Diabetic Peripheral Neuropathy (DPN)LVB ease DPNNCT07126197
Using Lymphovenous Bypass to Alleviate Diabetic Peripheral Neuropathy
A study testing lymphovenous bypass at diseased foot dorsum in people with Diabetic Peripheral Neuropathy (DPN) and Diabetic Peripheral Neuropathic Pain (DPNP), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Diabetes is a metabolic disease characterized by high blood sugar levels due to a lack of insulin. Long-term metabolic disorders can cause structural and functional changes in many organs, mainly affecting the vascular system, and leading to complications in the eyes, kidneys, and nervous system. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN), Diabetic Peripheral Neuropathic Pain (DPNP), Diabetic Foot Ulcer
- What is being tested?
- lymphovenous bypass at diseased foot dorsum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 20 to 80 years old.
- Gender: no distinction.
- Patients diagnosed with diabetic peripheral neuropathy, with or without diabetic foot ulcers, but there will be different groups.
- Patients can cooperate with doctors' orders as much as possible.
- Wound care that requires regular wound cleaning and dressing changes by nursing staff.
- Agree to join this study and sign the consent form.
Who cannot join
- Patients with autoimmune diseases, such as systemic lupus erythematosus.
- Patients with organ failure, such as heart, lung, kidney, and liver failure.
- Patients with diabetic foot ulcers and severe infections that require amputation of the forefoot.
- Patients with significant cognitive impairment or insufficient consciousness and unable to understand the purpose of the plan.
- Under 20 years old and over 80 years old.
- Patients receiving palliative care.
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- Pregnant women.
- Patients whose physical condition cannot accept general anesthesia or surgery.
- Patients who are allergic to Patent Blue V or Gentian Violet injection for lymphatic visualization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Diabetes is a metabolic disease characterized by high blood sugar levels due to a lack of insulin. Long-term metabolic disorders can cause structural and functional changes in many organs, mainly affecting the vascular system, and leading to complications in the eyes, kidneys, and nervous system. Diabetic Peripheral Neuropathy (DPN) is a common complication, affecting about 50% of patients. According to the Chinese Diabetes Association, DPN is diagnosed when diabetic patients exhibit signs of peripheral nerve dysfunction, as determined by physical examination or electrophysiological testing, after excluding other causes. The prevalence of DPN in diabetic patients is generally over 30%, with 20-30% experiencing significant pain and mobility issues, severely affecting quality of life and increasing the risk of amputation. Prevention and control rely on strict blood sugar management and lifestyle adjustments, as no medication or surgical intervention can cure DPN.
The lymphatic system plays an immunological role in regulating immune cell migration and inflammatory responses. Supermicrosurgical lymphovenous bypass (LVB) has become a routine treatment for lymphedema, allowing high-pressure lymph fluid to drain into non-occluded deep venous systems, alleviating lymphedema, restoring TH1 and TH2 balance, reducing oxidative stress, and enhancing antioxidant capacity. LVB may delay DPN progression, alleviate pain (DPNP), and promote diabetic foot ulcer healing. In our clinical experience, a patient with Charcot's neuroarthropathy and chronic plantar ulcers underwent LVB alongside wound care. Five years of follow-up showed complete wound healing without further amputation, despite poor HbA1c control. Thus, we aim to further accumulate clinical experience and data, study histological changes, and confirm the benefits of this surgery to help similar patients.
- Conditions
- Diabetic Peripheral Neuropathy (DPN), Diabetic Peripheral Neuropathic Pain (DPNP), Diabetic Foot Ulcer
- Being tested
- lymphovenous bypass at diseased foot dorsum
- Keywords
- lymphaticovenular anastomosis, lymphovenous bypass
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphovenous bypass at diseased foot dorsumProcedure or surgery
A lymphovenous bypass procedure using a lymphangiography dye (Patent Blue V or indocyanine green), 0.2 mL was injected into the skin at the toe webspaces preoperatively. 8,13,14 The paths of lymphatic vessels were traced. On the foot dorsum of the affected limb, a horizontal incision of 2-3 cm was made close to the lymphatic vessel's pathway. Under the surgical microscope, suitable lymphatic and venous vessels were identified, usually located above the deep fascia (on the superficial side, ensuring that the extensor hallucis longus tendon remains unexposed). The coaptation between the lymphatic vessels and venules followed the same principles as those for vascular anastomosis by using higher magnification under the surgical microscope (approximately 20×), finer microsurgical instruments, and 11- or 12-0 nylon sutures.
| Study group | Role | What they receive |
|---|---|---|
| Patients having DPN(P) with/without DFUs undergo lymphovenous bypass | Experimental | Patients having DPN(P) with/without DFUs undergo lymphovenous bypass and biopsy at foot dorsum. DPN n = 10, DPNP n = 10, DFU n = 20 Receives: Procedure: lymphovenous bypass at diseased foot dorsum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sudoscan
Sudoscan is a non-invasive medical device that assesses sweat gland function, specifically measuring sweat chloride concentrations in the palms and soles. This provides an indirect measure of small fiber neuropathy, as these nerve fibers innervate the sweat glands. The test involves placing a patient's hands and feet on electrodes, and a low-voltage electrical current is passed through the skin. The device then calculates electrochemical skin conductance (ESC). Abnormal ESC values can indicate autonomic neuropathy, a common complication of conditions like diabetes, affecting nerves responsible for involuntary bodily functions.
Measured: Preoperative, Postoperative 6 and 12 months
Heart Rate Variability (HRV)
HRV measures the variation in time between consecutive heartbeats. It reflects the balance and responsiveness of the autonomic nervous system, specifically the sympathetic ("fight or flight") and parasympathetic ("rest and digest") branches. A higher HRV generally indicates a more flexible and adaptable nervous system, associated with better health and stress resilience. A lower HRV can signal chronic stress, fatigue, or underlying health issues. It is a non-invasive tool used to assess cardiovascular health and monitor recovery.
Measured: Preoperative, Postoperative 6 and 12 months
Quantitative Sensory Testing (QST)
QST is a non-invasive method for assessing the function of sensory nerve fibers. It measures a person's ability to feel and respond to various stimuli, such as temperature (cold and warm detection thresholds) and vibration. By applying controlled stimuli and recording the patient's perception, clinicians can identify and quantify sensory deficits. QST helps diagnose and monitor conditions affecting the peripheral nervous system, such as diabetic neuropathy, and can be used to track disease progression or the effectiveness of treatments.
Measured: Preoperative, Postoperative 6 and 12 months
Michigan Neuropathy Screening Instrument (MNSI)
The MNSI is a two-part tool for screening for diabetic peripheral neuropathy. The first part is a 15-item patient questionnaire that asks about common neuropathic symptoms like numbness, burning pain, and muscle cramps. The second part is a physical examination conducted by a healthcare professional. This exam includes a visual inspection of the feet for deformities or ulcers, an assessment of ankle reflexes, and a crucial test of vibratory sensation using a tuning fork. The MNSI provides a quick, cost-effective way to identify patients who may need further diagnostic evaluation for neuropathy.
Measured: Preoperative, Postoperative 6 and 12 months
DN4 (Douleur Neuropathique en 4 Questions)
The DN4 is a questionnaire specifically designed to identify neuropathic pain, which is a common and often debilitating symptom of diabetic neuropathy. It consists of 10 questions divided into two sections. The first part involves interviewing the patient about their pain characteristics, asking if they experience sensations like burning, cold, electric shocks, tingling, or numbness. The second part is a brief physical examination where the clinician checks for reduced sensation to touch or pinprick and if light brushing causes pain. A score of 4 or more out of 10 suggests the presence of neuropathic pain.
Measured: Preoperative, Postoperative 6 and 12 months
Intra-Epidermal Nerve Fiber (IENF) density
IENF density is a quantitative measure used to assess the health of small nerve fibers. It is determined by counting the number of nerve fibers within a specific length of the epidermis, typically from a small skin biopsy. A reduction in IENF density is a key marker of small fiber neuropathy, an early sign of conditions like diabetic neuropathy. Because these fibers are among the first to be damaged, measuring IENF density is considered a highly sensitive and objective method for diagnosing and monitoring the progression of the disease.
Measured: Preoperative and Postoperative 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start11 Feb 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The protocol begins with patient recruitment from two clinics, followed by a joint DM co-care evaluation. Eligible patients who consent undergo baseline data collection, including demographics, lab work, and neuropathy tests (Sudoscan, HRV, QST, MNSI, DN4). Participants allocated to DPN, DPNP, and DFU subgroups will undergo a key step involves a lymphovenous bypass surgery (with/without) and a biopsy to assess Intra-Epidermal Nerve Fiber (IENF) density. The study includes follow-up visits at 6 and 12 months for repeated neuropathy evaluations. Another skin biopsy for IENF density is also performed at the 12-month check-up. The final stage involves a comparative analysis of the data collected from all groups to assess outcomes. Exclusion criteria include patients with amputations, specific drug prescriptions, and severe peripheral artery disease (ABI ≤ 0.9).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126197
- Sponsor's protocol ID
- 202503048RINA
- Other IDs
- 114-R0011
- Acronym
- LVB ease DPN
- Status last verified
- Feb 2026
- First submitted
- 10 Aug 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee HY, Wang CY, Chang TJ, Chao CC, Hsieh ST, Cheng NC, Chao SC. Lymphovenous Bypass as an Adjunct to Standard Care for Diabetic Peripheral Neuropathy: Protocol for a Randomized Assessor-Blinded Superiority Trial. JMIR Res Protoc. 2026 Jun 8;15:e84826. doi: 10.2196/84826.
PubMed 42258610
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Lymphovenous Bypass to Alleviate Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07126197
- Acronym / sponsor ID
- LVB ease DPN / 202503048RINA
- Conditions
- Diabetic Peripheral Neuropathy (DPN), Diabetic Peripheral Neuropathic Pain (DPNP), Diabetic Foot Ulcer
- Keywords
- lymphaticovenular anastomosis, lymphovenous bypass
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Aug 2025 (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.
Diabetes is a metabolic disease characterized by high blood sugar levels due to a lack of insulin. Long-term metabolic disorders can cause structural and functional changes in many organs, mainly affecting the vascular system, and leading to complications in the eyes, kidneys, and nervous system. Diabetic Peripheral Neuropathy (DPN) is a common complication, affecting about 50% of patients. According to the Chinese Diabetes Association, DPN is diagnosed when diabetic patients exhibit signs of peripheral nerve dysfunction, as determined by physical examination or electrophysiological testing, after excluding other causes. The prevalence of DPN in diabetic patients is generally over 30%, with 20-30% experiencing significant pain and mobility issues, severely affecting quality of life and increasing the risk of amputation. Prevention and control rely on strict blood sugar management and lifestyle adjustments, as no medication or surgical intervention can cure DPN.
The lymphatic system plays an immunological role in regulating immune cell migration and inflammatory responses. Supermicrosurgical lymphovenous bypass (LVB) has become a routine treatment for lymphedema, allowing high-pressure lymph fluid to drain into non-occluded deep venous systems, alleviating lymphedema, restoring TH1 and TH2 balance, reducing oxidative stress, and enhancing antioxidant capacity. LVB may delay DPN progression, alleviate pain (DPNP), and promote diabetic foot ulcer healing. In our clinical experience, a patient with Charcot's neuroarthropathy and chronic plantar ulcers underwent LVB alongside wound care. Five years of follow-up showed complete wound healing without further amputation, despite poor HbA1c control. Thus, we aim to further accumulate clinical experience and data, study histological changes, and confirm the benefits of this surgery to help similar patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The protocol begins with patient recruitment from two clinics, followed by a joint DM co-care evaluation. Eligible patients who consent undergo baseline data collection, including demographics, lab work, and neuropathy tests (Sudoscan, HRV, QST, MNSI, DN4). Participants allocated to DPN, DPNP, and DFU subgroups will undergo a key step involves a lymphovenous bypass surgery (with/without) and a biopsy to assess Intra-Epidermal Nerve Fiber (IENF) density. The study includes follow-up visits at 6 and 12 months for repeated neuropathy evaluations. Another skin biopsy for IENF density is also performed at the 12-month check-up. The final stage involves a comparative analysis of the data collected from all groups to assess outcomes. Exclusion criteria include patients with amputations, specific drug prescriptions, and severe peripheral artery disease (ABI ≤ 0.9).
| Arm | Type | Receives |
|---|---|---|
| Patients having DPN(P) with/without DFUs undergo lymphovenous bypass | Experimental | Procedure: lymphovenous bypass at diseased foot dorsumPatients having DPN(P) with/without DFUs undergo lymphovenous bypass and biopsy at foot dorsum. DPN n = 10, DPNP n = 10, DFU n = 20 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 20 to 80 years old.
- Gender: no distinction.
- Patients diagnosed with diabetic peripheral neuropathy, with or without diabetic foot ulcers, but there will be different groups.
- Patients can cooperate with doctors' orders as much as possible.
- Wound care that requires regular wound cleaning and dressing changes by nursing staff.
Key exclusion criteria (9 listed)
- Patients with autoimmune diseases, such as systemic lupus erythematosus.
- Patients with organ failure, such as heart, lung, kidney, and liver failure.
- Patients with diabetic foot ulcers and severe infections that require amputation of the forefoot.
- Patients with significant cognitive impairment or insufficient consciousness and unable to understand the purpose of the plan.
- Under 20 years old and over 80 years old.
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 |
|---|---|---|
| lymphovenous bypass at diseased foot dorsumA lymphovenous bypass procedure using a lymphangiography dye (Patent Blue V or indocyanine green), 0.2 mL was injected into the skin at the toe webspaces preoperatively. 8,13,14 The paths of lymphatic vessels were traced. On the foot dorsum of the affected limb, a horizontal incision of 2-3 cm was made close to the lymphatic vessel's pathway. Under the surgical microscope, suitable lymphatic and venous vessels were identified, usually located above the deep fascia (on the superficial side, ensuring that the extensor hallucis longus tendon remains unexposed). The coaptation between the lymphatic vessels and venules followed the same principles as those for vascular anastomosis by using higher magnification under the surgical microscope (approximately 20×), finer microsurgical instruments, and 11- or 12-0 nylon sutures. | Procedure or surgery | Patients having DPN(P) with/without DFUs undergo lymphovenous bypass |
Primary outcome
Sudoscan
Time frame: Preoperative, Postoperative 6 and 12 months
Sudoscan is a non-invasive medical device that assesses sweat gland function, specifically measuring sweat chloride concentrations in the palms and soles. This provides an indirect measure of small fiber neuropathy, as these nerve fibers innervate the sweat glands. The test involves placing a patient's hands and feet on electrodes, and a low-voltage electrical current is passed through the skin. The device then calculates electrochemical skin conductance (ESC). Abnormal ESC values can indicate autonomic neuropathy, a common complication of conditions like diabetes, affecting nerves responsible for involuntary bodily functions.
Heart Rate Variability (HRV)
Time frame: Preoperative, Postoperative 6 and 12 months
HRV measures the variation in time between consecutive heartbeats. It reflects the balance and responsiveness of the autonomic nervous system, specifically the sympathetic ("fight or flight") and parasympathetic ("rest and digest") branches. A higher HRV generally indicates a more flexible and adaptable nervous system, associated with better health and stress resilience. A lower HRV can signal chronic stress, fatigue, or underlying health issues. It is a non-invasive tool used to assess cardiovascular health and monitor recovery.
Quantitative Sensory Testing (QST)
Time frame: Preoperative, Postoperative 6 and 12 months
QST is a non-invasive method for assessing the function of sensory nerve fibers. It measures a person's ability to feel and respond to various stimuli, such as temperature (cold and warm detection thresholds) and vibration. By applying controlled stimuli and recording the patient's perception, clinicians can identify and quantify sensory deficits. QST helps diagnose and monitor conditions affecting the peripheral nervous system, such as diabetic neuropathy, and can be used to track disease progression or the effectiveness of treatments.
Michigan Neuropathy Screening Instrument (MNSI)
Time frame: Preoperative, Postoperative 6 and 12 months
The MNSI is a two-part tool for screening for diabetic peripheral neuropathy. The first part is a 15-item patient questionnaire that asks about common neuropathic symptoms like numbness, burning pain, and muscle cramps. The second part is a physical examination conducted by a healthcare professional. This exam includes a visual inspection of the feet for deformities or ulcers, an assessment of ankle reflexes, and a crucial test of vibratory sensation using a tuning fork. The MNSI provides a quick, cost-effective way to identify patients who may need further diagnostic evaluation for neuropathy.
DN4 (Douleur Neuropathique en 4 Questions)
Time frame: Preoperative, Postoperative 6 and 12 months
The DN4 is a questionnaire specifically designed to identify neuropathic pain, which is a common and often debilitating symptom of diabetic neuropathy. It consists of 10 questions divided into two sections. The first part involves interviewing the patient about their pain characteristics, asking if they experience sensations like burning, cold, electric shocks, tingling, or numbness. The second part is a brief physical examination where the clinician checks for reduced sensation to touch or pinprick and if light brushing causes pain. A score of 4 or more out of 10 suggests the presence of neuropathic pain.
Intra-Epidermal Nerve Fiber (IENF) density
Time frame: Preoperative and Postoperative 12 months
IENF density is a quantitative measure used to assess the health of small nerve fibers. It is determined by counting the number of nerve fibers within a specific length of the epidermis, typically from a small skin biopsy. A reduction in IENF density is a key marker of small fiber neuropathy, an early sign of conditions like diabetic neuropathy. Because these fibers are among the first to be damaged, measuring IENF density is considered a highly sensitive and objective method for diagnosing and monitoring the progression of the disease.
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 13 Feb 2026.
- Derived from this study: PubMed 42258610Lee HY, Wang CY, Chang TJ, Chao CC, Hsieh ST, Cheng NC, Chao SC. Lymphovenous Bypass as an Adjunct to Standard Care for Diabetic Peripheral Neuropathy: Protocol for a Randomized Assessor-Blinded Superiority Trial. JMIR Res Protoc. 2026 Jun 8;15:e84826. doi: 10.2196/84826.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lymphovenous bypass at diseased foot dorsum in people with Diabetic Peripheral Neuropathy (DPN) and Diabetic Peripheral Neuropathic Pain (DPNP), run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 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: enrolling by invitation, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Sudoscan (time frame: Preoperative, Postoperative 6 and 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07126197, which also lists 1 linked publication.
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 13 Feb 2026.