Clinical trials: Cutaneous Ulcer Disease
Venous Leg Ulcer, Leg Ulcers Venous
Efficacy Study for Geko Device in VLU Patients
Eight weeks, comprised of four weeks Run-in Phase of Standard Care (SC) treatment followed by four weeks of treatment allocated by randomisation (Treatment Phase).
- Conditions
- Venous Leg Ulcer, Leg Ulcers Venous, Leg Ulcer, Wound Leg
- Trial name
- NCT03396731
- Testing
- geko™ medical device
- Where
- 23 sites in United Kingdom
- Volunteers
- 171 people
- Sponsor
- Firstkind Ltd
Venous Ulcer
Flexitouch Treatment for Venous Ulcers
This is a study to compare the healing process of venous stasis ulcers when the Flexitouch® system is added to the standard treatment of venous ulcers.
- Trial name
- NCT00847002
- Testing
- Standard Wound Care, Flexitouch System with Standard Wound Care
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Tactile Systems Technology, Inc.
Venous Leg Ulcer, Pressure Ulcer
Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in…
- Conditions
- Venous Leg Ulcer, Pressure Ulcer, Diabetic Foot Ulcer, Chronic Ulcer
- Trial name
- ASOLO-CW (NCT04753294)
- Testing
- Avance Solo NPWT System, Avance Solo Adapt NPWT System
- Where
- 13 sites in Belgium, Denmark and 5 more
- Volunteers
- 136 people
- Sponsor
- Molnlycke Health Care AB
Chronic Leg Ulcer, Venous Leg Ulcer
Safety and Tolerability of Single and Multiple Doses of SoftOx Biofilm Eradicator (SBE) in Chronic Leg Wounds
Single-centre clinical study investigating the safety and tolerability of randomised, double-blinded, placebo-controlled ascending single doses of topically applied SoftOx Biofilm Eradicator (SBE) in patients with chronic leg…
- Trial name
- NCT05710094
- Testing
- SoftOx Biofilm Eradicator (Groups 1 to 7), Sterile isotonic saline (Groups 1 to 4)
- Where
- Denmark
- Volunteers
- 28 people
- Sponsor
- SoftOx Solutions AS
Diabetic Foot Ulcer, Venous Ulcer
Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.
This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic neuropathic plantar and venous ulcers. HO/03/03 action mechanism involves the manipulation of keratinocyte and fibroblast migration and…
- Trial name
- NCT00338923
- Testing
- HO/03/03
- Where
- 3 sites in Israel
- Volunteers
- 22 people
- Sponsor
- HealOr
Pressure Ulcer
A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Pressure Ulcers
To assess the efficacy of the PRP Concepts Fibrin Bio-Matrix and compare its performance with usual and customary practice for the treatment of chronic non-healing pressure ulcers (PU).
- Trial name
- NCT02312570
- Testing
- PRP Concepts Fibrin Bio-Matrix, Usual and Customary Practice
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- PRP Concepts, LLC
Pressure Ulcer
A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
This study will be conducted in approximately 26 subjects in UK to yield 20 evaluable subjects at 3 sites with approximately 5-10 subjects/site.
- Trial name
- NCT01438541
- Testing
- Window
- Where
- 3 sites in United Kingdom
- Volunteers
- 29 people
- Sponsor
- Molnlycke Health Care AB
Pressure Ulcers, Venous Ulcers
Prospective PuraPly™ AM Case Series Study
The PuraPly AM case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylene biguanide hydrochloride (PHMB) and is intended for the…
- Conditions
- Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Surgical Wounds
- Trial name
- NCT03070925
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Organogenesis
Diabetic Foot
The Effects of BAY1193397 on Skin Capillary Blood Flow and Transcutaneous Oxygen Pressure
The purpose of the study is to analyse skin blood flow in diabetic patients. The patients receive a single dose of placebo, 1 mg BAY1193397, and 5 mg BAY1193397.
- Trial name
- NCT03128320
- Testing
- BAY1193397
- Where
- United Kingdom
- Volunteers
- 23 people
- Sponsor
- Bayer
Sickle Cell Disease, Leg Ulcers
Resolution of Sickle Cell Leg Ulcers With Voxelotor
This study is a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care for the treatment of leg ulcers in participants with sickle cell disease.
- Trial name
- RESOLVE (NCT05561140)
- Testing
- Voxelotor Oral Tablet
- Where
- 23 sites in Brazil, Kenya and 1 more
- Volunteers
- 88 people
- Sponsor
- Pfizer
Vascular Disease, Peripheral, Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics
The goal of this observational study is to learn if the measures of tissue oxygenation from the MIMOSA Pro imaging device correlate to standard vascular assessment tools in patients who receiving a lower extremity vascular…
- Trial name
- NCT06899113
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- MIMOSA Diagnostics Inc.
Venous Leg Ulcer
A Prospective Randomized, Double-Blind, Placebo-Controlled Trial Comparing VitroGro® ECM to Placebo in Patients With Venous Leg Ulcers
The objective of this study is to assess the efficacy and safety of VitroGro® combined with standard care in the treatment of Venous Leg Ulcers (VLUs) compared to Placebo with standard care over the course of the 8-week treatment…
- Trial name
- NCT01982318
- Testing
- VitroGro® ECM, Dulbecco's Phosphate Buffered Saline
- Sponsor
- Tissue Therapies Ltd.
Chronic Ulcer of Leg or Foot, Pressure Injury
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Dressings in the Management of Indicated Chronic Wound Types.
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ dressings in the management of indicated chronic wound types.
- Trial name
- MORGEN (NCT05632250)
- Testing
- ConvaFoam
- Where
- 5 sites in United States
- Volunteers
- 95 people
- Sponsor
- ConvaTec Inc.
Venous Stasis Ulcers
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers
- Trial name
- SSVS (NCT00832091)
- Testing
- Thymosin Beta 4
- Where
- 8 sites in Italy, Poland
- Volunteers
- 72 people
- Sponsor
- RegeneRx Biopharmaceuticals, Inc.
Pressure Injury
Prevention of Pressure Ulcers in Patients at Medium to High Risk of Developing Pressure Ulcers and Using the DOMUS 4 / AUTO Motorized Air Mattress
The aim of the study is to determine the clinical value of using a powered alternating pressure air mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk.
- Trial name
- NCT05472974
- Testing
- Use of a powered alternating pressure air mattress
- Where
- 5 sites in France
- Volunteers
- 86 people
- Sponsor
- Wellell France
Pressure Ulcer
Study of SANTYL® vs Hydrogel (SoloSite®) for Pressure Ulcers
This study is designed to compare SANTYL® versus hydrogel (SoloSite®) in the treatment of pressure ulcers for participants in a long-term care facility.
- Trial name
- NCT02718625
- Testing
- Santyl, SoloSite®
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-101 Clinical Trial
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.
- Trial name
- NCT03183726
- Testing
- ALLO-ASC-DFU
- Volunteers
- 4 people
- Sponsor
- Anterogen Co., Ltd.
Respiratory Failure
Prevention of Pressure Ulcers in Patients Under Non-Invasive Mechanical Ventilation
This study aims to test direct application of the Non-Invasive Mechanical Ventilation -NIVM- mask or interface as the most efficient intervention to prevent Pressure Ulcers (PU), compared with other three usual preventive…
- Trial name
- PUPPVMNI (NCT02526862)
- Testing
- Allevyn Thin®, Askina Transorbent Border®, Linovera®
- Where
- Spain
- Volunteers
- 152 people
- Sponsor
- B. Braun Medical SA
Venous Leg Ulcer
Intermittent Pneumatic Compression of the Foot vs Geko Plus R-2 Neuromuscular Electrostimulation Device in Venous Leg Ulcer Patients
Chronic venous leg ulcers (VLU) are painful, debilitating wounds that place a significant burden on the patient, their family, and healthcare resources.
- Trial name
- NCT02912858
- Testing
- geko plus R-2
- Sponsor
- Firstkind Ltd
Diabetic Foot Ulcer, Venous Leg Ulcer
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.
- Trial name
- NCT06236750
- Testing
- EPIFIX
- Where
- 5 sites in Japan
- Volunteers
- 75 people
- Sponsor
- MiMedx Group, Inc.