Clinical trials: Chronic Leg Ulcer
Chronic Leg Ulcer, Chronic Diabetic Foot Ulcer
A PMCF Investigation on Chronic LU and DFU in Need of Debridement With ChloraSolv®
This is a single-arm, observational, multicenter PMCF investigation designed to confirm clinical performance and safety of ChloraSolv when exposed to larger population of clinical users.
- Trial name
- ChloraSolv02 (NCT04838600)
- Testing
- ChloraSolv
- Where
- 7 sites in Sweden
- Volunteers
- 34 people
- Sponsor
- RLS Global
Chronic Leg Ulcer
Oxygen Wound Therapy Feasibility Study
Determine the feasibility of using a new topical oxygen therapy device to treat hard to heal lower leg wounds.
- Trial name
- NCT05422248
- Testing
- Series Topical Oxygen Therapy, Paired Topical Oxygen Therapy
- Where
- New Zealand
- Volunteers
- 10 people
- Sponsor
- Fisher and Paykel Healthcare
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
Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease
Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor [HGF] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.
- Conditions
- Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia, Ischemic Ulcer of Foot
- Trial name
- NCT04267640
- Testing
- AMG0001
- Where
- 20 sites in United States
- Volunteers
- 60 people
- Sponsor
- AnGes USA, Inc.
Chronic Ulcer at Lower Leg
An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds
The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 moth) lower leg ulcer.
- Trial name
- NCT03808181
- Testing
- ChloraSolv
- Where
- 9 sites in Sweden
- Volunteers
- 59 people
- Sponsor
- RLS Global
Chronic Wound, Venous Leg Ulcer
Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.
- Conditions
- Chronic Wound, Venous Leg Ulcer, Diabetic Foot Ulcer
- Trial name
- NCT03662997
- Testing
- Bordered Five-Layer Foam Dressing, Hydropolymer Foam Dressing, Hydrocellular Multi-Layer Foam Dressing
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Molnlycke Health Care AB
Skin Ulcer Venous Stasis Chronic, Mixed Arteriovenous Leg Ulcer
Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers
The purpose of this study is to determine the effectiveness of the NatroxTM Topical Oxygen device versus a placebo in patients with non-healing leg ulceration in conjunction with standard best practice.
- Trial name
- NCT01913704
- Testing
- NatroxTM Device
- Where
- 2 sites in Czechia
- Sponsor
- Inotec AMD Limited
Wound, Chronic Leg Ulcer
Positive Predictive Value (PPV) of Pseudomonas Aeruginosa
This is a non-randomized, single-blind post market clinical follow-up study for which 65 patients will be imaged at Rouge Valley Centenary Hospital (Scarborough and Rouge Hospital) who present with a chronic wound and are…
- Conditions
- Wound, Chronic Leg Ulcer, Wound Contamination
- Trial name
- NCT03290690
- Where
- Canada
- Volunteers
- 65 people
- Sponsor
- MolecuLight Inc.
Critical Limb Ischemia
Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for…
- Trial name
- NCT02099500
- Testing
- Liposuction, Stem Cell Injection
- Where
- United States
- Sponsor
- Ageless Regenerative Institute
Chronic Venous Leg Ulcers
TruSkin®: Study for Treatment of Chronic Venous Leg Ulcers
The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active Comparator in patients with chronic venous leg ulcers.
- Trial name
- NCT02936128
- Testing
- TruSkin, Wound Cover
- Where
- 7 sites in United States
- Volunteers
- 7 people
- Sponsor
- Osiris Therapeutics
Venous Leg Ulcer, Chronic Venous Insufficiency
Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)
The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device.
- Conditions
- Venous Leg Ulcer, Chronic Venous Insufficiency, Venous Stasis Ulcer, Venous Ulcer
- Trial name
- NCT02395302
- Testing
- Dual Action Pneumatic Compression
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Tactile Medical
Pressure Ulcers, Venous Ulcers
Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing
The clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds.
- Conditions
- Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Chronic Ulcer of Foot
- Trial name
- NCT01348581
- Testing
- Marigen Wound Dressing
- Where
- Iceland
- Volunteers
- 37 people
- Sponsor
- Kerecis Ltd.
Critical Limb Ischemia
Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI)
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores…
- Trial name
- NCT01245335
- Testing
- BMAC injection
- Where
- 34 sites in United States
- Volunteers
- 97 people
- Sponsor
- Harvest Technologies
Chronic Venous Leg Ulcers
Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers
The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to Standard of Care in the treatment of Chronic Venous Leg Ulcers.
- Trial name
- NCT02130310
- Testing
- CureXcell®
- Where
- 28 sites in United States
- Volunteers
- 252 people
- Sponsor
- Macrocure Ltd.
Critical Limb Ischemia, Peripheral Vascular Disease
Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to…
- Conditions
- Critical Limb Ischemia, Peripheral Vascular Disease, Foot Ulcers, Rest Leg Pain
- Trial name
- NCT00060996
- Testing
- Remodulin® (treprostinil sodium) Injection
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- United Therapeutics
Chronic Leg Ulcers, Wound Healing
Clinical Trial to Investigate Treatment With Photodynamic Therapy to Reduce Levels of Bacteria in Leg Ulcers
Some leg ulcers do not seem to respond that well to the standard treatments that we currently use. One reason for this may be that there are high levels of bacteria in the ulcer which may be slowing down the rate of healing.
- Trial name
- NCT00825760
- Testing
- Topical PPA904 gel and light
- Where
- 4 sites in United Kingdom
- Volunteers
- 57 people
- Sponsor
- Photopharmica
Chronic Venous Leg Ulcers
Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers
The purpose of this study is to evaluate if the investigational medicinal product CHRONSEAL intended for future treatment of chronic venous leg ulcers is safe and tolerated and if it has an ulcer size reduction effect when…
- Trial name
- NCT00797706
- Testing
- CHRONSEAL
- Where
- 16 sites in Norway, Sweden
- Volunteers
- 75 people
- Sponsor
- Kringle Pharma Europe AB
Diabetic Foot, Critical Limb Ischemia
A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia
The purpose of this study is to determine whether the method (implanting stem cells derived from peripheral blood after G-CSF mobilization) of treatment is safe and effective in the management of diabetic foot ischemia, the…
- Conditions
- Diabetic Foot, Critical Limb Ischemia, Leg Ulcers
- Trial name
- NCT00922389
- Testing
- will receive G-CSF and peripheral blood derived mononuclear cells, G-CSF, Standard Therapy
- Where
- India
- Volunteers
- 36 people
- Sponsor
- Beike Biotech India Pvt.ltd
Chronic Venous Leg Ulcers
Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy
Indication: Subjects with chronic venous leg ulcers Primary Objective: To evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic venous leg ulcers Secondary Objective(s): To evaluate the percentage…
- Trial name
- NCT00678847
- Testing
- KFH NOVO (inactive) + SCT, KFH Novo (BEST) + SCT
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- Kingfisher Healthcare