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Lymphovenous Bypass Manage Venous Leg Ulcers

Primary Purpose

Venous Leg Ulcer, Lymphovenous Edema

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Lymphovenous bypass, including lymphaticovenular anastomosis/implantation
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Leg Ulcer focused on measuring Chronic Venous Insufficiency, Lymphovenous Bypass

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sung-Chuan ChaoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Venous leg ulcers patients undergoing lymphovenous bypass

Arm Description

Outcomes

Primary Outcome Measures

Healing process of venous leg ulcers
Clinical assessment of wound healing in surface area (centimeter square)
Healing process of venous leg ulcers
Clinical assessment of wound healing in surface area (centimeter square)
Healing process of venous leg ulcers
Clinical assessment of wound healing in surface area (centimeter square)

Secondary Outcome Measures

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.
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.
Venous Clinical Severity Score (VCSS), 0 (minimum) ~ 30 (maximum), higher scores mean a worse outcome
Scoring system of chronic venous insufficiency

Full Information

First Posted
September 6, 2021
Last Updated
June 21, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05068258
Brief Title
Lymphovenous Bypass Manage Venous Leg Ulcers
Official Title
Lymphovenous Bypass (LVB) Promotes Healing Process of Venous Leg Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
October 1, 2026 (Anticipated)
Study Completion Date
October 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer, Lymphovenous Edema
Keywords
Chronic Venous Insufficiency, Lymphovenous Bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Venous leg ulcers patients undergoing lymphovenous bypass
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Lymphovenous bypass, including lymphaticovenular anastomosis/implantation
Intervention Description
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 Outcome Measure Information:
Title
Healing process of venous leg ulcers
Description
Clinical assessment of wound healing in surface area (centimeter square)
Time Frame
Postoperative 4~8 weeks
Title
Healing process of venous leg ulcers
Description
Clinical assessment of wound healing in surface area (centimeter square)
Time Frame
Postoperative 12 weeks
Title
Healing process of venous leg ulcers
Description
Clinical assessment of wound healing in surface area (centimeter square)
Time Frame
Postoperative 24 weeks
Secondary Outcome Measure Information:
Title
The venous leg ulcer quality of life (VLU-QoL) questionnaire (Chinese version verified), 0 (minimum) ~ 100 (maximum), higher scores mean a worse outcome
Description
The questionnaire evaluates 3 dimesions including activities, psychological and symptom distress aspect of patient having venous leg ulcers.
Time Frame
Preoperative
Title
The venous leg ulcer quality of life (VLU-QoL) questionnaire (Chinese version verified), 0 (minimum) ~ 100 (maximum), higher scores mean a worse outcome
Description
The questionnaire evaluates 3 dimesions including activities, psychological and symptom distress aspect of patient having venous leg ulcers.
Time Frame
Postoperative 12 weeks
Title
Venous Clinical Severity Score (VCSS), 0 (minimum) ~ 30 (maximum), higher scores mean a worse outcome
Description
Scoring system of chronic venous insufficiency
Time Frame
Postoperative 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung-Chuan Chao, MD, PhD
Phone
+886-2312-3456
Ext
3468
Email
chao1977@ntuh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Chuan Chao, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sung-Chuan Chao
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Chuan Chao, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Lymphovenous Bypass Manage Venous Leg Ulcers

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