Clinical trials: Venous Leg Ulcer (VLU)
Venous Leg Ulcer
A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers
The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-VLU when administered as a single topical dose to patients with difficult-to-heal venous leg ulcers.
- Trial name
- NCT05549609
- Testing
- XSTEM-VLU, Vehicle
- Where
- 2 sites in Sweden
- Volunteers
- 6 people
- Sponsor
- Xintela AB
Venous Leg Ulcers
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S.
- Trial name
- NCT01656889
- Testing
- HP-802-247, Vehicle
- Where
- 50 sites in United States, Canada
- Volunteers
- 447 people
- Sponsor
- Healthpoint
Wounds and Injuries, Burns
Clinical Registry Collecting Real World Evidence on Wound Care Treatments
The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.
- Conditions
- Wounds and Injuries, Burns, Mohs Surgery, Diabetic Foot Ulcer Mixed
- Trial name
- SIDDX (NCT06328010)
- Testing
- Various types of wound care treatments
- Where
- 12 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Siddhey LLC
Venous Leg Ulcer (VLU)
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system.
- Trial name
- NCT02167815
- Testing
- Mepilex XT, standard care
- Where
- 3 sites in Czechia
- Volunteers
- 30 people
- Sponsor
- Molnlycke Health Care AB
Non-Diabetic Patients, Wound Leg
Role of Tissue Oxygenation and the miR-210 Gene In Wound Healing
Hypothesis: Elevated miR210 in the epidermis (outer layer of skin) of ischemic human wound edge tissue (tissue that has a lack of blood flow to it) is associated with poor healing outcome in a setting of standard clinical care.
- Conditions
- Non-Diabetic Patients, Wound Leg, Chronic Ulcer Leg/Foot
- Trial name
- miR210 (NCT02024243)
- Where
- 3 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Chandan Sen
Venous Leg Ulcer
VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
- Trial name
- NCT02680834
- Testing
- Dual Action Pneumatic Compression Device, Multi-Layer Bandaging
- Where
- 18 sites in United States
- Volunteers
- 56 people
- Sponsor
- Tactile Medical
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer
CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations
CAMP RWE Trial: A Multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a tri-layer amnion graft or a single layer amnion graft to a coarsened exact matched retrospective control cohort of…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer, Wound; Foot
- Trial name
- CAMP RWE (NCT07046767)
- Testing
- IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap, IP2: BioLab Tri-Membrane Wrap
- Where
- 7 sites in United States
- Volunteers
- 165 people
- Sponsor
- Capsicure, LLC
Lower Extremity, Chronic Ulcers
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic lower extremity wounds.
- Conditions
- Lower Extremity, Chronic Ulcers, Pressure Ulcer (PU), Venous Leg Ulcer (VLU)
- Trial name
- NCT07862335
- Testing
- PRFM
- Volunteers
- 30 people
- Sponsor
- Tiger Biosciences, LLC.
Venous Leg Ulcer (VLU)
An Open Label, Single Treatment, Single Arm, Multiple Dose Phase-2 Study to Evaluate the Pharmacokinetics, Safety, and Clinical Performance of EscharEx (EX-03) in Participants With Venous Leg Ulcers
This is a pharmacokinetics (PK) study - the main objective of this study is to assess the PK, safety and clinical performance of 5% EscharEx (EX-03 formulation) in debridement of Venous Leg Ulcers
- Trial name
- NCT07692178
- Testing
- EX-03
- Volunteers
- 20 people
- Sponsor
- MediWound Ltd
Venous Leg Ulcer
Subjects With Non-Healing Venous Leg Ulcers Treated With Standard Care Plus Cryopreserved Human Umbilical Cord (TTAX01)
It is hypothesized that application at 4-week intervals of the human umbilical cord tissue TTAX01 to the surface of a well debrided, nonhealing venous leg ulcer (VLU) will result in a high proportion of wounds showing complete…
- Trial name
- NCT03818828
- Testing
- TTAX01, Profore Compression Therapy, Cadexomer Iodine dressing
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- BioTissue Holdings, Inc
Venous Leg Ulcer (VLU)
Observational Study Providing 12 Months of Safety Follow-Up From First Exposure to HP802-247
This observational safety follow-up study enrolled subjects from the 802-247-09-032 study with the investigational product HP802-247 for venous leg ulcers, who received at least one application of HP802-247 or Vehicle (Placebo).
- Trial name
- NCT01970657
- Testing
- No treatment specified, No treatment
- Where
- 43 sites in Belgium, Czechia and 3 more
- Volunteers
- 221 people
- Sponsor
- Healthpoint
Diabetic Foot Ulcer, Foot Ulcer Chronic
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…
- Conditions
- Diabetic Foot Ulcer, Foot Ulcer Chronic, DFU, Ulcer Foot
- Trial name
- BIORESCUE (NCT07364630)
- Testing
- Tri-Membrane Wrap™ DFU, Membrane Wrap™ DFU, Membrane Wrap-Lite™ DFU
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- BioLab Holdings
Venous Leg Ulcer (VLU), Venous Hypertension Ulcers
Effect of Photobiomodulation on Healing of Venous Leg Ulcers
Venous leg ulcers are a significant public health problem because of their prolonged duration, high recurrence rates, and economic, social, and quality-of-life effects.
- Conditions
- Venous Leg Ulcer (VLU), Venous Hypertension Ulcers, Chronic Venous Insufficiency, Chronic Venous Disease
- Trial name
- NCT07123285
- Testing
- Photobiomodulation Therapy, Compression Therapy
- Where
- Brazil
- Volunteers
- 102 people
- Sponsor
- University of Nove de Julho
Venous Leg Ulcer (VLU)
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.
- Trial name
- EVOLVE (NCT07230340)
- Testing
- Amnion-Intermediate-Chorion, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Cellution Biologics
Venous Leg Ulcer (VLU)
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).
- Trial name
- NCT07268482
- Testing
- A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
- Where
- Ireland
- Volunteers
- 40 people
- Sponsor
- Feeltect Limited
Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs)
HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU
This retrospective multi-site observational cohort study uses electronic health records (EHR) from U.S. wound care centers to evaluate the effectiveness of four amniotic membrane allografts (Acesso DL, Acesso TL, Neostim DL…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trial name
- HEAL-4 (NCT07223515)
- Where
- 2 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Dynamic Medical Services dba Acesso Biologics
Venous Leg Ulcer
A Study to Evaluate ENERGI-F703 GEL in Venous Leg Ulcer
This is a randomized, double-blind, placebo-controlled, phase II, multi-centered study to evaluate the efficacy and safety of ENERGI-F703 GEL in subjects who are ≥ 20 years old with venous leg ulcer (VLU).
- Trial name
- NCT04078555
- Testing
- ENERGI-F703 GEL, ENERGI-F703 GEL matched vehicle
- Where
- Taiwan
- Volunteers
- 80 people
- Sponsor
- Energenesis Biomedical Co., Ltd.
Venous Leg Ulcer (VLU), Compression Bandages
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.
- Trial name
- NCT07600489
- Testing
- Compression bandage system (Mepi™ Press 2), Compression bandage system (UrgoK2®), Wound Dressing Material
- Where
- 8 sites in France
- Volunteers
- 386 people
- Sponsor
- Molnlycke Health Care AB
Venous Leg Ulcers
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2
This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S.
- Trial name
- NCT01737762
- Testing
- HP802-247, Vehicle
- Where
- 43 sites in United States, Canada and 1 more
- Volunteers
- 155 people
- Sponsor
- Healthpoint
Venous Leg Ulcer, Leg Ulcer
Efficacy Study for Geko Device in VLU Patients (Canada)
The objective of this study is to compare the efficacy of a daily geko™ wound therapy (duration of 12 hours), in conjunction with standard of care (SC), to SC alone, in participants with venous leg ulcers.The participants will go…
- Conditions
- Venous Leg Ulcer, Leg Ulcer, Venous Ulcer
- Trial name
- NCT05057793
- Testing
- geko
- Where
- 3 sites in Canada
- Volunteers
- 2 people
- Sponsor
- Firstkind Ltd