Clinical trials: Venous Ulcer of Leg
Venous Leg Ulcers, Diabetic Foot Ulcers
Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)
The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.
- Trial name
- NPWT (NCT02470806)
- Testing
- PICO System, tNPWT System
- Where
- 17 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Smith & Nephew, Inc.
Venous Leg Ulcer, Diabetic Foot Ulcer
A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers
This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU).
- Trial name
- NCT04817228
- Testing
- EscharEx (EX-02 formulation)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- MediWound Ltd
Wound Infection, Wound Heal
Analytical Performance of pH, HNE and MPO Levels in Detecting Wound Infection Proof of Concept Biomarker Study
The purpose of this study is to evaluate the effectiveness of a novel combination of biomarkers, pH/HNE/MPO, in detecting wound infection using the clinical judgement at 4 weeks as a standard of reference which will include a…
- Trial name
- INDICATE (NCT04979637)
- Sponsor
- ConvaTec Inc.
Impaired Wound Healing
A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers
This study is designed to demonstrate the outcome of complete ulcer closure of patients with Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary Care (UCC).
- Trial name
- NCT02248077
- Testing
- AutoloGel, Usual and Customary Care (UCC)
- Sponsor
- Cytomedix
Venous Ulcer, Infection
Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers
Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following…
- Trial name
- NCT01396304
- Testing
- Restore Calcium Alginate Dressing, AquaCel Ag Wound Dressing
- Where
- 5 sites in United States
- Volunteers
- 19 people
- Sponsor
- Hollister Wound Care LLC
Wound Heal, Venous Leg Ulcer
INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone
INNOVEN is a multi-center randomized controlled clinical trial to evaluate the efficacy of porcine placental extracellular matrix (PPECM) and standard of care (SOC) versus SOC alone in the closure of non-healing venous leg ulcers…
- Trial name
- NCT06606210
- Testing
- InnovaMatrix® AC
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- ConvaTec Inc.
Leg Ulcer
Study to Evaluate the Performance of AQUACEL® Extra™ in Venous Leg Ulcers
Based upon the in-vitro data AQUACEL® Extra™ achieves a 39% increase in absorbency. As such it is anticipated that through improved exudate management a longer wear time will be achieved in the AQUACEL® Extra™ group compared to…
- Trial name
- NCT01591434
- Testing
- AQUACEL®, AQUACEL® Extra™
- Where
- 12 sites in Germany, Netherlands and 2 more
- Volunteers
- 65 people
- Sponsor
- ConvaTec Inc.
Skin Ulcer Venous Stasis Chronic
Allogeneic ABCB5-positive Stem Cells for Treatment of CVU
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction of Chronic Venous Ulcers) and safety (by monitoring adverse events) of the medicinal product to be studied after two…
- Trial name
- NCT03257098
- Testing
- allo-APZ2-CVU
- Where
- 9 sites in Germany
- Volunteers
- 31 people
- Sponsor
- RHEACELL GmbH & Co. KG
Wounds, Other Ulcers Wounds and Skin Problems
Safety and Efficacy of Topical AR/101 Compared With Placebo, in Accelerating Granulation Tissue Formation of Hard-to-heal Wounds
This prospective, placebo-controlled, double blind, randomized study is designed to assess the healing effects of AR/101 on chronic Hard-to-Heal wound(s) of different etiologies including arterial ulcers, diabetic ulcers and…
- Trial name
- NCT02839226
- Testing
- AR/101
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- Arava Bio Tech Ltd.
Varicose Veins, Veins Diseases
Treatment of Insufficient Superficial and Perforatring Veins of the Lower Limb Using HIFU
This is a one-arm, open label, prospective, single center study to evaluate clinical standardization with Theraclion's Sonovein 2 HIFU device.
- Conditions
- Varicose Veins, Veins Diseases, Varicose Ulcer
- Trial name
- NCT04280679
- Testing
- Sonovein 2
- Where
- Austria
- Volunteers
- 22 people
- Sponsor
- Theraclion
Diabetic Foot Ulcer, Venous Leg Ulcer
Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers
The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot and…
- Trial name
- CAMPLIFE (NCT06562296)
- Testing
- Amnion-Intermediate-Chorion, Amnion-Chorion-Amnion, Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 292 people
- Sponsor
- Cellution Biologics
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
Wounds, Wound of Skin
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up.
- Conditions
- Wounds, Wound of Skin, Wound Leg, Wound; Foot
- Trial name
- NCT05588583
- Testing
- Mepilex Up
- Where
- 4 sites in United States
- Volunteers
- 68 people
- Sponsor
- Molnlycke Health Care AB
Leg Ulcer, Varicose Ulcer
Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.
- Trial name
- NCT00399308
- Testing
- Celaderm (Frozen Cultured Epidermal Allograft), Control (compression bandaging)
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Shire
Skin Ulcer
Bio-ConneKt Wound Dressing for Treatment of Chronic Leg Wounds: A Pilot Study
The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers…
- Trial name
- NCT02309684
- Volunteers
- 20 people
- Sponsor
- MLM Biologics Inc.,
Leg Ulcer
A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers
This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on venous leg ulcers.
- Trial name
- NCT00235209
- Testing
- Collagen ORC Antimicrobial Matrix (CAM)
- Where
- 3 sites in United States
- Volunteers
- 48 people
- Sponsor
- Ethicon, 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.
Venous Leg Ulcer
Management of Infection Risk in Non-comparative Trial (MINT)
The URGO2875 dressing is an innovative antimicrobial dressing made of exclusive technologies of TLC-Ag healing matrix and fibres.
- Trial name
- MINT (NCT03670329)
- Testing
- URGO2875
- Volunteers
- 50 people
- Sponsor
- Laboratoires URGO
Venous Leg Ulcer
A Study to Evaluate the Safety and the Efficacy of EscharEx (EX-02 Formulation) in Debridement of Venous Leg Ulcers
This study is a multicenter, prospective, randomized, placebo controlled, adaptive design study performed to assess the safety and the efficacy of 5% EscharEx (EX-02) compared to Gel Vehicle (placebo) and non-surgical standard of…
- Trial name
- NCT03588130
- Testing
- EscharEx (5% EX-02 formulation), Gel Vehicle, Non-surgical standard of care (NSSOC)
- Where
- 22 sites in United States, Switzerland
- Volunteers
- 120 people
- Sponsor
- MediWound Ltd
Venous Leg Ulcer
Investigation of the Clinical Performance of Biatain Fiber Ag on Venous Leg Ulcers
The goal of this study is to test a new gelling fiber wound dressing with silver on patients with a venous leg ulcer Participants will be asked to wear the test dressing in a four weeks period (+/- 2 days) consisting of 6 study…
- Trial name
- NCT05873257
- Testing
- Biatain Fiber Ag applied to participants
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Coloplast A/S