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Leg Ulcer clinical trials

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NCT ID: NCT06255288 Recruiting - Venous Leg Ulcer Clinical Trials

Time to Heal (Wound, Healing, Dialogue, Nutrition)

SNAK
Start date: January 23, 2024
Phase: N/A
Study type: Interventional

The objective of this study is to examine the feasibility, acceptability, fidelity, and outcome of a nurse-led nutritional intervention for patients with leg ulcers in a outpatient clinics. The intervention consists of a structured dialogue and patient information on key lifestyle behaviours to improve wound healing. Furthermore, the intervention includes protein supplement.

NCT ID: NCT06236750 Recruiting - Diabetic Foot Ulcer Clinical Trials

Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds

Start date: August 4, 2023
Phase: N/A
Study type: Interventional

The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.

NCT ID: NCT06181708 Recruiting - Venous Leg Ulcer Clinical Trials

Diagnostics in the Leg Ulcer Pathway

Start date: November 13, 2023
Phase:
Study type: Observational

This project aims to investigate 'The minimum diagnostic requirements for patients presenting to primary care with suspected venous ulcers.' In order to do this, the investigators intend to run a series of questionnaires with primary care services, vascular science services, and perform some cost effectiveness modelling on running diagnostic services in primary care and in secondary care settings. A one off questionnaire, designed in Qualtrics, will be sent out to primary care practitioners via social media and email contacts. This will be aimed at establishing their current role and any guidelines they follow with regards to the diagnosis and management of venous leg ulcers in primary care, and to determine their opinion of what this patient pathway should involve. A Delphi consensus will be carried out amongst vascular scientists across the UK to determine current and streamline future practice in diagnostics for patients with venous leg ulcers. The consensus will be achieved when there is ≥ 70% agreement. Cost effectiveness modelling will be carried out on two different scenarios of managing this cohort of patients, one in primary care and one in secondary care settings. Descriptive statistics will be performed on the results.

NCT ID: NCT06135987 Recruiting - Diabetic Foot Ulcer Clinical Trials

Clinical Evaluation in Real Life of TLC-NOSF Dressings in the Local Treatment of Chronic Wounds (DFU and VLU)

STARTLIFE
Start date: June 24, 2022
Phase:
Study type: Observational

The objective of this study is to document the performance and the safety of UrgoStart Plus® Border, UrgoStart Plus® Pad and UrgoStart Interface® in the local treatment of diabetic foot ulcers (neuropathic or neuroischemic - non-critical ischemia) and venous or mixed predominantly venous leg ulcers, in real life conditions and current practice, in France.

NCT ID: NCT06135246 Recruiting - Venous Leg Ulcer Clinical Trials

Laser Therapy for Venous Leg Ulcers

Start date: November 16, 2023
Phase: N/A
Study type: Interventional

This randomized controlled trial will evaluate the effects of high-intensity laser therapy on wound healing in patients with venous leg ulcers. Participants will be randomly assigned to receive either laser therapy plus standard care or standard care alone. The laser therapy will be administered 3 times per week for 8 weeks or until ulcer closure. The primary outcome is proportion of participants with complete ulcer closure.

NCT ID: NCT05923749 Recruiting - Wound Heal Clinical Trials

A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg Ulcers

Start date: June 29, 2023
Phase: N/A
Study type: Interventional

Approximately 178 patients with a venous leg ulcer will be included in the investigation evaluating wound healing. All subjects are randomized to one of two treatment arms with an intervention period of 4 weeks followed by a 8 week standard of care period.

NCT ID: NCT05894096 Recruiting - Venous Leg Ulcer Clinical Trials

Air Cold Atmospheric Pressure Plasma Treatment for Acceleration of Venous Ulcer Healing

PLASFRI-CUV
Start date: March 24, 2023
Phase: N/A
Study type: Interventional

In this medical trial, a novel prototype of a medical device based on a Cold Atmospheric Air Plasma Jet for the treatment is clinically tested on patients with venous leg ulcers. The device is characterized by producing the first cold air plasma jet compatible with living tissues at a low heat transfer rate with a temperature on the skin surface lower than 40 ºC. It has a practical design to be used by physicians during daily practice with a special focus on unhealed ulcers.

NCT ID: NCT05890703 Recruiting - Ulcer, Leg Clinical Trials

Painless Sharp Wound Debridement With Lidocaine-23%-Tetra-caine-7% Gel Versus EMLA 5% Cream

LIDOTETRA
Start date: June 1, 2023
Phase: Phase 2
Study type: Interventional

In a single-blind, crossover, randomized, controlled trial with 40 participants we aim to demonstrate superior anaesthetic efficacy of lidocaine-23%-tetracaine-7% (IMP2) gel over EMLA 5% cream (IMP1) at comparable safety in sharp wound debridement of chronic leg ulcers. This is a monocentric investigator initiated trial conducted in the University Hospital Zurich. In this longitudinal trial, participants receive a sequence of different treatments (treatments on different days) and therefore are randomly assigned to one of two treatment sequences. One-half of participants will first receive IMP1 (first treatment visit, randomized) and then IMP2 (second treatment visit, crossover); the other half of participants the reverse sequence (first treatment visit: IMP2, second treatment visit: IMP1). Primary Objective: We want to show that IMP 2 (lidocaine-23%-tetracaine-7% gel) is more effective in pain reduction than IMP 1 (EMLA® 5% cream) in sharp wound debridement.

NCT ID: NCT05855499 Recruiting - Clinical trials for Chronic Ulcer of Lower Extremity

Plasma On Chronic Wounds for Epidermal Regeneration

POWER
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Every year, 5 million people throughout Germany suffer from extensive, often chronic wounds. Cold plasma is an innovative therapeutic approach in the treatment of these persistent tissue defects. However, previous therapy options with cold plasma are very time-consuming, especially with increasing wound area, and are also strongly dependent on the skill of the practitioner. This study investigates the effectiveness of a system for reproducible application of cold plasma on larger areas and observes the effect of a 4-week additional plasma treatment on wound healing of large chronic wounds. The patient-related benefit of such an additional treatment will also be evaluated. Both study arms will receive guideline-based wound therapy, which is the current gold standard.

NCT ID: NCT05772507 Recruiting - Diabetic Foot Ulcer Clinical Trials

Efficacy and Tolerance of URGO AWC_008 and URGO AWC_022 Dressings (EXPANSION)

Start date: August 22, 2023
Phase: N/A
Study type: Interventional

Evaluation of the efficacy (wound epithelialization and time to closure) and tolerance (emergence and nature of adverse event) of the new URGO AWC_008 and URGO AWC_022 dressings in local management of acute and chronic wounds at risk of local infection or with clinical signs of local infection