Lymphovenous Bypass Manage Venous Leg Ulcers

Venous Leg Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05068258
• Other study ID #: 202105094RIND
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: October 1, 2028

Study information

• Verified date: March 2023
• Source: National Taiwan University Hospital
• Contact: Sung-Chuan Chao, MD, PhD
• Phone: +886-2312-3456
• Email: chao1977[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2028
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Procedure:
• Lymphovenous bypass, including lymphaticovenular anastomosis/implantation
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.

Locations

Country	Name	City	State
Taiwan	Sung-Chuan Chao	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing process of venous leg ulcers	Clinical assessment of wound healing in surface area (centimeter square)	Postoperative 4~8 weeks
Primary	Healing process of venous leg ulcers	Clinical assessment of wound healing in surface area (centimeter square)	Postoperative 12 weeks
Primary	Healing process of venous leg ulcers	Clinical assessment of wound healing in surface area (centimeter square)	Postoperative 24 weeks
Secondary	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
Secondary	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
Secondary	Venous Clinical Severity Score (VCSS), 0 (minimum) ~ 30 (maximum), higher scores mean a worse outcome	Scoring system of chronic venous insufficiency	Postoperative 12 weeks