Study Protocol & Science
ClinicalTrials.gov Identifier NCT01762085. Sponsored by the Association of Extremity Nerve Surgeons (AENS), the D.U.R.A. Study is evaluating whether lower-extremity nerve decompression may reduce recurrent diabetic foot ulceration in appropriately selected patients.
Why This Study Is Being Conducted
Why This Study Is Being Conducted
Previous observational studies have reported lower ulcer-recurrence rates following nerve decompression in selected patients. However, these studies have important limitations and do not establish that nerve decompression prevents recurrent ulcers. The D.U.R.A. Study is evaluating this question prospectively under IRB-approved conditions.
Standard Wound Care Alone
Offloading, diabetic footwear, local wound care & glycemic monitoring
Approximately 1 in 3 to 4 healed-ulcer patients experiences recurrent breakdown within 12 months.
Standard Care + Nerve Decompression
Surgical release of entrapped lower-extremity nerves
Lower re-ulceration was observed in selected surgical cohorts.
How to read this: These figures are drawn from previously published case series and historical control cohorts — not from a head-to-head randomized trial, and not from The D.U.R.A. Study. Observational findings do not establish effectiveness. Individual results cannot be predicted, and the procedure carries surgical risks.
*Recurrence figures reflect published extremity nerve surgery literature (e.g., Dellon AL, Aszmann OC, et al.) and historical controls. They are not outcomes of The D.U.R.A. Study, which remains enrolling. Final results will be reported upon study completion.
Nerve Decompression Sites
Lower-extremity nerve decompression focuses on anatomical fibro-osseous tunnels where nerve compression is proposed to contribute to dysfunction.
Tarsal Tunnel & Plantar Tunnels
Medial Malleolus & Abductor Hallucis
Release of the flexor retinaculum and plantar tunnels. This area provides sensation to the plantar weight-bearing surface where ulcers typically form.
Common Peroneal Nerve
Fibular Neck & Peroneus Longus
Decompression at the lateral knee where the nerve crosses the fibular neck through the peroneus longus fascia.
Deep Peroneal Nerve
Dorsum of Foot / First Web Space
Release of the deep peroneal nerve beneath the inferior extensor retinaculum, associated with the first intermetatarsal space.
Study Design & Follow-up
Sensory Mapping
Candidates undergo neurosensory testing, which may include Semmes-Weinstein monofilament mapping, two-point discrimination, and Tinel sign localization.
Post-procedure follow-up intervals are scheduled to measure sensory outcomes and cutaneous integrity over the study period.
Endpoints
The primary outcome measures recurrent ulceration over the study period, compared against historical control cohorts receiving standard offloading footwear and routine care. This is a comparison to historical data, not a concurrent randomized control arm.
Secondary endpoints evaluate neuropathic symptoms and related outcomes.
Specific follow-up intervals, endpoint definitions, and study design details should be confirmed against the ClinicalTrials.gov record and the study protocol.
Published Evidence & References
Historical recurrence figures cited on this site (e.g., 20–40% standard care; 4.8% in prior observational studies) are drawn from published extremity nerve surgery literature.
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
The D.U.R.A. Study is an IRB-approved clinical research trial registered with ClinicalTrials.gov under Identifier NCT01762085, sponsored by the Association of Extremity Nerve Surgeons (AENS). Participation is voluntary. Individual outcomes cannot be predicted or guaranteed.
Interested in Referring or Inquiring?
The study coordination desk can answer questions about the protocol.