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Hyaluronic acid dressing (Healoderm) in the treatment of diabetic foot ulcer: A prospective, randomized, placebo-controlled, single-center study

 Moses Lee  ;  Seung Hwan Han  ;  Woo Jin Choi  ;  Kwang Ho Chung  ;  Jin Woo Lee 
 Wound Repair and Regeneration, Vol.24(3) : 581-588, 2016 
Journal Title
 Wound Repair and Regeneration 
Issue Date
Adjuvants, Immunologic/pharmacology ; Adjuvants, Immunologic/therapeutic use* ; Adult ; Bandages ; Diabetic Foot/drug therapy* ; Diabetic Foot/physiopathology ; Female ; Humans ; Hyaluronic Acid/pharmacology ; Hyaluronic Acid/therapeutic use* ; Male ; Middle Aged ; Prospective Studies ; Time Factors ; Treatment Outcome ; Wound Healing/drug effects*
diabetic foot ulcer ; dressing ; hyaluronic acid
Fast and complete healing of a diabetic foot ulcer (DFU) is challenging due to the hostile wound healing environment of the diabetic patients. As a part of a multimodal treatment approach, advanced dressing material using hyaluronic acid (HA) has been found to be effective. However, previous studies have used HA with additional biologics, which interferes in determining the true clinical effect of HA in DFU. To examine the sole effectiveness of HA in DFU treatment, a prospective, randomized, placebo-controlled, single-center study was conducted using an HA dressing without additional substances. Thus, 34 patients who met the inclusion criteria were randomized into two groups (the study group: HA dressing material; the control group: conventional dressing material). During the 12-week study period, complete ulcer healing rate was evaluated as a primary endpoint. Additionally, healing velocity and the mean duration for achieving a 50% ulcer size reduction was compared between the two groups as a secondary endpoint. At the end of the study, the study group presented a significantly higher complete healing rate as compared to that in the control group [84.6% (11/13), 41.6% (5/12), respectively, P = 0.041]. Additionally, faster ulcer healing velocity and shorter mean duration for achieving a 50% ulcer size reduction were observed in the study group (P = 0.022 and 0.004, respectively). The Kaplan-Meier survival analysis for the median time for 50% ulcer healing rate also showed a significantly shorter duration in the study group (21 days vs. 39 days, P = 0.0127). Finally, there were no adverse events related to the dressing materials used in the study. As a major component of the extracellular matrix, this study supports the safety and efficacy of a pure HA dressing without additional substances in treating DFU.
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1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers
Yonsei Authors
이진우(Lee, Jin Woo) ORCID logo https://orcid.org/0000-0002-0293-9017
최우진(Choi, Woo Jin)
한승환(Han, Seung Hwan) ORCID logo https://orcid.org/0000-0002-7975-6067
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