Venous Leg UlcerNCT05068258
Lymphovenous Bypass Manage Venous Leg Ulcers
A study testing Lymphovenous bypass, including lymphaticovenular anastomosis/implantation in people with Venous Leg Ulcer and Lymphovenous Edema, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Venous Leg Ulcer, Lymphovenous Edema
- What is being tested?
- Lymphovenous bypass, including lymphaticovenular anastomosis/implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Nov 2021to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lymphovenous Bypass (LVB) Promotes Healing Process of 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.
- Conditions
- Venous Leg Ulcer, Lymphovenous Edema
- Being tested
- Lymphovenous bypass, including lymphaticovenular anastomosis/implantation
- Keywords
- Chronic Venous Insufficiency, Lymphovenous Bypass
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphovenous bypass, including lymphaticovenular anastomosis/implantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Venous leg ulcers patients undergoing lymphovenous bypass | Experimental | Not described Receives: Procedure: Lymphovenous bypass, including lymphaticovenular anastomosis/implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing process of venous leg ulcers
Clinical assessment of wound healing in surface area (centimeter square)
Measured: Postoperative 4~8 weeks
Healing process of venous leg ulcers
Clinical assessment of wound healing in surface area (centimeter square)
Measured: Postoperative 12 weeks
Healing process of venous leg ulcers
Clinical assessment of wound healing in surface area (centimeter square)
Measured: 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
The questionnaire evaluates 3 dimesions including activities, psychological and symptom distress aspect of patient having venous leg ulcers.
Measured: 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.
Measured: Postoperative 12 weeks
Venous Clinical Severity Score (VCSS), 0 (minimum) ~ 30 (maximum), higher scores mean a worse outcome
Scoring system of chronic venous insufficiency
Measured: Postoperative 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start2 Nov 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sung-Chuan Chao, MD, PhD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068258
- Sponsor's protocol ID
- 202105094RIND
- Status last verified
- Mar 2024
- First submitted
- 6 Sep 2021
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphovenous Bypass (LVB) Promotes Healing Process of Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT05068258
- Acronym / sponsor ID
- 202105094RIND
- Conditions
- Venous Leg Ulcer, Lymphovenous Edema
- Keywords
- Chronic Venous Insufficiency, Lymphovenous Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venous leg ulcers patients undergoing lymphovenous bypass | Experimental | Procedure: Lymphovenous bypass, including lymphaticovenular anastomosis/implantation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymphovenous bypass, including lymphaticovenular anastomosis/implantationLymphovenous 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. | Procedure or surgery | Venous leg ulcers patients undergoing lymphovenous bypass |
Primary outcome
Healing process of venous leg ulcers
Time frame: Postoperative 4~8 weeks
Clinical assessment of wound healing in surface area (centimeter square)
Healing process of venous leg ulcers
Time frame: Postoperative 12 weeks
Clinical assessment of wound healing in surface area (centimeter square)
Healing process of venous leg ulcers
Time frame: Postoperative 24 weeks
Clinical assessment of wound healing in surface area (centimeter square)
3 secondary outcomes
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 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
Venous Clinical Severity Score (VCSS), 0 (minimum) ~ 30 (maximum), higher scores mean a worse outcome
Time frame: Postoperative 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Chuan Chao, MD, PhD study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphovenous bypass, including lymphaticovenular anastomosis/implantation in people with Venous Leg Ulcer and Lymphovenous Edema, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing process of venous leg ulcers (time frame: Postoperative 4~8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.