- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01762085
Nerve Decompression for Ulcer Recurrence Avoidance (DURA) (DURA)
A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stephen Barrett, DPM
- Phone Number: 623 572-3456
- Email: slbarrettpod@me.com
Study Contact Backup
- Name: D. Scott Nickerson, MD
- Phone Number: 307 752-9875
- Email: thenix@fiberpipe.net
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85024
- Recruiting
- Barrett Foot & Ankle Institute
-
Contact:
- Steven L Barrett, DPM
- Phone Number: 480-478-0780
- Email: slbarrettpod@me.com
-
Contact:
- John C Tassone, DPM
- Phone Number: (602) 938-6960
- Email: jctassone@cox.net
-
Principal Investigator:
- Stephen L Barrett, DPM
-
Scottsdale, Arizona, United States, 85251
- Recruiting
- Richard P. Jacoby
-
Contact:
- Richard P Jacoby, DPM
- Phone Number: 480-994-5977
- Email: jacobydpm@gmail.com
-
Principal Investigator:
- Richard P Jacoby, DPM
-
Tucson, Arizona, United States, 85724-5072
- Recruiting
- Southern Arizona Limb Salvage Alliance,
-
Contact:
- Manish Bharara, PhD
- Phone Number: 520-626-1349
- Email: manish.bharara@gmail.com
-
Contact:
- David Armstrong, DPM
- Phone Number: (520) 626-1349
-
Principal Investigator:
- Manish Bharara, PhD
-
-
Indiana
-
Jasper, Indiana, United States, 47546
- Recruiting
- Andrew Rader, DPM
-
Contact:
- Andrew P Rader, DPM
- Phone Number: 812-634-2778
- Email: pvppc@psci.net
-
Principal Investigator:
- Andrew P Rader, DPM
-
-
Texas
-
Denton, Texas, United States, 76210
- Recruiting
- Damien Dauphinee
-
Contact:
- Damien Dauphinee, DPM
- Phone Number: 940-300-3054
- Email: dauphinee@completefootandanklecare.com
-
Principal Investigator:
- Damien Dauphinee, DPM
-
Houston, Texas, United States, 77092
- Recruiting
- Maria Buitrago, DPM
-
Contact:
- Maria Buitrago, DPM
- Phone Number: 713-680-3668
- Email: mobui@hotmail.com
-
Principal Investigator:
- Maria Buitrago, DPM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: healed DFU control arm
clinic-specific usual "best care"
|
|
Experimental: 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
occurrence of plantar foot ulceration wound
Time Frame: 2 years post-enrollment or post-op
|
Non- traumatic pressure wound or ulcer appearance during the study.
|
2 years post-enrollment or post-op
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
occurrence of delayed wound healing
Time Frame: 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
Time Frame: 2 years
|
Patient report of pain level
|
2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
any amputation
Time Frame: 24 months, 2 years
|
surgical removal of any part of the lower extremity, including toe
|
24 months, 2 years
|
surgical wound infection
Time Frame: 3 months
|
swelling, redness, or heat, with pain after surgery
|
3 months
|
non-surgical foot infection
Time Frame: 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)
Time Frame: 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
Time Frame: 2 years
|
patients will log use of analgesic medications and changes in use.
|
2 years
|
SPY Indocyanine green circulation evaluation
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Investigators
- Study Director: D. Scott Nickerson, MD, NE Wyoming Wound Care Center, consultant
- Principal Investigator: Stephen L. Barrett, DPM, Barrett Foot & Ankle Institute
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WIRB 20122035
- Nerve DURA (Other Grant/Funding Number: AENS/ENRF)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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