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.
Full Title of Study: “A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: December 2016
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.
- 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.
Arms, Groups and Cohorts
- 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
Clinical Trial Outcome Measures
- 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.
- 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
- Visual Analog Pain Score
- Time Frame: 2 years
- Patient report of pain level
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Association of Extremity Nerve Surgeons
- Provider of Information About this Clinical Study
- Overall Official(s)
- D. Scott Nickerson, MD, Study Director, NE Wyoming Wound Care Center, consultant
- Stephen L. Barrett, DPM, Principal Investigator, Barrett Foot & Ankle Institute
- Overall Contact(s)
- Stephen Barrett, DPM, 623 572-3456, email@example.com
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.
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.
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.
Nickerson DS. Low recurrence rate of diabetic foot ulcer after nerve decompression. J Am Podiatr Med Assoc. 2010 Mar-Apr;100(2):111-5.
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.
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.
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.