treatment (p < 0.05 in both total DUs and subgroup of DFUs). The subjects defined as healing grade 1 were 50/59 (84.8%) in total DUs and 41/48 (85.4%) in DFUs in the APG group compared with 40/58 (69.0%) and 37/55 (67.3%) in the control group from intent to treat population. The Kaplan-Meier time-to-healing were significantly different between the two groups (p < 0.05 in both total DUs and subgroup of DFUs). No side effects were identified after topical APG application. The long-term survival and recurrence rates were comparative between groups (p > 0.05). This study shows that topical APG application plus standard treatment is safe and quite effective on diabetic chronic refractory cutaneous ulcers, compared with standard treatment.
authors.affiliation: Department of Endocrinology and Metabolism, Diabetic Foot Care Center, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Lan
authors.initials: L
authors.lastname: Li
authors.affiliation: Department of Endocrinology and Metabolism, Diabetic Foot Care Center, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Dawei
authors.initials: D
authors.lastname: Chen
authors.affiliation: Department of Endocrinology and Metabolism, Diabetic Foot Care Center, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Chun
authors.initials: C
authors.lastname: Wang
authors.affiliation: Department of Endocrinology and Metabolism, Diabetic Foot Care Center, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Nanbing
authors.initials: N
authors.lastname: Yuan
authors.affiliation: Department of Endocrinology and Metabolism, Diabetic Foot Care Center, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Department of Endocrinology and Metabolism, Diabetic Foot Care Center, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Liping
authors.initials: L
authors.lastname: He
authors.affiliation: Department of Endocrinology and Metabolism, Diabetic Foot Care Center, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Yanzhi
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Department of Endocrinology and Metabolism, Diabetic Foot Care Center, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Lihong
authors.initials: L
authors.lastname: Chen
authors.affiliation: Chinese Cochrane Centre, Chinese EBM Centre, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Guanjian
authors.initials: G
authors.lastname: Liu
authors.affiliation: Department of Endocrinology and Metabolism, Diabetic Foot Care Center, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Xiujun
authors.initials: X
authors.lastname: Li
authors.affiliation: Department of Endocrinology and Metabolism, Diabetic Foot Care Center, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Xingwu
authors.initials: X
authors.lastname: Ran
mesh_terms: D000287:Administration, Topical; D002681:China / Q000453:epidemiology; D017719:Diabetic Foot / Q000453:epidemiology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D005782:Gels / Q000008:administration & dosage*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D053657:Platelet-Rich Plasma; D011446:Prospective Studies; D012883:Skin Ulcer / Q000453:epidemiology / Q000628:therapy*; D016896:Treatment Outcome; D014945:Wound Healing
chemical_list: D005782:Gels