Clinical trials: Venous Leg Ulcers
Venous Leg Ulcer (VLU), Diabetic Foot Ulcer (DFU)
Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound Management
The purpose of this single arm clinical study is to find out how well two Silicone superabsorbent polymer dressings, RespoSorb Silicone (also known as Zetuvit Plus Silicone) and RespoSorb Silicone Border (also known as Zetuvit…
- Trial name
- NCT07549737
- Testing
- RespoSorb Silicone (RSSil), RespoSorb Silicone Border (RSSB)
- Where
- 8 sites in Poland
- Volunteers
- 80 people
- Sponsor
- HARTMANN GROUP
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
PAW-Hydrogel for Chronic Wound Healing
The goal of this randomized controlled trial is to evaluate the efficacy and safety of a novel hydrogel made of Carbopol® 940 functionalized with Plasma-Activated Water (PAW) in patients with chronic wounds (diabetic foot ulcers…
- Conditions
- Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU), Wound Dehiscence, Venous Leg Ulcer
- Trial name
- NCT07541196
- Testing
- PAW-Functionalized Carbopol® 940 Hydrogel, Standard Advanced Wound Care
- Where
- Mexico
- Volunteers
- 50 people
- Sponsor
- Benjamín Gonzalo Rodríguez Méndez
Venous Leg Ulcer
Diagnostics in the Leg Ulcer Pathway
This project aims to investigate 'The minimum diagnostic requirements for patients presenting to primary care with suspected venous ulcers.' In order to do this, the investigators intend to run a series of questionnaires with…
- Trial name
- NCT06181708
- Testing
- N/A - Questionnaire based study
- Where
- United Kingdom
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer
MAtrix Therapy for Hard-to-heal ChrOnic Wounds
CACIPLIQ20® is currently a class III CE marked medical device available in various European and non-European countries, and currently primarily used in managing hard-to-heal wounds.
- Conditions
- Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer, Arterial Ulcer, Venous Ulcer of Leg
- Trial name
- MATHCOW (NCT05170984)
- Testing
- CACIPLIQ20®
- Where
- France
- Volunteers
- 191 people
- Sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
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 Ulcer
Evaluating the Efficacy of NeoThelium FT in the Treatment of Venous Leg Ulcers
This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating venous leg ulcers.
- Trial name
- NCT06930768
- Testing
- Standard of Care, NeoThelium FT
- Volunteers
- 132 people
- Sponsor
- NuScience Medical Biologics, LLC
Hard-to-heal Wounds, Venous Leg Ulcer (VLU)
Laser Photobiomodulation for Hard-to-heal Ulcers in Frail Older Adults
The aim of this quasi-experimental prospective study is to evaluate the effectiveness of photobiomodulation treatment on hard-to-heal ulcers of various diagnosed aetiologies in frail older adults, admitted to municipal home…
- Conditions
- Hard-to-heal Wounds, Venous Leg Ulcer (VLU), Arterial Leg Ulcer, Pressure Ulcer (PU)
- Trial name
- NCT07520825
- Testing
- Photobiomodulation, Standard-of-care ulcer dressing
- Where
- Sweden
- Volunteers
- 1,290 people
- Sponsor
- Umeå University
Diabetic Foot Ulcer, Venous Leg Ulcer
Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, and to compare Sanograft to standard of care in treating venous leg ulcers.
- Trial name
- NCT06515093
- Testing
- PelloGraft, SanoGraft
- Where
- 2 sites in United States
- Volunteers
- 180 people
- Sponsor
- Surgenex
Venous Leg Ulcers
Clinical Trial Evaluating NuShield® Plus Standard of Care (SOC) Versus Standard of Care (SOC) Alone in the Management of Non-Healing Venous Leg Ulcers (VLUs)
A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® plus Standard of Care (SOC) versus Standard of Care (SOC) alone in the Management of Non-Healing Venous Leg Ulcers (VLUs).
- Trial name
- NCT07510412
- Testing
- NuShield®
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Organogenesis
Venous Leg Ulcer
Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers
This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.
- Trial name
- NCT07211243
- Testing
- PHMB-impregnated biocellulose wound dressing with additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional), PHMB-impregnated biocellulose wound dressing without additional polyethylene film on top, compression therapy, systemic antomicrobial therapy (optional)
- Where
- 9 sites in Poland
- Volunteers
- 150 people
- Sponsor
- Lohmann & Rauscher
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)
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
Deep Vein Thrombosis, Venous Stasis
Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)
The purpose of this study is to determine if the use of image-guided, endovascular therapy (EVT) is an effective strategy with which to reduce Post Thrombotic Syndrome (PTS) disease severity and improve quality of life in…
- Conditions
- Deep Vein Thrombosis, Venous Stasis, Venous Insufficiency, Venous Leg Ulcer
- Trial name
- C-TRACT (NCT03250247)
- Testing
- Stents
- Where
- 29 sites in United States
- Volunteers
- 225 people
- Sponsor
- Washington University School of Medicine
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.