Trials / Unknown
UnknownNCT01762085
Nerve Decompression for Ulcer Recurrence Avoidance (DURA)
A Prospective Study of Recurrence Risk in Diabetic Foot Ulceration After Nerve Decompression
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Association of Extremity Nerve Surgeons · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Diabetic Ulcer of Plantar Aspect of Left Foot
- Diabetic Ulcer of Plantar Aspect of Right Foot
- Diabetic Polyneuropathy
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2013-01-07
- Last updated
- 2015-06-26
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01762085. Inclusion in this directory is not an endorsement.