Lymphovenous Bypass Manage Venous Leg Ulcers

NCT05068258 | Completed

• 1 other identifier: 202105094RIND
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Leg Ulcer; Lymphovenous Edema

Keywords

Chronic Venous Insufficiency; Lymphovenous Bypass

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• The venous leg ulcer quality of life (VLU-QoL) questionnaire (Chinese version verified), 0 (minimum) ~ 100 (maximum), higher scores mean a worse outcome

  Preoperative

• The venous leg ulcer quality of life (VLU-QoL) questionnaire (Chinese version verified), 0 (minimum) ~ 100 (maximum), higher scores mean a worse outcome

  Postoperative 12 weeks

• Venous Clinical Severity Score (VCSS), 0 (minimum) ~ 30 (maximum), higher scores mean a worse outcome

  Postoperative 12 weeks

Study Arms (1)

Venous leg ulcers patients undergoing lymphovenous bypass

EXPERIMENTAL

Procedure: Lymphovenous bypass, including lymphaticovenular anastomosis/implantation

Interventions

Lymphovenous bypass, including lymphaticovenular anastomosis/implantation PROCEDURE

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.

Venous leg ulcers patients undergoing lymphovenous bypass

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Sung-Chuan Chao

Taipei, Taiwan

Location

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Sung-Chuan Chao, MD, PhD

  National Taiwan University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: October 5, 2021
• Study Start: November 2, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)