Chen-Yu Chen1, Re-Wen Wu, Mei-Chi Hsu, Ching-Jung Hsieh, Man-Chun Chou. 1. Chen-Yu Chen, MSN, RN, Hyperbaric Oxygen Therapy Center, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan, R.O.C.; and Chang Gung University, College of Medicine, Taoyuan, Taiwan, R.O.C. Re-Wen Wu, MD, Department of Orthopaedic Surgery, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan, R.O.C.; and Chang Gung University, College of Medicine, Taoyuan, Taiwan, R.O.C. Mei-Chi Hsu, PhD, RN, Department of Nursing, I-Shou University, Kaohsiung City, Taiwan, R.O.C. Ching-Jung Hsieh, MD, Department of Internal Medicine, Paochien Hospital, Ping Tung, Taiwan, R.O.C. Man-Chun Chou, MSN, RN, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan, R.O.C.
Abstract
PURPOSE: The purpose of this study was to compare the effect of standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care alone on wound healing, markers of inflammation, glycemic control, amputation rate, survival rate of tissue, and health-related quality of life in patients with diabetic foot ulcers (DFUs). DESIGN: Prospective, randomized, open-label, controlled study. SUBJECTS AND SETTING: The sample comprised 38 patients with nonhealing DFUs who were deemed poor candidates for vascular surgery. Subjects were randomly allocated to an experimental group (standard care plus HBOT, n = 20) or a control group (standard care alone, n = 18). The study setting was a medical center in Kaohsiung City, Taiwan. METHODS:Hyperbaric oxygen therapy was administered in a hyperbaric chamber under 2.5 absolute atmospheric pressure for 120 minutes; subjects were treated 5 days a week for 4 consecutive weeks. Both groups received standard wound care including debridement of necrotic tissue, topical therapy for Wagner grade 2 DFUs, dietary control and pharmacotherapy to maintain optimal blood glucose levels. Wound physiological indices were measured and blood tests (eg, markers of inflammation) were undertaken. Health-related quality of life was measured using the Medical Outcomes Study 36-Item Short Form. RESULTS:Complete DFU closure was achieved in 5 patients (25%) in the HBOT group (n = 20) versus 1 participant (5.5%) in the routine care group (n = 18) (P = .001). The amputation rate was 5% for the HBOT group and 11% for the routine care group (χ = 15.204, P = .010). The HBOT group showed statistically significant improvements in inflammation index, blood flow, and health-related quality of life from pretreatment to 2 weeks after the last therapy ended (P < .05). Hemoglobin A1c was significantly lower in the HBOT group following treatment (P < .05) but not in the routine care group. CONCLUSIONS:Adjunctive HBOT improved wound healing in persons with DFU. Therapy also reduced the risk of amputation of the affected limb. We assert that at least 20 HBOT sessions are required to be effective.
RCT Entities:
PURPOSE: The purpose of this study was to compare the effect of standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care alone on wound healing, markers of inflammation, glycemic control, amputation rate, survival rate of tissue, and health-related quality of life in patients with diabetic foot ulcers (DFUs). DESIGN: Prospective, randomized, open-label, controlled study. SUBJECTS AND SETTING: The sample comprised 38 patients with nonhealing DFUs who were deemed poor candidates for vascular surgery. Subjects were randomly allocated to an experimental group (standard care plus HBOT, n = 20) or a control group (standard care alone, n = 18). The study setting was a medical center in Kaohsiung City, Taiwan. METHODS: Hyperbaric oxygen therapy was administered in a hyperbaric chamber under 2.5 absolute atmospheric pressure for 120 minutes; subjects were treated 5 days a week for 4 consecutive weeks. Both groups received standard wound care including debridement of necrotic tissue, topical therapy for Wagner grade 2 DFUs, dietary control and pharmacotherapy to maintain optimal blood glucose levels. Wound physiological indices were measured and blood tests (eg, markers of inflammation) were undertaken. Health-related quality of life was measured using the Medical Outcomes Study 36-Item Short Form. RESULTS: Complete DFU closure was achieved in 5 patients (25%) in the HBOT group (n = 20) versus 1 participant (5.5%) in the routine care group (n = 18) (P = .001). The amputation rate was 5% for the HBOT group and 11% for the routine care group (χ = 15.204, P = .010). The HBOT group showed statistically significant improvements in inflammation index, blood flow, and health-related quality of life from pretreatment to 2 weeks after the last therapy ended (P < .05). Hemoglobin A1c was significantly lower in the HBOT group following treatment (P < .05) but not in the routine care group. CONCLUSIONS: Adjunctive HBOT improved wound healing in persons with DFU. Therapy also reduced the risk of amputation of the affected limb. We assert that at least 20 HBOT sessions are required to be effective.
Authors: Rutger C Lalieu; Robin J Brouwer; Dirk T Ubbink; Rigo Hoencamp; René Bol Raap; Rob A van Hulst Journal: Wound Repair Regen Date: 2019-11-26 Impact factor: 3.401