Lymphovenous Bypass Manage Venous Leg Ulcers

Study Overview
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Brief Summary
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Leg ulcers are areas of epidermal discontinuity in lower limbs with causes of venous, arterial, diabetic, pressure, traumatic, allergic, or inflammation. Chronic venous leg ulcers (VLUs) are defined as leg ulcers persisting for 4 weeks or more, a.k.a C6 in CEAP classification of chronic venous insufficiency (CVI) and account for up to 70% of all chronic leg ulcers exhibiting overall prevalence of up to 2% in the general population of western countries with significant morbidity and a negative socioeconomic impact. Wound care, debridement, bed rest with leg elevation, and compression are basic approaches for chronic VLUs. Meanwhile, numerous medical and surgical interventions were developed to promote wound healing and to prevent recurrence by focusing on pathophysiology of chronic VLUs. However, many strategies just have adjuvant effects or exert debatable benefits. The lymphatic system been considered important for removal of excessive fluid from the interstitial space, absorption of fat from the intestine and the immune system, actively involved in regulation of immune cell trafficking and inflammation. Emerging lymphovenous bypass (LVB), a supermicrosurgical technique diverting lymphatic drainage into venous system in dealing with lymphedema, not only restores TH1 and TH2 imbalance, but decreases oxidative stress and increases antioxidant capacity in the serum of lymphedema patients. Clinically, LVB could be an alternative treatment option for patients with lymphorrhea. Based on these facts, the investigators hypothesis that lymphatic hypertension and lymph impregnation contributes chronic venous leg ulcer formation and propose a novel strategy, using LVB to treat patients with refractory/recurrent chronic VLUs. The preliminary results revealed promising results and the investigators would go on clinical trials.

Official Title
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Lymphovenous Bypass (LVB) Promotes Healing Process of Venous Leg Ulcers

Conditions
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Venous Leg Ulcer, Lymphovenous Edema

Intervention / Treatment
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* Procedure: Lymphovenous bypass, including lymphaticovenular anastomosis/implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 20 80 years Gender: All Poor wound healing after standard wound management for 4 weeks Deep vein thrombosis (DVT) has been ruled out by Duplex and Computer tomography or DVT has been treated Wound care with nursing specialty Recognize and agree to join this trial Exclusion Criteria: Autoimmune status, such as systemic lupus erythematosus Heart, lung, kidney or liver failure patients Radiation related wound or cancer wound Those who cannot understand the trial Age less than 20 years or elder than 80 years Pregnancy Those who was Risky to receive general anesthesia or surgery Allergy to Patent Blue V or Gentian Violet

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venous leg ulcers patients undergoing lymphovenous bypass<br> | Procedure: Lymphovenous bypass, including lymphaticovenular anastomosis/implantation<br>* Lymphovenous bypass (LVB) is a supermicrosurgical technique by diverting lymphatic drainage into venous system. Simultaneously, we performed LVB at ipsilateral foot dorsum and debride the VLUs and resurface the wound primarily or by skin graft depending on defect size.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing process of venous leg ulcers | Clinical assessment of wound healing in surface area (centimeter square) | Postoperative 4 8 weeks | 
| Healing process of venous leg ulcers | Clinical assessment of wound healing in surface area (centimeter square) | Postoperative 12 weeks | 
| Healing process of venous leg ulcers | Clinical assessment of wound healing in surface area (centimeter square) | Postoperative 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The venous leg ulcer quality of life (VLU-QoL) questionnaire (Chinese version verified), 0 (minimum)   100 (maximum), higher scores mean a worse outcome | The questionnaire evaluates 3 dimesions including activities, psychological and symptom distress aspect of patient having venous leg ulcers. | Preoperative | 
| The venous leg ulcer quality of life (VLU-QoL) questionnaire (Chinese version verified), 0 (minimum)   100 (maximum), higher scores mean a worse outcome | The questionnaire evaluates 3 dimesions including activities, psychological and symptom distress aspect of patient having venous leg ulcers. | Postoperative 12 weeks | 
| Venous Clinical Severity Score (VCSS), 0 (minimum)   30 (maximum), higher scores mean a worse outcome | Scoring system of chronic venous insufficiency | Postoperative 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Venous Insufficiency, Lymphovenous Bypass