Can We Actually “Regrow” Sensation? The Launch of PDN-Sensory #DiabeticFoot #Neuromodulation #ActAgainstAmputation #Neuropathy

For years, we’ve treated Painful Diabetic Neuropathy (PDN) largely by trying to turn down the volume on the pain. While relief is critical, the “holy grail” has always been something more: stopping the damage or, dare we dream, reversing it.

We have just published the design for a new multicenter randomized controlled trial (RCT) in BMJ Open that asks an important question: Can high-frequency 10 kHz spinal cord stimulation (SCS) actually improve neurological function?

The Context: Moving Beyond the “Ouch” and Regifting the “Gift of Pain”

In the recent SENZA-PDN study, we saw that 10 kHz SCS didn’t just significantly reduce pain; it appeared to improve sensory function in over half of the patients. That was a surprising signal, but we needed to test it rigorously. Why is this happening? Is it (as I have said before) acting like a pair of “noise cancelling headphones” for pain signal, thereby causing people to feel more when the background nociceptive noise is removed? Is there something else? This question remains unclear.

The PDN-Sensory Study

This new trial, dubbed PDN-Sensory, is designed to provide more objective evidence. We are randomizing patients to receive either Conventional Medical Management (CMM) alone or 10 kHz SCS plus CMM4.

Here is what makes this study different: We are looking under the microscope.

• The Biopsies: We are using skin biopsies to measure intraepidermal nerve fiber density (IENFD). This is the gold standard for diagnosing small fiber neuropathy. We aren’t just asking patients how they feel; we are counting the nerve fibers to see if they are regenerating
• The Neurological Score: We are using the modified Toronto Clinical Neuropathy Score (mTCNS) to track changes in numbness, tingling, and reflexes
• The Goal: The primary endpoint is greater than 50% pain relief, but the key secondary endpoint is neurological improvement.

Why This Matters

If 10 kHz SCS can restore sensation—what we call a “disease-modifying effect”—we aren’t just treating symptoms. We are potentially reducing the risk of falls, ulcers, and amputations associated with the “loss of gift of pain”.

This is the first RCT in the field to use these objective neurological endpoints as criteria for success. We are excited to see where the data leads us.

Reference: Pop-Busui R, Petersen EA, Levy BL, Tesfaye S, Armstrong DG, Grunberger G, Boulton AJM, Bharara M, Edgar D, Azalde RP, Caraway D.Evaluating pain and neurological function with high frequency 10 kHz spinal cord stimulation in the treatment of painful diabetic neuropathy: design of a multicentre, randomised controlled trial (PDN-Sensory). BMJ Open 2025;15:101647.