Diabetic Ulcer of Plantar Aspect of Left FootDURANCT01762085
Nerve Decompression for Ulcer Recurrence Avoidance (DURA)
A study testing nerve decompression in people with Diabetic Ulcer of Plantar Aspect of Left Foot and Diabetic Ulcer of Plantar Aspect of Right Foot, run by Association of Extremity Nerve Surgeons at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Ulcer of Plantar Aspect of Left Foot, Diabetic Ulcer of Plantar Aspect of Right Foot, Diabetic Polyneuropathy
- What is being tested?
- nerve decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- spondyloarthropathies
- hepatic disease
- advanced renal disease
- current lumbosacral radiculopathy or nerve compression
- toxin exposure including chemotherapeutic agents
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Damien Dauphinee
Denton, Texas, 76210
Damien Dauphinee, DPM, 940-300-3054, dauphinee@completefootandanklecare.com
Damien Dauphinee, DPM
- Recruiting
Maria Buitrago, DPM
Houston, Texas, 77092
Maria Buitrago, DPM, 713-680-3668, mobui@hotmail.com
Maria Buitrago, DPM
- Recruiting
Andrew Rader, DPM
Jasper, Indiana, 47546
Andrew P Rader, DPM, 812-634-2778, pvppc@psci.net
Andrew P Rader, DPM
- Recruiting
Barrett Foot & Ankle Institute
Phoenix, Arizona, 85024
Steven L Barrett, DPM, 480-478-0780, slbarrettpod@me.com
John C Tassone, DPM, (602) 938-6960, jctassone@cox.net
- Recruiting
Richard P. Jacoby
Scottsdale, Arizona, 85251
Richard P Jacoby, DPM, 480-994-5977, jacobydpm@gmail.com
Richard P Jacoby, DPM
- Recruiting
Southern Arizona Limb Salvage Alliance,
Tucson, Arizona, 85724-5072
Manish Bharara, PhD, 520-626-1349, manish.bharara@gmail.com
David Armstrong, DPM, (520) 626-1349
About this study
Official title: A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression
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.
Read the 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.
- Conditions
- Diabetic Ulcer of Plantar Aspect of Left Foot, Diabetic Ulcer of Plantar Aspect of Right Foot, Diabetic Polyneuropathy
- Being tested
- nerve decompression
- Keywords
- neuropathic diabetic foot ulcer, nerve decompression surgery
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve decompressionProcedure or surgery
Also called nerve release, external neurolysis, surgical 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: nerve decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of plantar foot ulceration wound
Non- traumatic pressure wound or ulcer appearance during the study.
Measured: 2 years post-enrollment or post-op
Secondary outcomes (2)
occurrence of delayed wound healing
failure of surgical wound to heal primarily, without local infection signs of swelling, heat, redness, and pain
Measured: 3 months post nerve decompression
Visual Analog Pain Score
Patient report of pain level
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetic Ulcer of Plantar Aspect of Left FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association of Extremity Nerve Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- D. Scott Nickerson, MD, Study director, NE Wyoming Wound Care Center, consultantStephen L. Barrett, DPM, Principal investigator, Barrett Foot & Ankle Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762085
- Sponsor's protocol ID
- WIRB 20122035
- Other IDs
- Nerve DURA
- Acronym
- DURA
- Status last verified
- Jun 2015
- First submitted
- 3 Jan 2013
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15602245Dellon AL. Preventing foot ulceration and amputation by decompressing peripheral nerves in patients with diabetic neuropathy. Ostomy Wound Manage. 2002 Sep;48(9):36-45.
PubMed 12271732Dellon 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.
PubMed 17985566Nickerson 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.
PubMed 20237362Dellon 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.
PubMed 22411624Dellon 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.
PubMed 3355053Dellon 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.
PubMed 1546082Rankin 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.
PubMed 26055081
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression
- ClinicalTrials.gov ID
- NCT01762085
- Acronym / sponsor ID
- DURA / WIRB 20122035
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Association of Extremity Nerve SurgeonsUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healed DFU control arm | Placebo comparator | –clinic-specific usual "best care" |
| healed DFU surgical intervention | Experimental | Procedure: nerve decompressionclinic-specific "best care" plus nerve decompression at 4 known sites of lower leg fibro-osseous entrapment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nerve decompressionAlso: nerve release, external neurolysis, surgical decompressionsurgical decompression involves surgical division or incision of perineural fibrous or fibro-osseous tunnel tissues which pinch, choke, compress or sharply deviate nerve trunks. | Procedure or surgery | healed DFU surgical intervention |
Primary outcome
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.
2 secondary outcomes
occurrence of delayed wound healing
Time frame: 3 months post nerve decompression
Visual Analog Pain Score
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
- Background: PubMed 15602245Aszmann 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.
- Background: PubMed 12271732Dellon AL. Preventing foot ulceration and amputation by decompressing peripheral nerves in patients with diabetic neuropathy. Ostomy Wound Manage. 2002 Sep;48(9):36-45.
- Background: PubMed 17985566Dellon 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.
- Background: PubMed 20237362Nickerson 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.
- Background: PubMed 22411624Dellon 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.
- Background: PubMed 3355053Dellon 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.
- Background: PubMed 1546082Dellon 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.
- Background: PubMed 26055081Rankin 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D. Scott Nickerson, MD study director
NE Wyoming Wound Care Center, consultant
Stephen L. Barrett, DPM principal investigator
Barrett Foot & Ankle Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nerve decompression in people with Diabetic Ulcer of Plantar Aspect of Left Foot and Diabetic Ulcer of Plantar Aspect of Right Foot, run by Association of Extremity Nerve Surgeons at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Barrett, DPM (623 572-3456, slbarrettpod@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of plantar foot ulceration wound (time frame: 2 years post-enrollment or post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01762085, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015; AzTrials last refreshed its copy on 27 Oct 2026.