Hyaluronic Acid for Treatment of Diabetic Foot Ulcers

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Hyaluronic Acid Dressing in the Treatment of Diabetic Foot Ulcer: A Prospective, Randomized, Placebo-Controlled, Single-Center Study

Article specifications

This Prospective, Randomized, Placebo-Controlled, Single-Center Study was published in 2016 in Wound Repair Regeneration Journal (IF 2016: 3.62) by Korean specialists. The purpose of this study is to examine the effectiveness and safety of a new HA dressing material in the treatment of DFU. This study was conducted between September 2012 and January 2014. The inclusion criteria were type 1 or 2 diabetes, a ulcer size ≥ 1.0 cm2 that did not exhibit signs of healing for 6 weeks, Wagner grade 1 or 2, and palpable pulses at the ankle. The assessments of DFU included size, microbial culture study, detailed description of the DFU, and clinical photos. Twenty-five patients were included in the final analysis (study group: 13, control group: 12). Patients in the study group were treated with an HA dressing material (hyaluronic acid 80 ± 5% and poloxamer 10 ± 5%), while patients in the control group were treated with a conventional moisture retentive dressing (petrolatum gauze). Weekly follow-up was conducted with the dressing change up to maximum 12 weeks. 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.

 

Results

The study group presented a significantly higher complete healing rate as compared to that in the control group. Faster ulcer healing velocity and shorter mean duration for achieving a 50% ulcer size reduction were observed in the study group. The Kaplan-Meier analysis for the median time for 50% ulcer healing rate also showed a significantly shorter duration in the study group. There were no adverse events related to the dressing materials. This study supports that a HA dressing without additional substances may offer a safe and effective treatment for DFU.

Tags: Korea Wound Repair and Regeneration Clinical trial 2016

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