A Phase 2 interventional study of Botulinum Toxin Type A and Duloxetine in Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy and Diabetic Foot Pain, sponsored by Assiut University. Not yet recruiting. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Assiut University · Phase 2, Interventional, and Treatment
Painful diabetic peripheral neuropathy (DPN) is a frequent and disabling complication of diabetes that commonly causes persistent foot pain, sleep impairment, and decreased quality of life. While oral medications such as duloxetine are established treatment options, many patients experience incomplete pain control or encounter dose-limiting side effects. Perineural botulinum toxin type A (BTX-A) injection has emerged as an interventional approach designed to inhibit peripheral pain signaling with targeted, prolonged local effect.
The purpose of this study is to compare the efficacy and safety of a single session of ultrasound-guided perineural BTX-A injection versus standard daily oral duloxetine therapy in relieving foot pain in patients with painful diabetic peripheral neuropathy.
Participants will be randomly assigned to one of two groups using a double-dummy design to preserve blinding:
Participants will be followed for 6 months to evaluate changes in foot pain intensity on the Visual Analogue Scale (VAS) at 1 week, 1 month, 3 months, and 6 months. The study will also assess objective peripheral nerve function through bilateral nerve conduction studies (NCS) at baseline and 6 months, alongside evaluations of neuropathic pain scores, sleep quality, quality of life, and adverse effects.
629 studies on the registry are indexed under Diabetic Neuropathies; 92 are open to participants now.
This study's planned enrollment of 56 is below the median of 72 across 522 interventional studies indexed under Diabetic Neuropathies.
Browse Diabetic Neuropathies studies →Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Participants receive a single session of ultrasound-guided perineural injection of botulinum toxin type A (total dose 100 units reconstituted in 5 mL of preservative-free 0.9% saline) distributed around ankle nerves (posterior tibial, superficial peroneal, deep peroneal, sural, and saphenous nerves) of the affected lower limb. In addition, participants receive matching oral placebo tablets identical in appearance to duloxetine, taken once daily for 12 weeks (double-dummy design).
Drug: Botulinum Toxin Type A · Other: Oral Placebo Tablet
Participants receive a single session of ultrasound-guided sham perineural injection (subcutaneous 0.9% saline without perineural deposition) to the affected lower limb. In addition, participants take active oral duloxetine: 30 mg once daily for the first week, escalated to 60 mg once daily for the subsequent 11 weeks (12 weeks total course; double-dummy design).
Drug: Duloxetine · Other: Sham Perineural Injection
A single session of ultrasound-guided perineural injection of botulinum toxin type A (total dose 100 units reconstituted in 5 mL preservative-free 0.9% normal saline) administered around the ankle nerves (posterior tibial, superficial peroneal, deep peroneal, sural, and saphenous nerves) of the affected lower limb.
Oral duloxetine administered once daily for a total of 12 weeks: initiated at 30 mg once daily for the first week (Week 1), then escalated to 60 mg once daily for the remaining 11 weeks (Weeks 2-12).
Matching inert oral placebo tablets identical in appearance, packaging, and dosing schedule to duloxetine, taken once daily for 12 weeks.
Single-session ultrasound-guided superficial subcutaneous injection of 5 mL 0.9% sterile saline without perineural deposition around the ankle nerves to preserve participant masking.
Change from Baseline in Foot Pain Intensity on the Visual Analogue Scale (VAS) at 6 Months
Foot pain intensity is assessed using the Visual Analogue Scale (VAS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). The score is calculated as the change from pre-intervention baseline to the 6-month follow-up visit. A negative change indicates pain reduction (clinical improvement).
Time frame: Baseline and 6 months post-intervention
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 34 phase 2 interventional studies under Diabetic Neuropathies, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's planned 12 months is below that.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A