Using Lymphovenous Bypass to Alleviate Diabetic Peripheral Neuropathy

NCT ID: NCT07126197

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-11
• Study Completion Date: 2026-12-31

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients having DPN(P) with/without DFUs undergo lymphovenous bypass

Patients having DPN(P) with/without DFUs undergo lymphovenous bypass and biopsy at foot dorsum. DPN n = 10, DPNP n = 10, DFU n = 20

Group Type: EXPERIMENTAL

lymphovenous bypass at diseased foot dorsum

Intervention Type: PROCEDURE

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.

Interventions

lymphovenous bypass at diseased foot dorsum

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

114-R0011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

202503048RINA

Identifier Type: -

Identifier Source: org_study_id