Botulinum Toxin Effects on Plantar Ulcer Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Plantar Flexor Muscle Strength
研究概览
简要总结
The purpose of this grant is to collect pilot data to assess the amount of botulinum toxin that needs to be injected into the calf muscles of subjects with diabetes mellitus, peripheral neuropathy, and a plantar ulcer to decrease muscle strength. We hypothesize that a decrease in plantar flexor muscle strength will temporarily decrease plantar pressure. The decrease in plantar pressure will provide temporary protection to the new tissue as it gains tolerance to high stress with the long term potential outcome as a decrease in the ulcer recurrence rate.
详细描述
Please read "Brief Summary"
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetes mellitus and determination of diminished or absent plantar sensation
- •A recurrent forefoot plantar ulcer; at least the second occurrence of a plantar ulcer or a previous failure to heal a plantar ulcer with reasonable treatment intervention (Total contact casting, off loading boot, molded ankle foot orthotic, Gillette, or therapeutic footwear modifications)
- •Ambulatory
排除标准
- •Active infection in the involved foot
- •Previous botulinum toxin injections
- •Ulcers on the dorsal surface of the foot
- •Ankle-brachial index <0.45
- •History of cerebral vascular accident or other neurological problems complicating their rehabilitation
- •Women of childbearing years unless pregnancy test is agreed upon, completed, and negative and agree to use some form of contraception during the study.
- •Current drug therapy that includes an anticoagulant
- •History of a neuromuscular disease, except peripheral neuropathy as a result of diabetes mellitus
研究组 & 干预措施
1
Placebo (saline) injections into 6 sites in the calf muscle
干预措施: Saline (Drug)
2
Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
干预措施: Botulinum Toxin (Drug)
3
300 units of botulinum toxin injected into 6 sites in the calf muscle
干预措施: Botulinum Toxin (Drug)
结局指标
主要结局
Plantar Flexor Muscle Strength
时间窗: Pre-treatment, 2 weeks after injection, upon ulcer healing, 3 months and 6 months after ulcer healing
Concentric plantar flexor torque was assessed using the Biodex System 3 Pro Orthopedic Testing \& Rehabilitation dynamometer. Plantar flexor peak torque was measured at 60 deg/sec, which is comparable to the angular velocity of the ankle joint during the stance phase of walking. Three trials of each foot were completed. Peak torque was calculated as the average of the two highest torque values across trials and results were expressed as Nm. A positive value represents an increase in torque while a negative value represents a decrease in torque.
次要结局
- Barefoot Plantar Pressure(pre-injection, 2 weeks post injection, post healing, and 3 and 6 months post healing)
研究者
Mary Hastings, PT, DPT, ATC
Assistant Professor
Washington University School of Medicine