Clinical trials: Ulcer, Leg
Venous Leg Ulcers
The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers
The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, compression therapy alone for the treatment of venous leg ulcers.
- Trial name
- NCT00953563
- Testing
- Unite Biomatrix
- Where
- 3 sites in United States
- Sponsor
- Baxter Healthcare Corporation
Diabetic Foot Ulcer
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™).
- Trial name
- NCT03312595
- Testing
- Restrata TM Wound Matrix
- Where
- 5 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acera Surgical, Inc.
Diabetic Foot Ulcers (DFUs)
Clinical Trial Evaluating an Amnion Membrane Allograft for Use in the Management of Non- Healing Diabetic Foot Ulcers Versus Standard Of Care
The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with Standard of Care (SOC) versus FIBRACOL™ with SOC.
- Trial name
- NCT06767501
- Testing
- E-GRAFT ™, FIBRACOL™
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Skye Biologics Holdings, LLC
Diabetic Foot Ulcers
Safety Study of Topical Human FGF-1 for Wound Healing
The purpose of the study is to see if FGF-1 is safe when applied topically to the surface of a wound.
- Trial name
- NCT00916292
- Testing
- FGF-1 141
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Phage Pharmaceuticals, Inc.
Diabetic Foot Ulcer
AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers
This is a prospective, multicenter, randomized, parallel-group Trial comparing the outcomes associated with the use of AmnioExcel® Plus Placental Allograft Membrane (AmnioExcel® Plus) used in conjunction with Standard of Care…
- Trial name
- NCT05024656
- Testing
- AmnioExcel Plus Amniotic Membrane, Standard of Care
- Sponsor
- Integra LifeSciences Corporation
Foot Ulcer, Diabetic, Infection
Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer.
- Trial name
- COACT-1 (NCT02427802)
- Testing
- Gentamicin collagen sponge
- Where
- 86 sites in United States
- Volunteers
- 612 people
- Sponsor
- Innocoll
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
Diabetic Foot Ulcers
TITLE: An Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU, When Using Mepilex Transfer Ag as Intended
An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer Ag as intended.
- Trial name
- MxT Ag 05 (NCT01964521)
- Testing
- Mepilex Transfer Ag
- Where
- 2 sites in United Kingdom
- Volunteers
- 24 people
- Sponsor
- Molnlycke Health Care AB
Venous Ulcers
Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers
This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers
- Trial name
- NCT00545298
- Testing
- Nitric Oxide - same dose 6 wks, Nitric Oxide modified treatment
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Nitric BioTherapeutics, Inc
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
Diabetic Foot Ulcers
Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Wound Therapy
The study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.
- Trial name
- NCT00847730
- Testing
- V.A.C. Negative Pressure Wound Therapy System
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- KCI USA, Inc
Ulcer, Venous Ulcer
ECM and Blood Components for Wound Healing
The Extracellular Matrix (ECM) and Blood Components for Wound Healing feasibility study is a clinical trial approved by Health Canada to study the safety of extracellular matrix (ECM) and autologous blood products in wound…
- Conditions
- Ulcer, Venous Ulcer, Foot Ulcer, Diabetic
- Trial name
- NCT01909908
- Testing
- ECM, Blood Products, ECM in Blood Products
- Where
- Canada
- Volunteers
- 2 people
- Sponsor
- Cook Group Incorporated
Diabetic Foot, Chronic Ulcer
Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUs
The study is a multi-center, prospective, randomized, controlled, single blinded clinical study consisting of 150 subjects from up to 20 centers.
- Trial name
- NCT04185558
- Testing
- ActiGraft, Standard of Care
- Where
- 16 sites in United States, South Africa and 1 more
- Volunteers
- 119 people
- Sponsor
- RedDress Ltd.
Diabetic Foot Ulcer, Mesenchymal Stromal Cells
Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients.
The STEMFOOT Pilot Study is a single center randomized open phase I clinical intervention pilot trial with the aim of investigating the treatment effect of an allogenic adipose-derived mesenchymal stromal cell product (C2C_ASC)…
- Trial name
- STEMFOOT (NCT05595681)
- Testing
- Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®)
- Where
- Denmark
- Volunteers
- 21 people
- Sponsor
- Cell to Cure ApS
Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection
Myriad™ Augmented Soft Tissue Reconstruction Registry
This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures.
- Conditions
- Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection, Lower Extremity Wound, Pilonidal Sinus
- Trial name
- MASTRR (NCT05243966)
- Testing
- Myriad Matrix™ and Myriad Morcells™
- Where
- 15 sites in United States
- Volunteers
- 800 people
- Sponsor
- Aroa Biosurgery Limited
Foot Ulcer, Diabetic
Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections
To compare the rates of clinical success of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in subjects with mild diabetic foot infections in non-ischemic ulcers.
- Trial name
- NCT00516958
- Testing
- Topical Dermacyn, Topical Dermacyn and Levofloxacin, Topical Saline and Levofloxacin
- Where
- 16 sites in United States
- Volunteers
- 65 people
- Sponsor
- Oculus Innovative Sciences, Inc.
Leg Ulcer
EASH Dressing on Chronic Venous Leg Ulcers
The primary objective of this study is to evaluate the safety and preliminary performance of EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.
- Trial name
- NCT01497210
- Testing
- EASH dressing
- Where
- 6 sites in Poland, United Kingdom
- Volunteers
- 40 people
- Sponsor
- ConvaTec Inc.
Diabetic Foot Ulcers
Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers
The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers.
- Trial name
- DFU (NCT01596920)
- Testing
- Tissue, Control
- Where
- 15 sites in United States
- Volunteers
- 97 people
- Sponsor
- Osiris Therapeutics
Diabetic Foot Ulcers
Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.
- Trial name
- NCT01353495
- Testing
- APM Graft (BIOTAPE XMTM), Wound Debridement
- Where
- 2 sites in United States
- Volunteers
- 39 people
- Sponsor
- Stryker Trauma and Extremities
Venous Leg Ulcer
Dose-response Relationship Study of S42909 on Leg Ulcer Healing
Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer.
- Trial name
- NCT03077165
- Testing
- S42909 100 mg, S42909 200 mg, S42909 400 mg
- Where
- 80 sites in United States, Argentina and 9 more
- Volunteers
- 121 people
- Sponsor
- Ilkos Therapeutic Inc.