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Leg Ulcer clinical trials

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NCT ID: NCT05303805 Recruiting - Leg Ulcer Clinical Trials

Topical Sevoflurane for Treatment of Chronic Leg Ulcers

Start date: May 2, 2022
Phase: Phase 4
Study type: Interventional

Patients with painful non-healing leg ulcer will be enrolled in the clinical single-blinded randomized study. The active treatment group will have sevoflurane applied at approximately 1 ml/cm2 at the start of wound treatment, the control group will only have a standard rinse solution with Cyteal TM (Pierre Fabre Medicament, France). Further treatment will then be carried out in the standard manner. The duration of the study will be 5 days; if the defect heals earlier, it will be terminated early. Exclusion criteria: allergy to sevoflurane, inability to understand the questionnaire Parameters to be monitored will be pain intensity, microbial colonization, appearance and size of the defect

NCT ID: NCT05274295 Recruiting - Diabetic Foot Ulcer Clinical Trials

Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Diabetic Leg Ulcers

Start date: February 28, 2022
Phase: N/A
Study type: Interventional

To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with diabetic leg ulcers.

NCT ID: NCT05165459 Recruiting - Venous Leg Ulcer Clinical Trials

Open Label Single Arm Proof of Concept Trial to Evaluate the Efficacy and Safety of Cytori Celution System in Chronic Non-Healing Venous Leg Ulcers

Start date: November 29, 2021
Phase: N/A
Study type: Interventional

To evaluate the efficacy and safety of Cytori Celution System in Hungarian patients with chronic non-healing venous leg ulcers.

NCT ID: NCT05134597 Recruiting - Inflammation Clinical Trials

Gene Expression in Chronic Venous Leg Ulcers

GECVELUS
Start date: January 1, 2021
Phase:
Study type: Observational

Chronic Venous Disease (CVD) is a widespread clinical condition widely spread in the western countries that may negatively impact the quality of life (QoL) of affected patients. Chronic venous leg ulcers (CVLUs) are the most severe form of CVD, and several genetic and molecular alterations have been studied in order to understand the progression of CVD towards CLVUs. Chronic inflammation is a key element in CVLUs onset, and recently T helper 17 (Th-17) cells, a subtype of pro-inflammatory T helper (CD4+) cells defined by the production of a cytokine signature of which IL-17 represents the progenitor, seem to be related to several chronic disease. The aim of this study is to evaluate Th17- Gene Expression profile in patients with CVD and CVLUs.

NCT ID: NCT05068258 Recruiting - Venous Leg Ulcer Clinical Trials

Lymphovenous Bypass Manage Venous Leg Ulcers

Start date: November 2, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04995432 Recruiting - Venous Leg Ulcer Clinical Trials

Non Contrast MRI in Lower Extremity

Start date: January 1, 2018
Phase:
Study type: Observational

We collected retrospectively the non contrast MRI in chia yi memorial hospital for different venous disease of lower extremity morphology and flow ananlysis were done.

NCT ID: NCT04980898 Recruiting - Leg Ulcer Clinical Trials

Electrostimulation System WoundEL for Leg Ulcers Healing (

ELEXICA
Start date: March 16, 2021
Phase: N/A
Study type: Interventional

Several studies have suggested that the endogenous electric field and its polarity stimulate the proliferation and migration of epithelial cells and therefore promote wound healing. WoundEL® will reproduce the endogenous electrical current to stimulate all the factors contributing to healing. Electrostimulation of wounds, including the WoundEL® device, is a therapy listed but not yet reimbursed in France. The aim of this study is to show that the WoundEL® electrostimulation device is superior to the reference treatments recognized by the HAS.

NCT ID: NCT04920253 Recruiting - Diabetic Foot Ulcer Clinical Trials

Real World Evidence With the Debritom+ TM Novel Micro Water Jet Technology at a Single Wound Center

EVIDENT
Start date: November 29, 2021
Phase: N/A
Study type: Interventional

Prospective, single-blinded, single-center, parallel group, randomized controlled trial (RCT) to assess rate and frequency of wound healing and associated financial savings, when using Medaxis debritom+ versus standard of care as a choice of debridement method, where both arms follow normal wound care practice in use of advanced wound care treatments.

NCT ID: NCT04902612 Recruiting - Venous Leg Ulcer Clinical Trials

HM242-Solution vs Comparator

Start date: May 25, 2021
Phase: N/A
Study type: Interventional

The objectives of this study include investigating the performance of HM242-Solution compared to normal Saline with respect to venous leg ulcer healing. Saline is widely used for venous leg ulcer cleansing and has served as comparator or standard treatment in clinical trials evaluating new cleansing products to prove that it is as good as the standard treatment. Data will also be collected on the patients' quality of life and any adverse events that may arise during the study.

NCT ID: NCT04901013 Recruiting - Venous Leg Ulcer Clinical Trials

Clinical Study Of Affinity Versus SOC In The Management Of VLUs

Start date: June 14, 2021
Phase: N/A
Study type: Interventional

This prospective, multi-center, randomized, controlled clinical study compares Affinity® plus SOC to SOC alone in subjects with VLUs. Affinity® will be used along with standard of care on venous leg ulcers (VLUs) of greater than 4 weeks which have not adequately responded to conventional ulcer therapy.