Understanding the D.U.R.A. Study
This page explains, in plain language, what recurrent diabetic foot ulcers are, what nerve decompression is, and what the D.U.R.A. Study is evaluating. The D.U.R.A. Study is research, not regular medical treatment.
Who May Qualify?
The study's general parameters include adults with diabetes who have had a healed diabetic foot ulcer and who experience neuropathy symptoms. This is only a general description. Final eligibility is determined by the study investigators through clinical evaluation and informed consent.
Does the D.U.R.A. Study Sound Like It May Apply to You?
Answer 5 questions to see if your situation aligns with the study's general parameters.
Has a doctor diagnosed you with Type 1 or Type 2 diabetes?
The D.U.R.A. Study is evaluating nerve compression associated with diabetic neuropathy.
Have you previously had a diabetic foot ulcer that has fully or substantially healed?
This trial focuses on prevention of recurrence after an ulcer has closed, rather than acute wound treatment.
Do you experience numbness, tingling, burning, or loss of protective feeling in your feet or toes?
These symptoms may be associated with diabetic peripheral neuropathy. Additional clinical evaluation and testing are required to determine whether nerve compression may also be present.
Are your feet currently free from active bone infection (osteomyelitis) or emergency tissue infection?
Active untreated infections require immediate wound or hospital care before any elective research procedure can be considered.
Are you able to travel for evaluation at our Atlanta, GA site (or a future South Florida site)?
Participants attend in-person consultations, diagnostic evaluations, and periodic follow-up visits.
Please answer all 5 questions to view preliminary alignment.
What Is D.U.R.A. Studying?
The D.U.R.A. Study is an IRB-approved clinical trial evaluating whether an outpatient nerve-decompression procedure may improve protective sensation and reduce the recurrence of diabetic foot ulcers in appropriately selected patients. It is sponsored by the Association of Extremity Nerve Surgeons (AENS) and registered as ClinicalTrials.gov NCT01762085.
Previous observational studies have reported lower ulcer-recurrence rates following nerve decompression, but these studies have limitations and do not establish effectiveness. The D.U.R.A. Study is evaluating this question prospectively.
Understanding Recurrent Diabetic Foot Ulcers
A diabetic foot ulcer is an open sore on the foot that can develop when diabetes causes nerve damage and reduced feeling. Even after an ulcer heals, the underlying nerve damage often remains — and many people develop another ulcer in the same area. This is called recurrence. The D.U.R.A. Study is focused on this problem: finding ways to help prevent ulcers from coming back after they have healed.
What Is Diabetic Neuropathy?
Diabetic neuropathy is nerve damage caused by diabetes. Over time, high blood sugar can damage peripheral nerves — the nerves in the legs and feet — and reduce protective sensation. When you cannot feel pressure, rubbing, or a small injury, a sore can form and go unnoticed until it becomes serious.
In some patients, researchers believe nerve compression at anatomical tunnels in the leg and foot may contribute additional nerve dysfunction. The D.U.R.A. Study is evaluating whether relieving this compression may help.
What Is Nerve Decompression?
Nerve decompression is an outpatient surgical procedure intended to relieve mechanical pressure on nerves at specific anatomical tunnels in the lower leg and foot. By releasing tight fibrous bands around these nerves, the procedure is intended to reduce compression.
Important: Nerve decompression is surgery and carries surgical risks. It does not guarantee improved sensation or ulcer prevention for any individual. The D.U.R.A. Study is evaluating whether it may help reduce recurrence.
What Does Participation Involve?
Initial Screening
A phone conversation with a study coordinator to review your diabetes history, ulcer healing, and symptoms.
Diagnostic Evaluation
An in-person evaluation at the Atlanta site (US Neuropathy Centers) to assess possible nerve entrapment using sensory testing.
Your Decision
You receive full informed consent materials. You decide whether to take part — and you may withdraw at any time, for any reason, without penalty to your care.
Potential Risks & Potential Benefits
The D.U.R.A. Study is a research study, not standard medical treatment. The nerve-decompression procedure may reduce recurrence risk for some people, but it is surgery and individual results cannot be guaranteed.
Potential Benefits
- May help improve protective sensation in the feet.
- May reduce the chance of another ulcer forming.
- Helps researchers learn how to better protect feet long-term.
Potential Risks
- Surgical risks: infection, bleeding, poor wound healing.
- Anesthesia risks for outpatient surgery.
- Possible nerve injury or no improvement in sensation.
- The procedure may not prevent another ulcer for everyone.
A complete list of risks and benefits will be reviewed with you during the informed consent process before any decision is made. Participation is always voluntary, and you may withdraw at any time without affecting your regular medical care.
Frequently Asked Questions
Is the D.U.R.A. Study a treatment for my foot ulcer?
Does the procedure guarantee my ulcer won't come back?
Is there a cost for study screening?
Can I leave the study after I join?
Have Questions About the Study?
A study coordinator is available to answer questions for patients and family caregivers.