Ongoing Clinical Trials for Skin Ulcer
There are currently 5 clinical trials studying new treatments for skin ulcers, including chronic venous leg ulcers and other types of non-healing wounds. These trials are testing different approaches such as stem cell therapy, wound-cleaning medications, and cell-based treatments to help improve healing in patients whose wounds have not responded to standard care.
Clinical trial locations
- Austria
- Czechia
- France
- Germany
- Study on the Effectiveness of EscharEx and Amnion/Chorion Membrane Allograft for Patients with Venous Leg Ulcers
- Study on the Effectiveness and Safety of allo-APZ2-CVU for Healing Chronic Venous Ulcers in Patients with Therapy-Resistant Wounds
- Study on the Effectiveness of Allo-APZ2-CVU for Patients with Long-Term, Non-Healing Venous Leg Ulcers
- Hungary
- Italy
- Netherlands
- Poland
- Slovakia
- Spain
- Sweden
Study on Stem Cell Treatment for Venous Ulcers in the Legs Using Bioengineered Artificial Mesenchymal Sheet (BAMS)
This trial is testing a new approach to healing venous leg ulcers using stem cell therapy. The treatment involves a Bioengineered Artificial Mesenchymal Sheet (BAMS), which contains special cells called mesenchymal stem cells grown on a supportive structure made of fibrin and hyaluronic acid.
Inclusion criteria: Participants must be over 18 years old and have an active or recurring venous ulcer on their lower leg measuring between 5 and 10 square centimeters. The ulcer should be classified as Grade III on the Widmer scale, which assesses the severity of venous disease. Patients must have palpable distal pulses in their lower limbs, meaning doctors can feel blood flow in the leg and foot. An Ankle-Brachial Index (ABI), which compares blood pressure in the ankle with the arm, must be between 0.8 and 1.3.
Exclusion criteria: The trial excludes patients outside the specified age range and those who belong to vulnerable populations who may have difficulty giving informed consent or are at higher risk of harm.
Focus: The main goal is to assess the safety and feasibility of BAMS treatment. Researchers will also evaluate how well the treatment helps close wounds, the time it takes for healing, changes in growth factors related to wound healing, pain levels, and quality of life improvements.
Investigational drug: The study uses allogenic adipose-derived adult mesenchymal stem cells, which are special cells taken from donor fat tissue and expanded on a biological matrix. These cells are applied directly to the wound to promote healing.
Study on the Effectiveness of EscharEx and Amnion/Chorion Membrane Allograft for Patients with Venous Leg Ulcers
This trial evaluates EscharEx, a powder that turns into a gel when applied to wounds. The gel helps clean wounds by removing dead tissue, a process called debridement, which is essential for proper healing.
Inclusion criteria: Participants must be over 18 years old with a venous leg ulcer confirmed by medical history, physical examination, and ultrasound showing venous insufficiency. The wound must have been present for at least 4 weeks but no longer than 1 year. Dead or non-living tissue must cover at least 50% of the wound area, and the wound size should be between 2 and 25 square centimeters.
Exclusion criteria: The trial excludes patients without venous leg ulcers, those outside the specified age range, and those in vulnerable populations.
Focus: The primary goal is to assess how effectively EscharEx removes dead tissue from wounds. Secondary objectives include monitoring complete wound closure, the time needed for debridement and healing, changes in wound area, the development of healthy tissue, and any side effects.
Investigational drug: EscharEx is a topical gel applied directly to the wound to facilitate debridement and prepare the wound bed for healing. The study compares it to a placebo gel without active ingredients.
Study on Acetic Acid for Healing Skin Ulcers in Patients with Biofilm
This study examines whether acetic acid can help heal ulcers complicated by biofilm, which is a layer of bacteria that forms on wounds and makes healing more difficult.
Inclusion criteria: Patients must be over 18 years old and receiving continuous care either in a hospital or as an outpatient. They must have an ulcer with biofilm that is less than 120 square centimeters and located anywhere on the body except the face. Patients should be able to commit to treatment and follow-up for at least 8 weeks and participate in necessary evaluations.
Exclusion criteria: The trial excludes patients with ulcers complicated by biofilm who are outside the specified age range, not part of the designated study groups, or belonging to vulnerable populations.
Focus: The main objective is to measure the change in ulcer area over 8 weeks. Secondary goals include assessing the percentage of patients with complete healing at 4, 8, and 12 weeks, the time to healing, healthcare costs, and any adverse reactions.
Investigational drug: Acetic acid is applied topically to the wound. It has antibacterial properties that may help break down biofilm and promote healing.
Study on the Effectiveness and Safety of allo-APZ2-CVU for Healing Chronic Venous Ulcers in Patients with Therapy-Resistant Wounds
This trial tests allo-APZ2-CVU, a cell therapy using special cells derived from skin, for patients whose chronic venous ulcers have not responded to other treatments.
Inclusion criteria: Participants must be at least 18 years old with a chronic venous leg ulcer on the lower leg or ankle that has not been present for more than 15 years. The diagnosis should be confirmed through imaging tests like Doppler or duplex sonography, physical examination, and skin review. The ulcer should measure between 1 and 50 square centimeters. Body mass index must be between 15 and 50 kg/m². Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study.
Exclusion criteria: The trial excludes patients outside the age range, those unable to follow study procedures, pregnant or breastfeeding women, those who recently participated in another trial, patients with allergies to study medication, and those with severe health conditions that might interfere with the study.
Focus: The primary goal is to evaluate complete wound closure at Week 18 that persists for at least two weeks, while monitoring safety. Secondary objectives include assessing wound closure at follow-up visits, changes in wound size, time to healing, quality of life, pain levels, and wound recurrence.
Investigational drug: allo-APZ2-CVU is a cutaneous suspension containing special skin cells applied directly to the wound to promote healing.
Study on the Effectiveness of Allo-APZ2-CVU for Patients with Long-Term, Non-Healing Venous Leg Ulcers
This Phase III trial further evaluates allo-APZ2-CVU in a larger patient population with chronic venous ulcers that have not healed with standard treatments.
Inclusion criteria: Patients must be at least 18 years old with a chronic venous leg ulcer on the lower leg or ankle that has not been present for more than 15 years. Diagnosis should be confirmed through Doppler or duplex sonography, ankle brachial index between 0.9 and 1.3 (or toe brachial index of at least 0.7 if ABI cannot be measured), and physical examination. The wound should measure between 1 and 25 square centimeters. If multiple ulcers are present, the main ulcer must be at least 1 cm away from others with healthy skin in between. Body mass index must be between 15 and 50 kg/m². Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
Exclusion criteria: The trial excludes patients with other types of wounds, those outside the age range, patients unable to follow study procedures, those with interfering medical conditions, pregnant or breastfeeding women, patients participating in other trials, those with allergies to study substances, and individuals with drug or alcohol abuse history or mental health conditions that could affect participation.
Focus: The primary endpoint is complete wound closure at Week 18 persisting for at least two weeks. Secondary objectives include wound closure assessments at each follow-up visit, changes in wound size, quality of life evaluations, pain levels, duration of wound closure, and recurrence monitoring.
Investigational drug: Allo-APZ2-CVU is a regenerative medicine product applied topically to wounds. It contains allogeneic skin-derived cells designed to enhance the body’s natural healing processes.
Summary
The five ongoing clinical trials for skin ulcers focus primarily on chronic venous leg ulcers, which are challenging wounds that do not heal with standard care. These trials are testing innovative approaches including stem cell therapies, wound debridement agents, and antibacterial treatments.
Geographically, the trials show a concentration in European countries, with Germany, Poland, Austria, and Italy hosting multiple studies. Spain is conducting two unique trials focusing on stem cell therapy and acetic acid treatment. The largest trial, studying allo-APZ2-CVU, spans ten countries across Europe, indicating significant international collaboration in wound healing research.
Two trials are specifically testing allo-APZ2-CVU, a cell-based therapy, at different phases of clinical development. This suggests growing interest in regenerative medicine approaches for therapy-resistant wounds. Other notable treatments include BAMS (stem cell sheet), EscharEx (debridement gel), and acetic acid for biofilm-complicated wounds.
Most trials require participants to have wounds that have persisted for extended periods and have not responded to conventional treatments, highlighting the focus on addressing unmet medical needs for patients with difficult-to-heal ulcers.
