Clinical trials: Leg Ulcer
Venous Leg Ulcer (VLU)
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…
- Trial name
- NCT07440797
- Testing
- Saline solution, Vashe solution
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Laboratoires URGO
Venous Leg Ulcers, Venous Leg Ulcers (VLUs)
Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal VLUs
The purpose of this study is to evaluate the efficacy of two dehydrated human umbilical cord-based medical devices, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in…
- Conditions
- Venous Leg Ulcers, Venous Leg Ulcers (VLUs), Venous Leg, Leg Ulcers
- Trial name
- CORDSTIM-VLU (NCT07449988)
- Testing
- Standard of Care (SOC), Corplex P, Theracor
- Volunteers
- 272 people
- Sponsor
- StimLabs
Diabetic Foot Ulcer, Venous Leg Ulcer
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
- Trial name
- NCT04927702
- Testing
- Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Acera Surgical, Inc.
Venous Leg Ulcers, Mixed Ulcer
Chemical Debridement and Leg Ulcers
A pilot study to investigate the relative effectiveness and safety of chemical wound debridement and curettage in the treatment of venous and mixed aetiology leg ulcers.
- Trial name
- NCT06652360
- Testing
- Chemical Debridement, Curettage debridement
- Where
- United Kingdom
- Volunteers
- 80 people
- Sponsor
- DEBx Medical B.V.
Chronic Venous Insufficiency, CVI, Venous Malformations
Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery
The goal of this clinical trial is to learn if the Sonablate High Intensity Focused Ultrasound device can be safely used to treat patients with Chronic Venous Incompetence (CVI) including those with venous malformations of the…
- Conditions
- Chronic Venous Insufficiency, CVI, Venous Malformations, Venous Leg Ulcers, Klippel-Trenaunay Syndrome
- Trial name
- HIFIVE (NCT06642051)
- Testing
- High Intensity focused ultrasound
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Sonablate
Venous Leg Ulcer, Venous Ulcer
Tissue Repair Gel in Venous Leg Ulcers (US)
The goal of this clinical trial is to learn if TR987 0.1% gel + Standard of Care works better than Standard of Care alone to treat Venous Leg Ulcers (VLUs).
- Conditions
- Venous Leg Ulcer, Venous Ulcer, Venous Stasis Ulcer, Venous Stasis
- Trial name
- TRIVIA (NCT06707090)
- Testing
- TR987 0.1% gel + Standard of Care, Standard of care
- Where
- 33 sites in United States
- Volunteers
- 312 people
- Sponsor
- TR Therapeutics
Wound Healing, Diabetic Foot
Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™
Study will evaluate the performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with Symphony™ in the treatment of chronic non-healing diabetic foot ulcers after 12 weeks of treatment.
- Conditions
- Wound Healing, Diabetic Foot, Chronic Foot Ulcer, Foot Ulcer
- Trial name
- NCT06035523
- Testing
- Endoform™ Antibacterial, Endoform™ Natural, Symphony™
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- Aroa Biosurgery Limited
Diabetic Foot, Diabetic Foot Ulcer
Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC) in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Chronic Foot Ulcer
- Trial name
- NCT06035536
- Testing
- Symphony™ plus Off-loading, Wound Dressing comprising of calcium alginate Fibracol
- Where
- 11 sites in United States
- Volunteers
- 143 people
- Sponsor
- Aroa Biosurgery Limited
Venous Insufficiency, Venous Leg Ulcer
PICO Venous Leg Ulcers (VLU) Reimbursement Study
This study intends to demonstrate the superiority of PICO treatment when applied up to 12 weeks, versus Standard of Care (SOC) in the treatment of hard to heal Venous Leg Ulcers (VLU) by community-based practitioners.
- Trial name
- NCT06510777
- Testing
- PICO Treatment, Standard of Care (SOC) Treatment
- Where
- 44 sites in France
- Volunteers
- 142 people
- Sponsor
- Smith & Nephew, Inc.
Venous Leg Ulcer, Diabetic Foot
AQUACEL® Ag+ Extra™ vs Cutimed® Sorbact®
Study is to provide a blinded assessment of wound closure status utilizing photographs collected as per standard of care (SOC) during the AAA RCT (WC-22-435).
- Trial name
- NCT07308678
- Where
- Germany
- Volunteers
- 105 people
- Sponsor
- ConvaTec Inc.
Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs)
Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting.
- Conditions
- Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Pressure Ulcers, Surgical Wound Dehiscence (SWD)
- Trial name
- NCT06939673
- Testing
- Acellular Porcine-Derived Wound Matrix
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Reprise Biomedical, Inc.
Diabetic Foot Ulcers (DFUs), Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared to SOC alone in treating Wagner Grade 1 diabetic foot ulcers (DFUs) and…
- Trial name
- STRIDDDE (NCT06939686)
- Testing
- Miro3D Wound Matrix, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Reprise Biomedical, Inc.
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
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…
- Trial name
- NCT07172893
- Testing
- DermaBind TL
- Where
- 10 sites in United States
- Volunteers
- 150 people
- Sponsor
- HealthTech Wound Care
Diabetic Foot Ulcer, Venous Leg Ulcer
The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds
This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers.
- Trial name
- SPACE (NCT05666570)
- Testing
- Avelle NPWT
- Where
- Colombia
- Sponsor
- ConvaTec Inc.
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
Venous Leg Ulcer, Diabetic Foot
AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period
Study is to provide evidence comparing AQUACEL® Ag+ Extra™ versus Cutimed® Sorbact® in the progression of wounds towards healing
- Trial name
- NCT05892341
- Testing
- AQUACEL® Ag+ Extra™, Cutimed® Sorbact®
- Where
- 18 sites in Colombia, Germany and 1 more
- Volunteers
- 203 people
- Sponsor
- ConvaTec Inc.
Venous Leg Ulcer (VLU)
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.
- Trial name
- VaLUe I (NCT06754735)
- Testing
- Topical Wound Oxygen Therapy
- Where
- United States
- Volunteers
- 212 people
- Sponsor
- AOTI Ltd.
Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs)
Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU
This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone.
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trial name
- NCT07223281
- Where
- 4 sites in United States
- Volunteers
- 2,400 people
- Sponsor
- Legacy Medical Consultants
Chronic Wounds, Venous Leg Ulcers (VLUs)
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic wounds constitute a significant global health burden, affecting millions of individuals and contributing to increased morbidity, diminished quality of life, and rising healthcare costs.
- Conditions
- Chronic Wounds, Venous Leg Ulcers (VLUs), Diabetic Foot Ulcers (DFUs), Arterial Ulcers
- Trial name
- NCT07223892
- Testing
- Amniotic Tissue Allograft
- Volunteers
- 600 people
- Sponsor
- Bardia Anvar
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