Study Protocol for a Randomised Controlled Trial to Investigate the Enhancement of Diabetic Foot Ulcer Healing Using Low-Magnitude High-Frequency Vibration Treatment
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摘要Background: Diabetes has a prevalence of 11.6% in China with diabetic foot ulcerations affecting over 30 million Chinese. 85% of these patients require amputation and 5-year mortality for diabetics is 70% when associated foot ulcers. Clinical trials have shown that standing on whole-body vibration platforms, specifically low-magnitude high-frequency vibration (LMHFV); promotes angiogenesis, enhances muscle bulk and accelerates epithelization. Investigation on diabetic rats with foot wounds found accelerated wound healing, increased perfusion and upregulation of factors such as VEGF, PECAM-1 and PCNA. Hypothesis: We postulate LMHFV will enhance diabetic foot ulcer healing.
Methods: Prospective, single-centre, randomised control trial to treat 106 subjects with diabetic foot ulcers.
Interventions: The intervention group will stand on LMHFV whole-body vibration platforms for 20min on alternate days for 20 weeks, together with conventional dressing by a trained wound-care nurse as in the control group.
Main Outcome Measures: Ulcer size will be measured at multiple time points, the incidence of amputations/infections will be recorded, perfusion via ankle-brachial pressure index will be calculated and foot function via the foot and ankle outcome score will be analysed.
Data analysis: Repeated measure of ANOVA to analyze time-point differences and student’s t-test for same time-point comparison.
Discussion: This is the first clinical trial to investigate the effect of whole-body vibration on diabetic foot ulcers. It will show us if the results from animal studies will translate into clinically significant results. If positive effects are established, whole-body vibration can be a valuable treatment regime to tackle diabetic foot ulcers.
Methods: Prospective, single-centre, randomised control trial to treat 106 subjects with diabetic foot ulcers.
Interventions: The intervention group will stand on LMHFV whole-body vibration platforms for 20min on alternate days for 20 weeks, together with conventional dressing by a trained wound-care nurse as in the control group.
Main Outcome Measures: Ulcer size will be measured at multiple time points, the incidence of amputations/infections will be recorded, perfusion via ankle-brachial pressure index will be calculated and foot function via the foot and ankle outcome score will be analysed.
Data analysis: Repeated measure of ANOVA to analyze time-point differences and student’s t-test for same time-point comparison.
Discussion: This is the first clinical trial to investigate the effect of whole-body vibration on diabetic foot ulcers. It will show us if the results from animal studies will translate into clinically significant results. If positive effects are established, whole-body vibration can be a valuable treatment regime to tackle diabetic foot ulcers.
著者Ling Kin Ka Samuel , Hung Lam Cheuk Natalie , Cheung Wing-Hoi , Yung Shu-Hang Patrick
期刊名稱Research Square
出版作品名稱Research Square
出版年份2021
月份6
電子國際標準期刊號2693-5015
語言美式英語
