Enhancement of Diabetic Foot Ulcer Healing Using Low-Magnitude High-Frequency Vibration Treatment - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 106
- 主要终点
- Ulcer size
研究概览
简要总结
Objectives:
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:
The investigators postulate LMHFV will enhance diabetic foot ulcer healing.
Design and Subjects:
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.
Expected Results:
This is the first clinical trial to investigate the effect of whole-body vibration on diabetic foot ulcers. It will show the investigators 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.
详细描述
Plan of Investigation: (fig 04 in supplementary notes, CONSORT diagram)
Subjects:
Participants will be recruited from the patients in the Orthopaedic & Traumatology department at the Prince of Wales Hospital, the tertiary teaching hospital affiliated to CUHK.
Sample size: 106 subjects randomized 1:1 into the two treatment groups accounting for a dropout rate of 15%.
The sample size was calculated by using the primary endpoint of wound size in G*Power 3.1.9.4 (Germany). Using a 1:1 randomization ratio a type I error rate (a-level) of 0.05 and power of 0.95. Our vibration study of diabetic rat wounds showed an effect size d of 0.99. We estimate a tuned-down effect in human subjects, thus using an effect size of 0.7 we calculated that we should recruit 90 participants with 45 in each group. (22)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Ulcer size
时间窗: 0weeks, 2weeks, 8weeks, 14weeks, 20weeks, 56weeks
• The baseline ulcer size will be measured at 0 weeks and a core interim measurement will be conducted at 20 weeks since 30% of ulcerations will heal at 20 weeks using conventional dressing. (13) A 1-year reassessment will help differentiate if the 20-week course of LMHFV therapy has created sustainable changes.
次要结局
- Perfusion(0weeks, 20weeks)
- Foot function(0weeks, 20weeks)
- Incidence of secondary infection(up to 56 weeks)
- Time (days) to healing(up to 56 weeks)
- Incidence of amputation(up to 56 weeks)
研究者
Samuel KK Ling
Clinical Assistant Professor
Chinese University of Hong Kong