Ignite Creation Date:
2024-05-06 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05068258
Status:
COMPLETED
Last Update Posted:
2023-06-23
First Post:
2021-09-06
Brief Title:
Lymphovenous Bypass Manage Venous Leg Ulcers
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Lymphovenous Bypass LVB Promotes Healing Process of Venous Leg Ulcers
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 aka 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 refractoryrecurrent chronic VLUs The preliminary results revealed promising results and the investigators would go on clinical trials
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 refractoryrecurrent chronic VLUs The preliminary results revealed promising results and the investigators would go on clinical trials
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None