NCT01762085

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

3.5 years

First QC Date

January 3, 2013

Last Update Submit

June 25, 2015

Conditions

Diabetic Ulcer of Plantar Aspect of Left FootDiabetic Ulcer of Plantar Aspect of Right FootDiabetic Polyneuropathy

Keywords

neuropathic diabetic foot ulcernerve decompression surgery

Outcome Measures

Primary Outcomes (1)

  • occurrence of plantar foot ulceration wound

    Non- traumatic pressure wound or ulcer appearance during the study.

    2 years post-enrollment or post-op

Secondary Outcomes (2)

  • occurrence of delayed wound healing

    3 months post nerve decompression

  • Visual Analog Pain Score

    2 years

Other Outcomes (7)

  • any amputation

    24 months, 2 years

  • surgical wound infection

    3 months

  • non-surgical foot infection

    24 months

  • +4 more other outcomes

Study Arms (2)

healed DFU control arm

PLACEBO COMPARATOR

clinic-specific usual "best care"

healed DFU surgical intervention

EXPERIMENTAL

clinic-specific "best care" plus nerve decompression at 4 known sites of lower leg fibro-osseous entrapment

Procedure: nerve decompression

Interventions

nerve decompressionPROCEDURE

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

Also known as: nerve release, external neurolysis, surgical decompression
healed DFU surgical intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Barrett Foot & Ankle Institute

Phoenix, Arizona, 85024, United States

RECRUITING

Richard P. Jacoby

Scottsdale, Arizona, 85251, United States

RECRUITING

Southern Arizona Limb Salvage Alliance,

Tucson, Arizona, 85724-5072, United States

RECRUITING

Andrew Rader, DPM

Jasper, Indiana, 47546, United States

RECRUITING

Damien Dauphinee

Denton, Texas, 76210, United States

RECRUITING

Maria Buitrago, DPM

Houston, Texas, 77092, United States

RECRUITING

Related 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. doi: 10.1097/01.sap.0000143605.60384.4e.

    PMID: 15602245BACKGROUND

  • 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.

    PMID: 12271732BACKGROUND

  • 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.

    PMID: 17985566BACKGROUND

  • 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.

    PMID: 20237362BACKGROUND

  • 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.

    PMID: 22411624BACKGROUND

  • 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.

    PMID: 3355053BACKGROUND

  • 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.

    PMID: 1546082BACKGROUND

  • 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.

    PMID: 26055081BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Decompression, Surgical

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • D. Scott Nickerson, MD

    NE Wyoming Wound Care Center, consultant

    STUDY DIRECTOR

  • Stephen L. Barrett, DPM

    Barrett Foot & Ankle Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Barrett, DPM

CONTACT

623 572-3456slbarrettpod@me.com

D. Scott Nickerson, MD

CONTACT

307 752-9875thenix@fiberpipe.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 7, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 26, 2015

Record last verified: 2015-06

Locations

US(6)