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.
Trial summary
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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
Read more
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Tarek Saad Mohamed, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparative Study of Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT07882238
- Acronym / sponsor ID
- BTX vs Duloxetine for DPN Pain
- Conditions
- Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy, Diabetic Foot Pain, Neuralgia
- Keywords
- Botulinum Toxin Type A, Duloxetine, Perineural Injection, Ultrasound-guided Injection, Nerve Conduction Study, Foot Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B: Perineural Botulinum Toxin Type A | Experimental | Drug: Botulinum Toxin Type A, Other: Oral Placebo TabletParticipants 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). |
| Group D: Oral Duloxetine | Active comparator | Drug: Duloxetine, Other: Sham Perineural InjectionParticipants 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). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type AA 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. | Drug | Group B: Perineural Botulinum Toxin Type A |
| DuloxetineOral 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). | Drug | Group D: Oral Duloxetine |
| Oral Placebo TabletMatching inert oral placebo tablets identical in appearance, packaging, and dosing schedule to duloxetine, taken once daily for 12 weeks. | Other | Group B: Perineural Botulinum Toxin Type A |
| Sham Perineural InjectionSingle-session ultrasound-guided superficial subcutaneous injection of 5 mL 0.9% sterile saline without perineural deposition around the ankle nerves to preserve participant masking. | Other | Group D: Oral Duloxetine |
Primary outcome
Change from Baseline in Foot Pain Intensity on the Visual Analogue Scale (VAS) at 6 Months
Time frame: Baseline and 6 months post-intervention
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Foot Pain Intensity on the Visual Analogue Scale (VAS) at 6 Months (time frame: Baseline and 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.