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Study on the Effectiveness of EscharEx and Amnion/Chorion Membrane Allograft for Patients with Venous Leg Ulcers

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of , which are wounds that occur on the legs due to poor blood flow in the veins. The study will evaluate the effectiveness and safety of a treatment called , which is a powder that turns into a gel when applied to the wound. This gel contains a special ingredient known as a , which helps in cleaning the wound by removing dead tissue. The study will also use a for comparison, which looks like the treatment gel but does not contain the active ingredient.

The purpose of the study is to see how well works in cleaning and preparing the wound bed for healing. Participants in the study will receive either the treatment or the placebo. The treatment will be applied directly to the wound, and the progress will be monitored over a period of time. The study will also involve the use of an , which is a patch made from human tissue, to help with the healing process. This patch is applied to the wound to support the growth of healthy tissue.

Throughout the study, the main focus will be on how effectively the treatment cleans the wound and helps it to close completely. The study will also look at how quickly the wound area changes and how soon healthy tissue forms. Participants will have regular visits to check the progress of their wound healing. The study aims to provide valuable information on the potential benefits of for people with .

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the nature of the procedure and will provide written informed consent. This step ensures that the patient understands the study and agrees to participate.
Step 2
Daily visits period
During this period, the patient will receive up to 8 applications of the study treatment. The treatment involves the use of EscharEx, a powder for gel, or a Placebo (Gel Vehicle). The treatment is applied topically on the wound.
The main goal during this period is to assess the incidence of complete debridement, which means the removal of dead or damaged tissue from the wound. This is visually assessed after each application.
Step 3
Weekly visits period
Following the daily visits period, the patient will enter the weekly visits period. During this time, the focus is on monitoring the wound for complete closure and the development of healthy tissue.
The time taken for complete debridement and wound closure will be assessed. Changes in the wound area will also be measured using a tool called eKare inSightTM.
Step 4
End of study participation
At the end of the study, the patient's progress will be evaluated based on the primary and secondary endpoints. These include the incidence of complete debridement and wound closure, as well as the development of healthy tissue.
The study aims to ensure the safety and efficacy of the treatment for venous leg ulcers.

Who can join the trial?

6 criteria

Men or women, older than 18 years of age
Patients with a venous leg ulcer (a type of sore on the leg caused by poor blood flow in the veins, confirmed by medical history, physical examination, and an ultrasound scan showing venous insufficiency)
The wound has been present for at least 4 weeks but no longer than 1 year
The area of dead or non-living tissue (called necrotic/slough/fibrin) covers at least 50% of the wound area, as determined by a healthcare professional
The size of the target wound is between 2 and 25 square centimeters, measured by a specific tool called eKare inSightTM
The patient understands the nature of the procedure, can follow the study plan, and has signed a written consent form before any study procedures begin

Who cannot join the trial?

4 criteria

Patients who do not have a venous leg ulcer cannot participate. A venous leg ulcer is a sore on the leg that takes a long time to heal, often due to poor blood flow.
Patients who are not within the specified age range cannot participate. The study includes adults and older adults.
Both male and female patients can participate, but those who do not identify as either cannot participate.
Patients who are considered part of a vulnerable population cannot participate. This means people who might be at a higher risk of harm or exploitation.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Ospedaliera di Padova
Padua, Italy
Verified
Azienda Ospedaliero Universitaria Di Modena
Modena, Italy
Responsive
Katholisches Klinikum Bochum gGmbH
Bochum, Germany

Trial locations

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Investigated drugs

EscharEx is a treatment being studied for its ability to help clean and prepare wounds, specifically venous leg ulcers, for healing. Venous leg ulcers are sores that occur on the legs due to poor blood circulation. EscharEx works by removing dead tissue from the wound, a process known as debridement, which is important for promoting healing and preventing infection. This study is looking at how effective and safe EscharEx is compared to a gel that does not contain any active medication.

What is already known about the treatment

EscharEx – EscharEx is a topical gel applied directly to the skin, specifically designed for the treatment of venous leg ulcers. It is currently being studied in clinical trials to evaluate its effectiveness and safety in helping to clean and prepare the wound bed by removing dead tissue. The main therapeutic use of EscharEx is to aid in the debridement process, which is crucial for wound healing. At the molecular level, EscharEx works by breaking down proteins in the dead tissue, facilitating its removal. It is classified pharmacologically as a debridement agent.

Investigated diseases

Venous leg ulcer – A venous leg ulcer is a chronic sore that develops on the skin, usually on the lower leg, due to poor blood circulation in the veins. It often begins as a small, shallow wound and can gradually enlarge if not properly managed. The skin around the ulcer may become discolored, swollen, and itchy. Over time, the ulcer can become deeper and more painful, with the potential for infection if not kept clean. The condition is often associated with symptoms such as heaviness, aching, and swelling in the affected leg. Proper care and management are essential to prevent the ulcer from worsening.