Venous Leg Ulcer (VLU)

17

Review clinical trials related to Venous Leg Ulcer (VLU). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Smart Bandage With Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial

Venous leg ulcers (VLUs) are chronic wounds that are often slow to heal and can greatly affect patients' daily lives. This study will evaluate a new "smart bandage" that can monitor wound conditions such as pH, temperature, and moisture, and transmit this information to a mobile app for nurses to review. Care can then be adjusted in real time. The purpose of this randomized controlled trial is to compare smart bandage plus standard wound care with standard wound care alone. We will assess whether the smart bandage improves healing rates within 12 weeks, shortens time to healing, reduces infection, and improves quality of life in patients with VLUs. About 110 adult participants with VLUs will be enrolled at Clinic Podiatry Care, Purwokerto, Indonesia.

Participants needed: 110
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Asmat BurhanUpdated: Jun 4, 2026Locations: 1
Eligibility criteria

Adults aged 18 to 65 years [+2]

Age >65 years (elderly patients excluded) [+5]

Status: Not yet recruiting

A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers

Venous leg ulcers (VLUs) account for approximately 70% of all lower limb ulcers and affect an estimated 0.032% to 1% of the population in Western countries, corresponding to approximately 265,000 to 650,000 individuals in France. Effective management of VLUs is essential to reduce patient burden and associated healthcare costs. Compression therapy is the cornerstone of VLU treatment , as it improves venous return, reduces oedema, and promotes wound healing. Multilayer compression bandage systems, including two-layer systems, are considered the gold standard, and in France, they are recommended as first-line treatment for VLUs. The goal of this clinical trial is to evaluate whether the Mepi™ Press 2 compression system is non-inferior to UrgoK2® in the treatment of venous leg ulcers in adult patients. The main question it aims to answer is: -Is Mepi™ Press 2 non-inferior to UrgoK2® in terms of the proportion of completely healed VLUs within 12 weeks? Researchers will compare Mepi™ Press 2 with UrgoK2® to determine whether similar clinical efficacy, performance, and safety can be achieved. Participants are adult patients with venous leg ulcers of less than 24 months duration requiring treatment with a two-layer compression bandage system. The study is multicenter, involving approximately 25 sites in France, and plans to enroll 386 participants. Participants will: * Receive compression therapy with either Mepi™ Press 2 or UrgoK2® in accordance with standard of care * Receive an appropriate primary wound dressing prior to compression * Attend up to five study visits over a period of up to 12 weeks (or until wound healing, whichever occurs first) * Be assessed for wound healing, safety, and device performance throughout the study

Participants needed: 386
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Molnlycke Health Care ABUpdated: May 20, 2026Locations: 8
Eligibility criteria

Patients ≥ 18 years. [+6]

Any contraindication to investigational or comparator medical devices mentioned... [+7]

Status: Not yet recruiting

Effect of Photobiomodulation on Healing of Venous Leg Ulcers

This randomized, controlled, double-blind clinical trial will evaluate the efficacy of photobiomodulation (PBM) combined with compression therapy in the healing of venous ulcers (VUs) in the lower limbs. A total of 96 participants will be allocated into two groups: Experimental Group (PBM + compression) and Control Group (sham PBM + compression). Treatments will be administered twice weekly for 16 weeks (32 sessions). The primary outcome will be complete wound healing. Secondary outcomes include changes in ulcer area and volume, pain (VAS), quality of life (SF-36), clinical severity (VCSS), wound quality (Bates-Jensen Scale), infrared thermography, and treatment costs. Data will be analyzed using ANOVA or Kruskal-Wallis, chi-square or Fisher's exact test, and Kaplan-Meier survival analysis, with a significance level of p \< 0.05.

Participants needed: 96
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: University of Nove de JulhoUpdated: Apr 29, 2026Locations: 1
Eligibility criteria

Patients of both sexes; [+3]

Patients with ulcers of non-venous etiology; [+2]

Status: Recruiting

A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)

The main objective of this study is: To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU).

Participants needed: 216
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: MediWound LtdUpdated: Apr 2, 2026Locations: 25
Eligibility criteria

Men or women, older than 18 years of age, [+5]

Wound size that has decreased by > 20% after 7 (+3/-1) days of the screening per... [+24]

Status: Not yet recruiting

EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF VENOUS OR MIXED LEG ULCERS PRESENTING INFLAMMATORY SIGNS SUGGESTING HEAVY BACTERIAL LOAD

Evaluation of the efficacy (reduction of inflammatory signs suggesting a local infection) and tolerance (emergence and nature of adverse event) of Vashe solution vs Saline solution in the treatment of venous or mixed leg ulcers presenting inflammatory signs suggesting heavy bacterial load

Participants needed: 102
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Laboratoires URGOUpdated: Mar 4, 2026Locations: 1
Eligibility criteria

Adult patient, at least 18 years of age or older who has provided free, written,... [+4]

Pregnant or breastfeeding patient, [+5]

Status: Not yet recruiting

Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing

The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics allograft products with real-world evidence to support the clinical adoption in patients to manage chronic or surgical wounds.

Participants needed: 300
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Cellution BiologicsUpdated: Mar 3, 2026
Eligibility criteria

18 years of age or older. [+5]

AmchoPlast dHPT product was not applied to wound. [+4]

Status: Recruiting

A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.

The study is a multicenter, prospective, controlled modified multi-platform trial assessing the efficacy of human placental membrane products and standard of care in the management of nonhealing diabetic foot ulcers and venous leg ulcers.

Participants needed: 50
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: BioLab HoldingsUpdated: Feb 9, 2026Locations: 1
Eligibility criteria

The potential subject must be at least 18 years of age or older. [+6]

The potential subject is known to have a life expectancy of < 6 months. [+19]

Status: Not yet recruiting

ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds

Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds. In this study, the focus is on Venous Leg Ulcers (VLUs). Chronic wounds are wounds that do not heal properly or take a long time to heal. They can cause pain, discomfort, and affect your day-to-day life. These types of wounds are also challenging for healthcare teams to treat and can take up a lot of healthcare resources. Venous Leg Ulcers (VLUs) are the most common type of chronic leg wound and affect about 1 in every 100 people. Usual treatments for VLUs include cleaning the wound, using special dressings, applying pressure (compression therapy), and sometimes using creams or dressings that contain silver to fight infection. This study is being done to see if the wound therapy system can help heal venous leg ulcers more effectively and safely.

Participants needed: 87
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: ConvaTec Inc.Updated: Jan 29, 2026
Eligibility criteria

A wound which is amenable to NPWT and is a VLU as defined by CEAP Classification... [+4]

Known sensitivities or allergies to components of the ConvaVAC™ Ag+ NPWT System [+14]

Status: Recruiting

A Non-Randomized Open Label Clinical Trial Evaluating DermaBind TL

The purpose of this clinical evaluation is to collect patient outcome data and evaluate the efficacy, safety and tolerability of HealthTech DermaBind TL™ in patients with chronic non-healing wounds in patients with chronic non-healing ulcers.

Participants needed: 150
Trial details
Phase: Phase 4Age: 18-80Biological sex: AllType: InterventionalSponsor: HealthTech Wound CareUpdated: Dec 23, 2025Locations: 10
Eligibility criteria

1. Be an adult between 18 and 80 years of age at the time of consent 2. Presence... [+6]

1. Pregnant or lactating 2. Less than 18 years of age 3. Has continued tobacco u...

Status: Not yet recruiting

Nonhealing Venous Leg Ulcers Treated With a Standard of Care (SoC) Alone or Standard of Care and Dehydrated Human Placenta Tissue (dHPT) With Crossover

The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of venous leg ulcers.

Participants needed: 70
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Cellution BiologicsUpdated: Dec 16, 2025
Eligibility criteria

18 years of age or older. [+8]

The participant must agree to attend the weekly study visits required by the pro... [+16]

Status: Not yet recruiting

Assessing Sensor-Guided Compression Therapy for Venous Leg Ulcers Healing Outcomes

The investigators are conducting a study to find out if a new system can help improve the care of people with venous leg ulcers (VLU). Venous leg ulcers are wounds on the lower leg that need compression bandages to help them heal. In this study, patients will be randomly placed into one of two groups: * Group 1: Will receive the usual care for VLUs. * Group 2: Will use a new connected health system, called Tight Alright, along with their usual care. The Tight Alright system includes a small, wearable device that sits under a patient's bandage. This device measures the pressure at three points on the patient's lower leg and sends the information wirelessly to a mobile app. The app shows real-time pressure readings and also sends the data to a secure cloud database. This allows the patient's healthcare team to monitor their bandage pressure remotely and make sure it is just right. The aim is to help nurses and doctors apply the correct pressure every time, which is important for healing. The system can also alert the patient's healthcare team if the pressure drops, so they can decide if a patient's bandage needs adjusting, even when the patient is at home. The investigators will follow all participants for 90 days and then compare how well the ulcers have healed in both groups. This will help us find out if the new system can improve healing and make treatment safer and more effective.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Feeltect LimitedUpdated: Dec 5, 2025Locations: 1
Eligibility criteria

Adults with chronic venous leg ulcers (≥6-week and ≤5-year durations) currently... [+3]

Uncontrolled diabetes [haemoglobin A1c (HbA1c) ≥12% in the last 3 months] [+15]

Status: Recruiting

Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers

The purpose of this study is to evaluate the efficacy, safety and economic benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of venous leg ulcers. Participants will utilize standard of care (SOC) multilayer compression dressings with an inactive wound contact layer. Following a 2-week run-in period with SOC and after meeting all eligibility criteria, subjects will be randomized in a 1:1 ratio with TWO2 therapy or sham control therapy plus SOC. Participants will enter the intervention period of up to 16-weeks, followed by a long-term follow-up period of 52 weeks post randomization.

Participants needed: 212
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: AOTI Ltd.Updated: Nov 19, 2025Locations: 1
Eligibility criteria

Adults ≥ 18 years and able to provide written informed consent [+10]

• Known allergy to any of the protocol-stipulated treatments, or non-tolerance o... [+18]

Status: Recruiting

Reducing Skin Tone Inequities in Chronic Venous Insufficiency

The aim of this project is to define assessment criteria for chronic venous insufficiency (CVI) in people with dark skin tones. It will inform future interventions and modifications to practice for the assessment of CVI in people with dark skin tones in a nurse led intervention to improve patient assessment. To achieve this there will be two parts to this study. 1. We will explore patient journeys and patient experiences of people with dark skin tones diagnosed with chronic venous insufficiency. From this we will learn from people with dark skin tones about how they recognised skin changes in their lower legs to further inform clinical assessment guidance and techniques. We will also listen to their patient journey to identify what areas worked well and what could be developed. This will help us plan how care could be improved for similar people. 2. We will record how skin changes look and feel in people with dark skin tones and known venous disease, and photograph this. We will consider whether some additional techniques used in practice to look and feel the skin is useful and whether changing the colour balance and manipulating the photographs is useful to see these skin changes.

Participants needed: 51
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: King's College LondonUpdated: Sep 16, 2025Locations: 2
Eligibility criteria

the person with chronic venous insufficiency has a dark skin tone (from Ho and R... [+1]

person with chronic venous insufficiency has a light skin tone (from Ho and Robi... [+10]

Status: Recruiting

Safety and Preliminary Efficacy of TrophiPatch, an Adipose-Derived Stromal Cell Patch for Chronic Leg Ulcers

This study aims to evaluate the safety and effectiveness of an experimental biological dressing called TrophiPatch, applied to adults with chronic leg ulcers of diabetic or vascular orign. TrophiPatch contains stromal cells derived from a donor's fat tissue, which are purified and processed in a certified laboratory. These cells have shown wound-healing, anti-inflammatory and pro-angiogenic properties in preclinical studies. All 18 participants will receive a single application of TrophiPatch on their wound. The total study duration is up to 24 weeks, with 23 scheduled visits for follow-up and monitoring.

Participants needed: 18
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Nicolò BrembillaUpdated: Jul 2, 2025Locations: 1
Eligibility criteria

Age 18 years or older. [+16]

endstage renal disease [+23]

Status: Not yet recruiting

Evaluation of Cold Plasma in Chronic Wound Healing

The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds. The main questions is the following: Does the application of cold atmospheric plasma accelerate wound healing compared to standard wound care alone? Researchers will compare standard of care plus plasma treatment with standard of care alone to see if the plasma-treated group shows faster wound healing. Participants will: * Receive either standard wound care alone or standard wound care combined with cold atmospheric plasma treatment, depending on randomization. * Attend scheduled hospital visits for wound care, treatment administration, and clinical assessments, including wound photography and quality of life questionnaires. * Be followed up at home by nurses for wound care, treatment administration and clinical assessment too. * Complete a wound-related quality of life questionnaire at baseline, at week 6, and at the end of the study.

Participants needed: 66
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Plasana MedicalUpdated: May 9, 2025
Eligibility criteria

Adult patient, age ≥ 18 years, [+22]

Patients with any other wound treatments other than SOC, Patients who has underg... [+13]

Status: Recruiting

Evaluating the Durability of Closure for Venous Leg Ulcers

The goal of this observational study is to determine the durability of closure for venous leg ulcer subjects that achieved closure in the THOR trial.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Kerecis Ltd.Updated: Jan 24, 2025Locations: 1
Eligibility criteria

1. Subjects must have participated in the THOR trial and achieved complete closu...

1. Subjects who did not participate in the THOR trial. 2. Subjects who participa...

Status: Recruiting

Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers

The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of hard-to-heal venous leg ulcers (VLU) between Intact Fish Skin Graft plus standard of care (IFSG/SOC) versus standard of care alone (SOC) over 12 weeks.

Participants needed: 150
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Kerecis Ltd.Updated: Jan 24, 2025Locations: 1
Eligibility criteria

Subjects must be at least 18 years of age or older. [+8]

Subjects must have a Functional Ambulatory Category Score (FACS) of 3 or greater... [+27]