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Completed

NCT Number: NCT05068258

Lymphovenous Bypass Manage Venous Leg Ulcers

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sung-Chuan Chao

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Healing process of venous leg ulcers

    Time frame: Postoperative 4~8 weeks

    Clinical assessment of wound healing in surface area (centimeter square)

  2. Healing process of venous leg ulcers

    Time frame: Postoperative 12 weeks

    Clinical assessment of wound healing in surface area (centimeter square)

  3. Healing process of venous leg ulcers

    Time frame: Postoperative 24 weeks

    Clinical assessment of wound healing in surface area (centimeter square)

Secondary outcomes

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

    Time frame: Preoperative

    The questionnaire evaluates 3 dimesions including activities, psychological and symptom distress aspect of patient having venous leg ulcers.

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

    Time frame: Postoperative 12 weeks

    The questionnaire evaluates 3 dimesions including activities, psychological and symptom distress aspect of patient having venous leg ulcers.

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

    Time frame: Postoperative 12 weeks

    Scoring system of chronic venous insufficiency

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 5, 2021
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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