Clinical trials: Chronic Ulcers of the Lower Limb
Venous Ulcer, Venous Stasis Ulcer
Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic 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.
- Conditions
- Venous Ulcer, Venous Stasis Ulcer, Ulcer
- Trial name
- NCT01853384
- Testing
- HP802-247, HP802-247 Vehicle
- Where
- 46 sites in Belgium, Czechia and 3 more
- Volunteers
- 252 people
- Sponsor
- Healthpoint
Diabetes Mellitus, Chronic Ulcers of the Lower Limb
Hyperbaric Oxygen Therapy (HBOT) for Chronic Diabetic Lower Limb Ulcers
The purpose of this study is to determine if HBOT plus standard wound care is more effective than standard wound care alone at preventing the need for major amputation (metatarsal and up) in patients with diabetes mellitus (Type…
- Trial name
- HBOT (NCT00621608)
- Testing
- Hyperbaric Oxygen Therapy
- Where
- Canada
- Volunteers
- 107 people
- Sponsor
- St. Joseph's Healthcare Hamilton
Acute and Chronic Wounds, Pressure Ulcers
Clinical Evaluation of the SNaP Wound Care System
The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of…
- Conditions
- Acute and Chronic Wounds, Pressure Ulcers, Trauma Wounds, Diabetic Foot Ulcers
- Trial name
- NCT01113658
- Testing
- SNaP Wound Care System
- Where
- 2 sites in United States
- Sponsor
- 3M
Venous Ulcer, Allograft
Decellularised Dermis Allograft for the Treatment of Chronic Venous Leg Ulceration
Does the use of decellularised dermis allograft in addition to compression therapy promote healing in chronic venous leg ulceration compared to compression therapy alone
- Trial name
- DAVE (NCT04021316)
- Testing
- dCELL® Human Dermis (decellularised dermal skin allograft - DCD), Compression bandaging therapy
- Where
- 17 sites in United Kingdom
- Volunteers
- 71 people
- Sponsor
- Imperial College London
Pressure Ulcer, Diabetic Foot Ulcer
An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fiber Silver Dressing, When Used in Medium to High Exuding Chronic Wounds
An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds
- Conditions
- Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
- Trial name
- NCT05494450
- Testing
- ExufiberAG+
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer
A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
This prospective, multi-center, randomized, controlled modified platform Trial compares Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care versus…
- Trial name
- PREPARE (NCT06618612)
- Testing
- Standard of Care, PuraPly AM, PuraPly XT
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Organogenesis
Lower Extremity Chronic Venous Ulcers
Assessment of the Safety and Efficacy of DERMASTREAM™ - ENZYSTREAM™ System for the Treatment of Chronic Venous Ulcers
The study objectives are to evaluate DermastreamTM - EnzystreamTM system safety, tolerability and efficacy, as a potent method for debridement of nonhealing lower extremity chronic venous ulcers patients.
- Trial name
- ENZ-DER-002-IL (NCT00485329)
- Testing
- Papain
- Where
- 3 sites in Israel
- Volunteers
- 48 people
- Sponsor
- EnzySurge
Chronic Cutaneous Ulcer, Sickle Cell Disease
Deferoxamine for Sickle Cell Chronic Leg Ulcer Treatment
Approximately 60 subjects will be enrolled into this double-blind, placebo-controlled study for the Deferoxamine Intradermal Delivery Patch (DIDP).
- Trial name
- D-SCOUT (NCT04058197)
- Testing
- Deferoxamine Product
- Where
- 4 sites in United States
- Sponsor
- TauTona Group
Diabetic Foot Ulcer
DermACELL in Subjects With Chronic Wounds of the Lower Extremities
The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
- Trial name
- NCT01970163
- Testing
- DermACELL, GraftJacket, Conventional Care Dressings
- Where
- 12 sites in United States
- Volunteers
- 202 people
- Sponsor
- LifeNet Health
Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer), Chronic Wound Care
Clinical Performance of ComBatic™ Antimicrobial Wound Care Products in Hard-to-Heal Wounds
The goal of this clinical trial is To assess the feasibility of delivering the study protocol in adults with chronic, hard-to-heal lower leg wounds.
- Trial name
- COMBAT-H (NCT07872930)
- Testing
- Irrigation Solution for wounds, Hydrogel for wound care
- Volunteers
- 96 people
- Sponsor
- University of Calgary
Ulcus Cruris
Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds
This is a randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. The study will be conducted at a single center with a total of 70 patients.
- Trial name
- NCT01434914
- Testing
- octenisept®
- Where
- Germany
- Volunteers
- 9 people
- Sponsor
- Schülke & Mayr GmbH
Diabetic Foot Ulcers
Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers
The primary goal of the study is to demonstrate the increased rate of complete wound closure by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers
- Trial name
- NCT02209051
- Testing
- AMNIOEXCEL, Standard of Care, Diabetic Foot Ulcers
- Where
- 8 sites in United States
- Volunteers
- 29 people
- Sponsor
- Integra LifeSciences Corporation
Foot Ulcer, Diabetic
Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix
The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without…
- Trial name
- HEALED (NCT01729286)
- Testing
- PriMatrix Moist Wound Therapy, Standard of Care Moist Wound Therapy
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 92 people
- Sponsor
- Integra LifeSciences Corporation
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
Leg Ulcer
A Randomised Controlled Trial Comparing Vacuum Assisted Closure (V.A.C.®) With Modern Wound Dressings
Current treatment modalities for chronic leg ulcers are time consuming, expensive, and only moderately successful. Recent data suggest that creating a sub-atmospheric pressure by Vacuum Assisted Closure (V.A.C.®) therapy supports…
- Trial name
- NCT00243620
- Testing
- Vacuum therapy (device)
- Where
- Netherlands
- Volunteers
- 60 people
- Sponsor
- Maastricht University Medical Center
Pressure Injury, Venous Leg Ulcer
Pivotal Study of an Antimicrobial Wound Dressing to Treat Chronic Wounds
The goal of this clinical trial is to assess the impact that the NanoSALV wound dressing can have on managing severe chronic wounds and feasibility for patients, providers, and health systems in different health care settings…
- Conditions
- Pressure Injury, Venous Leg Ulcer, Pressure Injury Stage 2, Pressure Injury Stage III
- Trial name
- NCT05619237
- Testing
- NanoSALV Catalytic
- Where
- 4 sites in Canada
- Volunteers
- 44 people
- Sponsor
- Chester Ho, MD
Venous Reflux
VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous…
- Trial name
- NCT03820947
- Testing
- VenaSeal™ System, Endothermal Ablation (ETA), Surgical Stripping
- Where
- 32 sites in United States, Australia and 8 more
- Volunteers
- 506 people
- Sponsor
- Medtronic Endovascular
Diabetic Foot Ulcer
Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers.
- Trial name
- TWO2DFU (NCT02326337)
- Testing
- TWO2 Device
- Where
- 17 sites in United States, France and 3 more
- Volunteers
- 73 people
- Sponsor
- AOTI Ltd.
Leg Ulcer
Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs
In this open study, the primary objective is to study the efficacy and clinical outcome of the chronic wounds treated with this preparation for 8 weeks on 30 adults.
- Trial name
- NCT01111695
- Testing
- ApisSept
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- University Hospital, Geneva
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
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…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU), Pressure Ulcer (PU)
- Trial name
- RETRO-PLAST (NCT07375160)
- Testing
- dHPT, AIC
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Cellution Biologics