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Nerve Decompression for Ulcer Recurrence Avoidance (DURA) (DURA)

Primary Purpose

Diabetic Ulcer of Plantar Aspect of Left Foot, Diabetic Ulcer of Plantar Aspect of Right Foot, Diabetic Polyneuropathy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nerve decompression
Sponsored by
Association of Extremity Nerve Surgeons
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Ulcer of Plantar Aspect of Left Foot focused on measuring neuropathic diabetic foot ulcer, nerve decompression surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barrett Foot & Ankle InstituteRecruiting
  • Richard P. JacobyRecruiting
  • Southern Arizona Limb Salvage Alliance,Recruiting
  • Andrew Rader, DPMRecruiting
  • Damien DauphineeRecruiting
  • Maria Buitrago, DPMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

healed DFU control arm

healed DFU surgical intervention

Arm Description

clinic-specific usual "best care"

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

Outcomes

Primary Outcome Measures

occurrence of plantar foot ulceration wound
Non- traumatic pressure wound or ulcer appearance during the study.

Secondary Outcome Measures

occurrence of delayed wound healing
failure of surgical wound to heal primarily, without local infection signs of swelling, heat, redness, and pain
Visual Analog Pain Score
Patient report of pain level

Full Information

First Posted
January 3, 2013
Last Updated
June 25, 2015
Sponsor
Association of Extremity Nerve Surgeons
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1. Study Identification

Unique Protocol Identification Number
NCT01762085
Brief Title
Nerve Decompression for Ulcer Recurrence Avoidance (DURA)
Acronym
DURA
Official Title
A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association of Extremity Nerve Surgeons

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
healed DFU control arm
Arm Type
Placebo Comparator
Arm Description
clinic-specific usual "best care"
Arm Title
healed DFU surgical intervention
Arm Type
Experimental
Arm Description
clinic-specific "best care" plus nerve decompression at 4 known sites of lower leg fibro-osseous entrapment
Intervention Type
Procedure
Intervention Name(s)
nerve decompression
Other Intervention Name(s)
nerve release, external neurolysis, surgical decompression
Intervention Description
surgical decompression involves surgical division or incision of perineural fibrous or fibro-osseous tunnel tissues which pinch, choke, compress or sharply deviate nerve trunks.
Primary Outcome Measure Information:
Title
occurrence of plantar foot ulceration wound
Description
Non- traumatic pressure wound or ulcer appearance during the study.
Time Frame
2 years post-enrollment or post-op
Secondary Outcome Measure Information:
Title
occurrence of delayed wound healing
Description
failure of surgical wound to heal primarily, without local infection signs of swelling, heat, redness, and pain
Time Frame
3 months post nerve decompression
Title
Visual Analog Pain Score
Description
Patient report of pain level
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
any amputation
Description
surgical removal of any part of the lower extremity, including toe
Time Frame
24 months, 2 years
Title
surgical wound infection
Description
swelling, redness, or heat, with pain after surgery
Time Frame
3 months
Title
non-surgical foot infection
Description
foot swelling, redness, pain, and heat not subsequent to operation; or occurring in an operated leg >90 days post-op
Time Frame
24 months
Title
measures of diabetic peripheral neuropathy (DPN)
Description
Michigan Neuropathy Symptom Index; Pain visual analog pain scale (VAPS); sensibility to vibration, light touch, 2-point discrimination; deep tendon reflex
Time Frame
2 years
Title
analgesic usage
Description
patients will log use of analgesic medications and changes in use.
Time Frame
2 years
Title
SPY Indocyanine green circulation evaluation
Description
This intravenous injection and non-invasive scan evaluation may indicate whether relief of nerve entrapment will alter macro or microcirculation
Time Frame
pre-opo, post-op, study end
Title
Incidence of falls during the study
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Barrett, DPM
Phone
623 572-3456
Email
slbarrettpod@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
D. Scott Nickerson, MD
Phone
307 752-9875
Email
thenix@fiberpipe.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. Scott Nickerson, MD
Organizational Affiliation
NE Wyoming Wound Care Center, consultant
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stephen L. Barrett, DPM
Organizational Affiliation
Barrett Foot & Ankle Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrett Foot & Ankle Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven L Barrett, DPM
Phone
480-478-0780
Email
slbarrettpod@me.com
First Name & Middle Initial & Last Name & Degree
John C Tassone, DPM
Phone
(602) 938-6960
Email
jctassone@cox.net
First Name & Middle Initial & Last Name & Degree
Stephen L Barrett, DPM
Facility Name
Richard P. Jacoby
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard P Jacoby, DPM
Phone
480-994-5977
Email
jacobydpm@gmail.com
First Name & Middle Initial & Last Name & Degree
Richard P Jacoby, DPM
Facility Name
Southern Arizona Limb Salvage Alliance,
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5072
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish Bharara, PhD
Phone
520-626-1349
Email
manish.bharara@gmail.com
First Name & Middle Initial & Last Name & Degree
David Armstrong, DPM
Phone
(520) 626-1349
First Name & Middle Initial & Last Name & Degree
Manish Bharara, PhD
Facility Name
Andrew Rader, DPM
City
Jasper
State/Province
Indiana
ZIP/Postal Code
47546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew P Rader, DPM
Phone
812-634-2778
Email
pvppc@psci.net
First Name & Middle Initial & Last Name & Degree
Andrew P Rader, DPM
Facility Name
Damien Dauphinee
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien Dauphinee, DPM
Phone
940-300-3054
Email
dauphinee@completefootandanklecare.com
First Name & Middle Initial & Last Name & Degree
Damien Dauphinee, DPM
Facility Name
Maria Buitrago, DPM
City
Houston
State/Province
Texas
ZIP/Postal Code
77092
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Buitrago, DPM
Phone
713-680-3668
Email
mobui@hotmail.com
First Name & Middle Initial & Last Name & Degree
Maria Buitrago, DPM

12. IPD Sharing Statement

Citations:
PubMed Identifier
15602245
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.
Results Reference
background
PubMed Identifier
12271732
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.
Results Reference
background
PubMed Identifier
17985566
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.
Results Reference
background
PubMed Identifier
20237362
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.
Results Reference
background
PubMed Identifier
22411624
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.
Results Reference
background
PubMed Identifier
3355053
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.
Results Reference
background
PubMed Identifier
1546082
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.
Results Reference
background
PubMed Identifier
26055081
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.
Results Reference
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Nerve Decompression for Ulcer Recurrence Avoidance (DURA)

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