Sung Ho Steve Bae, Windy Cole, Imaze M Davis, Dmitry Sandler, J David Warren, Janet S Mackenzie
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引用次数: 0
Abstract
Objective: Diabetic foot wounds pose many challenges during the healing process and often become hard-to-heal (chronic) wounds. This study compared a novel botanical hydrogel with a widely used hydrogel to determine both its non-inferiority and impact on the progress of diabetic foot wounds.
Method: The study was a prospective, double-blinded, randomised controlled study comparing healing outcomes. There were two cohorts: one treated with LAVIOR Diabetic Wound Gel (LDWG; Lavior Pharma Inc., US), which contains botanical extracts, and the other treated with SoloSite Wound Gel (SSWG) (Smith+Nephew Inc., US). The wounds were treated and evaluated weekly over a six-week period. Subjective patient data were collected with the Diabetic Foot Scale (DFS) at each visit.
Results: The study cohort comprised 65 patients: 34 patients treated with LDWG, and 31 patients treated with SSWG. The patients treated with LDWG demonstrated at least as much progress in healing as those treated with SSWG. There was a greater reduction in wound surface area in the LDWG group from baseline to the end of the study (7.32cm2 to 2.24cm2) than in the SSWG group (8.18cm2 to 5.16cm2) (p=0.127). Reduction in pain was significantly improved in wounds treated with LDWG compared with SSWG (during follow-up weeks 1-4; p<0.001; week 5 was not statistically significant). The LDWG group demonstrated significantly greater improvement in DFS scores by the end of the study (scores of 192 versus 219, respectively, compared with the SSWG group; p=0.001). Wound closure times were comparable between the two groups.
Conclusion: In this study, LDWG demonstrated non-inferiority to SSWG; better results were observed in pain reduction and surface area reduction. Further study is indicated.
期刊介绍:
Journal of Wound Care (JWC) is the definitive wound-care journal and the leading source of up-to-date research and clinical information on everything related to tissue viability. The journal was first launched in 1992 and aimed at catering to the needs of the multidisciplinary team. Published monthly, the journal’s international audience includes nurses, doctors and researchers specialising in wound management and tissue viability, as well as generalists wishing to enhance their practice.
In addition to cutting edge and state-of-the-art research and practice articles, JWC also covers topics related to wound-care management, education and novel therapies, as well as JWC cases supplements, a supplement dedicated solely to case reports and case series in wound care. All articles are rigorously peer-reviewed by a panel of international experts, comprised of clinicians, nurses and researchers.
Specifically, JWC publishes:
High quality evidence on all aspects of wound care, including leg ulcers, pressure ulcers, the diabetic foot, burns, surgical wounds, wound infection and more
The latest developments and innovations in wound care through both preclinical and preliminary clinical trials of potential new treatments worldwide
In-depth prospective studies of new treatment applications, as well as high-level research evidence on existing treatments
Clinical case studies providing information on how to deal with complex wounds
Comprehensive literature reviews on current concepts and practice, including cost-effectiveness
Updates on the activities of wound care societies around the world.