Nerve Decompression for Ulcer Recurrence Avoidance (DURA) (DURA)
2015年6月25日 更新者：Association of Extremity Nerve Surgeons
A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression
Anecdotal reports and scientific literature suggest that the risk of recurrence of diabetic foot ulcers can be minimized by nerve decompression procedures at anatomic sites of nerve pinching and entrapment.
Historical risk of 25% annually has been reported to decrease by >80% to under 5% yearly.
Since an open wound precedes the large majority (85%) of amputations in diabetes, avoidance of ulcer recurrences is important.
This study tests the current academic opinion that nerve decompression will not decrease ulcer recurrence risk.
Null hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.
研究概览
地位
未知
条件
干预/治疗
详细说明
Diabetes patients with a recently healed, non-ischemic plantar diabetic foot ulcer will be randomized to "best care" standard post-ulcer treatment or to best care plus bilateral nerve decompression by external neurolysis at 4 fibro-osseous tunnel sites in the leg and foot. Comparison of the control group with standard care to the surgical intervention group will be made for subsequent appearance of a plantar foot ulcer and ulcer recurrence risks will be calculated. Additional subjective and objective secondary outcomes will be monitored. Null hypothesis: nerve decompression will not decrease diabetic foot ulcer recurrence risk.
If protection against ulcer occurrence were to be confirmed, a change in the treatment paradigm for diabetic neuropathy and foot ulcer could be appropriate.
研究类型
介入性
注册 (预期的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Arizona
-
Phoenix、Arizona、美国、85024
- 招聘中
- Barrett Foot & Ankle Institute
-
接触：
- Steven L Barrett, DPM
- 电话号码：480-478-0780
- 邮箱：slbarrettpod@me.com
-
接触：
- John C Tassone, DPM
- 电话号码：(602) 938-6960
- 邮箱：jctassone@cox.net
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首席研究员：
- Stephen L Barrett, DPM
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Scottsdale、Arizona、美国、85251
- 招聘中
- Richard P. Jacoby
-
接触：
- Richard P Jacoby, DPM
- 电话号码：480-994-5977
- 邮箱：jacobydpm@gmail.com
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首席研究员：
- Richard P Jacoby, DPM
-
Tucson、Arizona、美国、85724-5072
- 招聘中
- Southern Arizona Limb Salvage Alliance,
-
接触：
- Manish Bharara, PhD
- 电话号码：520-626-1349
- 邮箱：manish.bharara@gmail.com
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接触：
- David Armstrong, DPM
- 电话号码：(520) 626-1349
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首席研究员：
- Manish Bharara, PhD
-
-
Indiana
-
Jasper、Indiana、美国、47546
- 招聘中
- Andrew Rader, DPM
-
接触：
- Andrew P Rader, DPM
- 电话号码：812-634-2778
- 邮箱：pvppc@psci.net
-
首席研究员：
- Andrew P Rader, DPM
-
-
Texas
-
Denton、Texas、美国、76210
- 招聘中
- Damien Dauphinee
-
接触：
- Damien Dauphinee, DPM
- 电话号码：940-300-3054
- 邮箱：dauphinee@completefootandanklecare.com
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首席研究员：
- Damien Dauphinee, DPM
-
Houston、Texas、美国、77092
- 招聘中
- Maria Buitrago, DPM
-
接触：
- Maria Buitrago, DPM
- 电话号码：713-680-3668
- 邮箱：mobui@hotmail.com
-
首席研究员：
- Maria Buitrago, DPM
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Type 1 or Type 2 Diabetes Mellitus
- Diabetic sensorimotor peripheral neuropathy
- Recently healed plantar neuropathic Diabetic Foot Ulcer (< 18 months)
- At least one palpable foot or ankle pulse or ABI>0.8 bilaterally.
- Recent Hgb A1c < 9.0%
- Ankle edema absent or mild
Exclusion Criteria:
- Ischemic peripheral vascular disease or ankle-brachial index (ABI)<0.8
- History of peripheral vascular arterial surgery
- History of peripheral nerve or lumbar disc surgery
- alcohol abuse(more than 2 drinks/day)
- untreated thyroid disorders
- B12 or Folate deficiency
- spondyloarthropathies
- hepatic disease
- advanced renal disease
- current lumbosacral radiculopathy or nerve compression
- toxin exposure including chemotherapeutic agents
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：healed DFU control arm
clinic-specific usual "best care"
|
|
|
实验性的：healed DFU surgical intervention
clinic-specific "best care" plus nerve decompression at 4 known sites of lower leg fibro-osseous entrapment
|
surgical decompression involves surgical division or incision of perineural fibrous or fibro-osseous tunnel tissues which pinch, choke, compress or sharply deviate nerve trunks.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
occurrence of plantar foot ulceration wound
大体时间：2 years post-enrollment or post-op
|
Non- traumatic pressure wound or ulcer appearance during the study.
|
2 years post-enrollment or post-op
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
occurrence of delayed wound healing
大体时间：3 months post nerve decompression
|
failure of surgical wound to heal primarily, without local infection signs of swelling, heat, redness, and pain
|
3 months post nerve decompression
|
|
Visual Analog Pain Score
大体时间：2 years
|
Patient report of pain level
|
2 years
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
any amputation
大体时间：24 months, 2 years
|
surgical removal of any part of the lower extremity, including toe
|
24 months, 2 years
|
|
surgical wound infection
大体时间：3 months
|
swelling, redness, or heat, with pain after surgery
|
3 months
|
|
non-surgical foot infection
大体时间：24 months
|
foot swelling, redness, pain, and heat not subsequent to operation; or occurring in an operated leg >90 days post-op
|
24 months
|
|
measures of diabetic peripheral neuropathy (DPN)
大体时间：2 years
|
Michigan Neuropathy Symptom Index; Pain visual analog pain scale (VAPS); sensibility to vibration, light touch, 2-point discrimination; deep tendon reflex
|
2 years
|
|
analgesic usage
大体时间：2 years
|
patients will log use of analgesic medications and changes in use.
|
2 years
|
|
SPY Indocyanine green circulation evaluation
大体时间：pre-opo, post-op, study end
|
This intravenous injection and non-invasive scan evaluation may indicate whether relief of nerve entrapment will alter macro or microcirculation
|
pre-opo, post-op, study end
|
|
Incidence of falls during the study
大体时间：2 years
|
Prior history of falls will be defined and changes in risk of new falls in control and intervention groups.
Balance has been reported to improve after nerve decompression.
|
2 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：D. Scott Nickerson, MD、NE Wyoming Wound Care Center, consultant
- 首席研究员：Stephen L. Barrett, DPM、Barrett Foot & Ankle Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Aszmann O, Tassler PL, Dellon AL. Changing the natural history of diabetic neuropathy: incidence of ulcer/amputation in the contralateral limb of patients with a unilateral nerve decompression procedure. Ann Plast Surg. 2004 Dec;53(6):517-22. doi: 10.1097/01.sap.0000143605.60384.4e.
- Dellon AL. Preventing foot ulceration and amputation by decompressing peripheral nerves in patients with diabetic neuropathy. Ostomy Wound Manage. 2002 Sep;48(9):36-45.
- Dellon AL. Neurosurgical prevention of ulceration and amputation by decompression of lower extremity peripheral nerves in diabetic neuropathy: update 2006. Acta Neurochir Suppl. 2007;100:149-51. doi: 10.1007/978-3-211-72958-8_32.
- Nickerson DS. Low recurrence rate of diabetic foot ulcer after nerve decompression. J Am Podiatr Med Assoc. 2010 Mar-Apr;100(2):111-5. doi: 10.7547/1000111.
- Dellon AL, Muse VL, Nickerson DS, Akre T, Anderson SR, Barrett SL, Biddinger KR, Bregman PJ, Bullard BP, Dauphinee DM, DeJesus JM, DeJesus RA, Ducic I, Dunkerly J, Galina MR, Hung V, Ichtertz DR, Kutka MF, Jacoby RP, Johnson JB, Mader DW, Maloney CT Jr, Mancuso PJ, Martin RC, Martin RF, McDowel BA, Rizzo VJ, Rose M, Rosson GD, Shafiroff BB, Steck JK, Stolarski RG, Swier P, Wellens-Bruschayt TA, Wilke B, Williams EH, Wood MA, Wood WA, Younes MP, Yuksel F. Prevention of ulceration, amputation, and reduction of hospitalization: outcomes of a prospective multicenter trial of tibial neurolysis in patients with diabetic neuropathy. J Reconstr Microsurg. 2012 May;28(4):241-6. doi: 10.1055/s-0032-1306372. Epub 2012 Mar 12.
- Dellon AL. A cause for optimism in diabetic neuropathy. Ann Plast Surg. 1988 Feb;20(2):103-5. doi: 10.1097/00000637-198802000-00001. No abstract available.
- Dellon AL. Treatment of symptomatic diabetic neuropathy by surgical decompression of multiple peripheral nerves. Plast Reconstr Surg. 1992 Apr;89(4):689-97; discussion 698-9.
- Rankin TM, Miller JD, Gruessner AC, Nickerson DS. Illustration of Cost Saving Implications of Lower Extremity Nerve Decompression to Prevent Recurrence of Diabetic Foot Ulceration. J Diabetes Sci Technol. 2015 Jul;9(4):873-80. doi: 10.1177/1932296815584796. Epub 2015 Jun 8.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年6月1日
初级完成 (预期的)
2016年12月1日
研究完成 (预期的)
2016年12月1日
研究注册日期
首次提交
2013年1月3日
首先提交符合 QC 标准的
2013年1月4日
首次发布 (估计)
2013年1月7日
研究记录更新
最后更新发布 (估计)
2015年6月26日
上次提交的符合 QC 标准的更新
2015年6月25日
最后验证
2015年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.