Nerve Decompression for Ulcer Recurrence Avoidance (DURA)

Diabetic Polyneuropathy Clinical Trial

— DURA  

Official title:

A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01762085
• Other study ID #: WIRB 20122035
• Secondary ID: Nerve DURA
• Status: Recruiting
• Phase: N/A
• First received: January 3, 2013
• Last updated: June 25, 2015
• Start date: June 2013
• Est. completion date: December 2016

Study information

• Verified date: June 2015
• Source: Association of Extremity Nerve Surgeons
• Contact: Stephen Barrett, DPM
• Phone: 623 572-3456
• Email: slbarrettpod[@]me.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Diabetic Ulcer of Plantar Aspect of Left Foot
• Diabetic Ulcer of Plantar Aspect of Right Foot
• Polyneuropathies
• Ulcer

Intervention

Procedure:
• nerve decompression
surgical decompression involves surgical division or incision of perineural fibrous or fibro-osseous tunnel tissues which pinch, choke, compress or sharply deviate nerve trunks.

Locations

Country	Name	City	State
United States	Damien Dauphinee	Denton	Texas
United States	Maria Buitrago, DPM	Houston	Texas
United States	Andrew Rader, DPM	Jasper	Indiana
United States	Barrett Foot & Ankle Institute	Phoenix	Arizona
United States	Richard P. Jacoby	Scottsdale	Arizona
United States	Southern Arizona Limb Salvage Alliance,	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Association of Extremity Nerve Surgeons

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View Citation

Dellon AL. A cause for optimism in diabetic neuropathy. Ann Plast Surg. 1988 Feb;20(2):103-5. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	any amputation	surgical removal of any part of the lower extremity, including toe	24 months, 2 years	No
Other	surgical wound infection	swelling, redness, or heat, with pain after surgery	3 months	No
Other	non-surgical foot infection	foot swelling, redness, pain, and heat not subsequent to operation; or occurring in an operated leg >90 days post-op	24 months	No
Other	measures of diabetic peripheral neuropathy (DPN)	Michigan Neuropathy Symptom Index; Pain visual analog pain scale (VAPS); sensibility to vibration, light touch, 2-point discrimination; deep tendon reflex	2 years	No
Other	analgesic usage	patients will log use of analgesic medications and changes in use.	2 years	No
Other	SPY Indocyanine green circulation evaluation	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	No
Other	Incidence of falls during the study	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	Yes
Primary	occurrence of plantar foot ulceration wound	Non- traumatic pressure wound or ulcer appearance during the study.	2 years post-enrollment or post-op	No
Secondary	occurrence of delayed wound healing	failure of surgical wound to heal primarily, without local infection signs of swelling, heat, redness, and pain	3 months post nerve decompression	No
Secondary	Visual Analog Pain Score	Patient report of pain level	2 years	No