Diabetic Peripheral NeuropathyPhase 2NCT07882238

Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy

A Phase 2 study testing Botulinum Toxin Type A and Duloxetine in people with Diabetic Peripheral Neuropathy and Painful Diabetic Neuropathy, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 30 to 70 years
Conditions the study is for: Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy, Diabetic Foot Pain
What is being tested?: Botulinum Toxin Type A and Duloxetine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: No sites listed yet
Study dates: Nov 2026to Dec 2027
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Confirmed diagnosis of diabetes mellitus.
Clinically diagnosed painful diabetic peripheral neuropathy of the foot (Douleur Neuropathique en 4 questions [DN4] score ≥ 4) confirmed electrophysiologically by nerve conduction study.
Baseline foot pain Visual Analogue Scale (VAS) score ≥ 4 despite receiving non-SNRI first-line oral therapy (e.g., a gabapentinoid) for at least 4 weeks.
Duloxetine-naïve at the time of enrollment.

Who cannot join

Peripheral neuropathy attributable to causes other than diabetes (e.g., vitamin B12 deficiency, hypothyroidism, alcohol-related, uremic, hereditary, or chemotherapy-induced neuropathy).
Known hypersensitivity to botulinum toxin, duloxetine, or other serotonin-norepinephrine reuptake inhibitors (SNRIs).
Local skin infection, active ulceration, or severe peripheral vascular disease at the intended injection site.
Coagulopathy or current anticoagulant/antiplatelet therapy that cannot be safely interrupted.
Pre-existing neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome).
Current or recent (within 14 days) use of monoamine oxidase inhibitors (MAOIs), or concurrent use of other serotonergic agents.

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Significant hepatic impairment, uncontrolled narrow-angle glaucoma, or uncontrolled hypertension.
Pregnancy or lactation.
Poorly controlled psychiatric illness or cognitive impairment precluding reliable reporting of pain and outcome measures.

About this study

Official title: Randomized Comparative Study of Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy

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:

Group B (Botulinum Toxin): Receives a single session of ultrasound-guided perineural botulinum toxin type A injection around the ankle nerves plus daily oral placebo tablets for 12 weeks.
Group D (Duloxetine): Receives a single session of sham subcutaneous injection plus oral duloxetine tablets daily for 12 weeks (30 mg once daily for week 1, increased to 60 mg once daily for weeks 2-12).

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.

Conditions: Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy, Diabetic Foot Pain, Neuralgia
Being tested: Botulinum Toxin Type A, Duloxetine, Oral Placebo Tablet, Sham Perineural Injection
Keywords: Botulinum Toxin Type A, Duloxetine, Perineural Injection, Ultrasound-guided Injection, Nerve Conduction Study, Foot Pain
Medical subject headings: Diabetic Neuropathies, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Botulinum Toxin Type ADrug
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.
DuloxetineDrug
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).
Oral Placebo TabletOther
Matching inert oral placebo tablets identical in appearance, packaging, and dosing schedule to duloxetine, taken once daily for 12 weeks.
Sham Perineural InjectionOther
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.

Study groups in NCT07882238
Study group	Role	What they receive
Group B: Perineural Botulinum Toxin Type A	Experimental	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). Receives: Drug: Botulinum Toxin Type A; Other: Oral Placebo Tablet
Group D: Oral Duloxetine	Active comparator	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). Receives: Drug: Duloxetine; Other: Sham Perineural Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline and 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2026Dec 2027

First posted20 Oct 2026
Study startNov 2026 (estimated)
Primary completionNov 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
More trials run by Assiut UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 56 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07882238
Sponsor's protocol ID: BTX vs Duloxetine for DPN Pain
Status last verified: Oct 2026
First submitted: 13 Oct 2026
Last updated: 20 Oct 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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