Clinical trial NCT01762085: Nerve Decompression for Ulcer Recurrence Avoidance (DURA)
Official title: A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Ulcer of Plantar Aspect of Left Foot
Diabetic Ulcer of Plantar Aspect of Right Foot
Diabetic Polyneuropathy
Keywords: neuropathic diabetic foot ulcer
nerve decompression surgery
Lead sponsor: Association of Extremity Nerve Surgeons
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: occurrence of plantar foot ulceration wound
timeFrame: 2 years post-enrollment or post-op
Secondary outcomes:
measure: occurrence of delayed wound healing
timeFrame: 3 months post nerve decompression
measure: Visual Analog Pain Score
timeFrame: 2 years
Other outcomes:
measure: any amputation
timeFrame: 24 months, 2 years
measure: surgical wound infection
timeFrame: 3 months
measure: non-surgical foot infection
timeFrame: 24 months
measure: measures of diabetic peripheral neuropathy (DPN)
timeFrame: 2 years
measure: analgesic usage
timeFrame: 2 years
measure: SPY Indocyanine green circulation evaluation
timeFrame: pre-opo, post-op, study end
measure: Incidence of falls during the study
timeFrame: 2 years
Locations:
city: Phoenix
country: United States
facility: Barrett Foot & Ankle Institute
state: Arizona
city: Scottsdale
country: United States
facility: Richard P. Jacoby
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona Limb Salvage Alliance,
state: Arizona
city: Jasper
country: United States
facility: Andrew Rader, DPM
state: Indiana
city: Denton
country: United States
facility: Damien Dauphinee
state: Texas
city: Houston
country: United States
facility: Maria Buitrago, DPM
state: Texas
Study officials:
affiliation: NE Wyoming Wound Care Center, consultant
name: D. Scott Nickerson, MD
role: STUDY_DIRECTOR
affiliation: Barrett Foot & Ankle Institute
name: Stephen L. Barrett, DPM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.