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Enrolling by invitation NCT07126197

Using Lymphovenous Bypass to Alleviate Diabetic Peripheral Neuropathy

No phase Interventional Diabetic Peripheral Neuropathy (DPN) Diabetic Peripheral Neuropathic Pain (DPNP) Diabetic Foot Ulcer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: lymphovenous bypass at diseased foot dorsum.
Who it may be relevant to
Registry conditions: Diabetic Peripheral Neuropathy (DPN), Diabetic Peripheral Neuropathic Pain (DPNP), Diabetic Foot Ulcer. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure 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, ensur

Primary outcome measures

  • Sudoscan [Time frame: Preoperative, Postoperative 6 and 12 months]
  • Heart Rate Variability (HRV) [Time frame: Preoperative, Postoperative 6 and 12 months]
  • Quantitative Sensory Testing (QST) [Time frame: Preoperative, Postoperative 6 and 12 months]
  • Michigan Neuropathy Screening Instrument (MNSI) [Time frame: Preoperative, Postoperative 6 and 12 months]
  • DN4 (Douleur Neuropathique en 4 Questions) [Time frame: Preoperative, Postoperative 6 and 12 months]
  • Intra-Epidermal Nerve Fiber (IENF) density [Time frame: Preoperative and Postoperative 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT07126197 · 202503048RINA · 114-R0011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗