Clinical Information & Referral

Physician Information & Referral

The D.U.R.A. Study (ClinicalTrials.gov NCT01762085) is an IRB-approved clinical trial sponsored by the Association of Extremity Nerve Surgeons (AENS), evaluating whether lower-extremity nerve decompression may reduce recurrent neuropathic ulceration in appropriately selected patients.

Study Registration

Protocol Summary: NCT01762085

View on ClinicalTrials.gov

Official Title:

Decompression of Lower Extremity Nerves to Prevent Recurrence of Diabetic Foot Ulcers

Lead Investigator:

Dr. Sequoia DuCasse, DPM, FACFAS, FAENS

Sponsor:

Association of Extremity Nerve Surgeons (AENS)

Intervention:

Lower-extremity nerve decompression (tarsal tunnel, common peroneal, deep peroneal)

Primary Endpoint:

Ulcer-free survival and reduction in recurrent neuropathic ulceration

Trial Setting:

Ambulatory surgical site; post-operative sensory mapping follow-up

Protocol details above are summarized from the study registration. Confirm current details against the ClinicalTrials.gov record before referral.

Study Rationale & Hypothesis

Diabetic peripheral neuropathy is a well-established complication of diabetes that reduces protective sensation and contributes to recurrent plantar ulceration. In some patients, researchers hypothesize that nerve compression at anatomical fibro-osseous tunnels may contribute additional nerve dysfunction — a proposed "double-crush" mechanism.

Previous observational studies and historical control cohorts have reported lower ulcer-recurrence rates following nerve decompression in selected patients. However, observational evidence has important limitations and does not establish that nerve decompression prevents recurrent ulcers.

The D.U.R.A. Study is evaluating this question prospectively under IRB-approved conditions. It is not presenting historical outcomes as its own results, and it does not claim established effectiveness for the procedure.

Inclusion / Exclusion Overview

The following is a general overview. Authoritative criteria are defined in the study protocol and informed consent; confirm against the ClinicalTrials.gov record before referral.

Inclusion (Overview)

Documented Type 1 or Type 2 Diabetes Mellitus.
History of a healed plantar or digital diabetic neuropathic ulcer.
Loss of protective sensation (e.g., inability to perceive 10g 5.07 Semmes-Weinstein monofilament).
Positive percussion (Tinel sign) at one or more lower-extremity tunnel sites.
Adequate arterial perfusion (e.g., palpable pulses or ABI ≥ 0.7–0.8).

Exclusion (Overview)

Active open, draining ulceration or acute localized tissue infection at screening.
Severe peripheral vascular disease unsuitable for elective outpatient surgery.
Active osteomyelitis or advanced uncorrected Charcot neuroarthropathy.
Uncontrolled medical comorbidity precluding outpatient local/regional anesthesia.

Published Evidence & References

The scientific rationale draws on published extremity nerve surgery literature. The references below identify authors and topic areas associated with the historical observational findings summarized on this site.

Dellon AL, et al.

Nerve decompression and protective sensation in diabetic neuropathy

Aszmann OC, et al.

Decompression of lower-extremity nerves in diabetic patients

Valdivia JM, et al.

Surgical decompression and ulcer recurrence outcomes

Upton AR, McComas AJ

The double-crush hypothesis in nerve compression

Observational evidence is identified as observational throughout this site. It is not presented as D.U.R.A. Study results, and it does not establish effectiveness of the procedure.

Referral Process

The study team collaborates with referring clinicians. Patients remain under the primary care of their referring provider throughout enrollment.

1. Referral Submission

Submit a referral via the form below, or contact the study team at info@preventfootulcer.com. Please do not send detailed medical records through the website form.

2. Screening & Feedback

Trial screening and sensory evaluation take place at the Atlanta site. A consultative report is shared with your office.

3. Follow-up

Post-procedure sensory mapping and wound surveillance summaries are shared with your practice per the study protocol.

Refer a Potential Participant

Submit a referral or review detailed study information.

Refer a Potential Participant Review Study Information

Study Coordination Desk

Study Inquiry & Referral Form

I am submitting this inquiry as a: *

First Name *

Last Name *

Email Address *

Phone Number

Preferred Study Site *

Referring Clinic (Optional)

Relevant Context (optional, check all that apply):

History of a healed diabetic foot ulcerDiagnosed with diabetic peripheral neuropathyCurrently has an active open woundIn-person consultation requested

Additional information

Please do not submit medical records or highly sensitive health information through this field. If additional clinical information is needed, the study team will provide instructions during the formal screening process.

I understand this is a research study inquiry, that submitting this form does not determine eligibility or create a doctor–patient relationship, and that final eligibility is decided by the study investigators through clinical evaluation and informed consent. I have reviewed the Privacy Policy and Terms & Conditions.

Information submitted through this website is used by the study team for eligibility screening and study communication under IRB oversight (ClinicalTrials.gov NCT01762085). It is not sold or used for unrelated marketing. Please do not include detailed medical records in this form.