Clinical trials: Chronic Ulcer of Lower Extremity
Venous Leg Ulcer (VLU)
ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds.
- Trial name
- ConvaVAC VLU (NCT07342049)
- Testing
- ConvaVAC™ Ag+ Negative Pressure Wound Therapy System
- Where
- 7 sites in Chile, United Kingdom
- Volunteers
- 87 people
- Sponsor
- ConvaTec Inc.
Diabetic Foot, Chronic Foot Ulcer
Randomized Clinical Study Comparing SynPath to Standard of Care in Treatment of Chronic Diabetic Foot Ulcers
The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment.
- Conditions
- Diabetic Foot, Chronic Foot Ulcer, Wound Healing, Foot Ulcer
- Trial name
- DFUs (NCT05506215)
- Testing
- SynPath Acellular Dermal Matrix plus Off-loading Device, Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- PolyNovo Biomaterials Pty Ltd.
Diabetic Foot Ulcer
High Intensity LED Photobiomodulation Therapy for Chronic Leg and Foot Ulcers
Diabetic and venous ulcers affect many people, and severe cases can end up in amputation and even death because of infection. In 2011, the total cost for care of diabetic foot ulcers alone, to the Canadian health care system, was…
- Trial name
- NCT04300205
- Testing
- High intensity LED light device
- Where
- Canada
- Volunteers
- 33 people
- Sponsor
- Illumacell Inc.
Leg Ulcer, Pain
Pain in Chronic Leg- and Foot Ulcers
Leg ulcers are a significant cause of impaired functional ability and quality of life for approximately 1-2 percent of the population in western countries.
- Trial name
- NCT03086577
- Where
- Norway
- Volunteers
- 360 people
- Sponsor
- University College of Southeast Norway
Diabetes, Diabetic Foot Ulcer
Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management
The aim of the study is to assess the cost-effectiveness of telemedicine in the care of chronic diabetic foot ulcers. Patients will be randomized into 2 groups: 1/conventional care group with iterative visits to diabetes…
- Trial name
- AIRPEDIA (NCT01814267)
- Testing
- telemedicine, conventional
- Where
- France
- Volunteers
- 14 people
- Sponsor
- University Hospital, Grenoble
Diabetic Foot Ulcer
PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS
Study Objective: The objective of this Phase 1 open-label study is to establish the safety and tolerability of Corlicyte mesenchymal stem cells (MSCs) in the treatment of patients with chronic diabetic foot ulcers (DFUs).
- Trial name
- NCT04104451
- Testing
- Corlicyte
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of Colorado, Denver
Chronic Venous Leg Ulcers
Impact of Omega-3 Fatty Acid Oral Therapy on Healing of Chronic Venous Leg Ulcers in Older Adults
The purpose of this study is to test the efficacy of an oral, nutrient intervention containing the bioactive components of fish oil to promote healing of chronic venous leg ulcers (CVLUs) by reducing the chronic inflammation at…
- Trial name
- NCT03576989
- Testing
- EPA+DHA
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- Ohio State University
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
Lower Extremity Chronic Ulcers in Diabetics
Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. These ulcers are reported to be the leading cause of hospitalization among people with diabetes.
- Trial name
- NCT01421966
- Testing
- CureXcell®
- Where
- 37 sites in United States, Canada and 1 more
- Volunteers
- 285 people
- Sponsor
- Macrocure Ltd.
Venous Leg Ulcer, Bacterial Infections
Effectiveness of a Hydrophobic Dressing for Microorganisms' Colonization and Infection Control of Vascular Ulcers
This study will determine the effectiveness of CUTIMED® hydrophobic dressings against AQUACEL® silver dressings in bacterial colonization of vascular ulcers.
- Conditions
- Venous Leg Ulcer, Bacterial Infections, Chronic Ulcer of Skin of Lower Limb Nos
- Trial name
- CUCO-UV (NCT03667937)
- Testing
- CUTIMED, AQUACEL silver
- Where
- Spain
- Volunteers
- 204 people
- Sponsor
- University of Malaga
Varicose Ulcer
Preliminary Testing of New Treatment for Chronic Leg Wounds
Most chronic (long-lasting) wounds of the leg (also known as venous ulcers) fail to heal in a reasonable period of time. Although researchers have made great progress in understanding how the body repairs wounds, attempts to…
- Trial name
- NCT00000431
- Testing
- PDGF-B/Ad5
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Pennsylvania
Diabetic Foot Ulcer
Efficacy and Safety Study of Dermal-Living Skin Replacement to Treat Diabetic Foot Ulcers
The purpose of this study is to test the efficacy and side effects, if any, of Dermal - LSR combined with standard treatment. We hypothesize the treatment will provide beneficial results for diabetic patients suffering foot…
- Trial name
- NCT00368693
- Testing
- Dermal - Living Skin Replacement (Dermal-LSR)
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Varicose Ulcer
Vein Fitness System vs Compressive Therapy for Venous Ulcers: a Bayesian Adaptive Trial
The objective of this Bayesian Adaptive trial is to compare a control group versus a comprehensive ulcer healing protocol. The latter involves a combination of compressive therapy, miokinetic drainage and muscle strengthening for…
- Trial name
- NCT03127904
- Testing
- Vein Fitness, Compressive therapy and wound care
- Where
- Brazil
- Volunteers
- 120 people
- Sponsor
- Pró Circulação®
Chronic Wounds, Burns
THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers
Pilot observational clinical evaluation assessing the safety and potential effectiveness of THERAVEX Tissue Care Spray Plus as an adjunctive topical therapy for the management of cutaneous wounds, burns, traumatic lesions…
- Conditions
- Chronic Wounds, Burns, Pressure Ulcer, Traumatic Wounds
- Trial name
- NCT07617961
- Testing
- THERAVEX TISSUE CARE SPRAY PLUS
- Where
- Spain
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Biointelligent Technology Systems SL
Venous Leg Ulcer
Clinical Study Of Affinity Versus SOC In The Management Of VLUs
This prospective, multi-center, randomized, controlled clinical study compares Affinity® plus SOC to SOC alone in subjects with VLUs.
- Trial name
- NCT04901013
- Testing
- Affinity
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Organogenesis
Leg Ulcer
Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds
The main objective of this study is to estimate the change in the relative numbers of commensal or low virulence potential bacteria before and after one session TDP.
- Trial name
- PDT-Bactério (NCT02392390)
- Testing
- Topical Dynamic Phototherapy (TDP), Metvixia cream
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
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
Diabetic Foot, Chronic Osteomyelitis
Predictive Value of Nu.Q™ Biomarkers to Help Guiding the Management of Osteoarticular Infections
Diabetic foot ulcers are frequent with average lifetime risk of 15%, and can lead to bone and joint infections. Current protocols for their management include evaluation of ischemia, assessment of underlying bone infection, sharp…
- Conditions
- Diabetic Foot, Chronic Osteomyelitis, Septic Arthritis
- Trial name
- NCT05593874
- Testing
- Histones H3.1 blood levels
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- University Hospital, Geneva
Charcot Joint of Foot, Osteoarthropathy
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot foot, characterized by progressive destructive damage to bone, soft tissue and tendons, involving joint dislocation in the ankle and foot, is a complication of diabetes that is still poorly understood by patients and…
- Trial name
- CHARQUAM (NCT05491577)
- Testing
- Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire
- Where
- 17 sites in France
- Volunteers
- 150 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Chronic Ulcer, Venous Ulcer
Efficacy of PICO Single-use System in Chronic Ulcers
A clinical trial will be carried out comparing the efficacy of PICO system based on negative pressure therapy (NPT) in adults with chronic ulcers compared to conventional treatments.
- Conditions
- Chronic Ulcer, Venous Ulcer, Diabetic Foot Ulcer, Pressure Injury
- Trial name
- NCT05877378
- Testing
- Single-use negative pressure therapy (PICO)
- Where
- Spain
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University of Castilla-La Mancha