Clinical trials: Chronic Ulcer of Lower Extremity
Venous Leg Ulcers
A Prospective, Randomized Clinical Trial of PRP Concepts Fibrin Bio-Matrix in Chronic Non-Healing Venous Leg 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 venous leg ulcers (VLU).
- Trial name
- NCT02312518
- Testing
- PRP Concepts Fibrin Bio-Matrix, Usual and Customary Practice
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- PRP Concepts, LLC
Chronic Lower Leg Ulcer
Autologous Platelet Enriched Gel Versus Metalloproteinase Inhibitor in the Healing of Chronic Lower Leg Ulcers
Compare Autologous Platelet Enriched Gel versus Metalloproteinase Inhibitor in the healing of chronic lower leg ulcers.
- Trial name
- NCT00658983
- Testing
- Autologous Platelet Enriched Gel, Metalloproteinase Inhibitor
- Where
- Belgium
- Volunteers
- 18 people
- Sponsor
- University Hospital, Ghent
Diabetic Foot
Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs
The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 2 diabetic foot ulcers.
- Trial name
- COVER DFUs (NCT05372809)
- Testing
- SkinTE, Control
- Where
- 13 sites in United States
- Volunteers
- 42 people
- Sponsor
- PolarityTE
Venous Leg Ulcer (VLU)
EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF VENOUS OR MIXED LEG ULCERS PRESENTING INFLAMMATORY SIGNS SUGGESTING HEAVY BACTERIAL LOAD
Evaluation of the efficacy (reduction of inflammatory signs suggesting a local infection) and tolerance (emergence and nature of adverse event) of Vashe solution vs Saline solution in the treatment of venous or mixed leg ulcers…
- Trial name
- NCT07440797
- Testing
- Saline solution, Vashe solution
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Laboratoires URGO
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
Neuropathic Diabetic Ulcer - Foot
Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
The purpose of this study is to assess the safety of the RedDress Wound Care System (RD1) in patients Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
- Trial name
- NCT01396837
- Testing
- RedDress Wound Care System (RD1)
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- RedDress Ltd.
Diabetic Foot Ulcer
Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells
The aim of this study is to investigate efficiency of applying of adipose-derived mesenchymal stem cells (ADSC) in treatment of chronic wounds in diabetic foot syndrome.
- Trial name
- 1ABC (NCT03865394)
- Testing
- Application of allogeneic ADSC stem cells in fibrin gel, Standard care in diabetic foot ulcer
- Where
- Poland
- Volunteers
- 46 people
- Sponsor
- Medical University of Warsaw
Diabetes
Investigating Ultrasound Debridement in Wound Care
The initial step of wound management, debridement, is thought to be critical in promoting wound healing. Of the numerous debridement modalities, ultrasound seems to hold promising results in accelerate healing in our own clinical…
- Trial name
- NCT03516422
- Testing
- ULTRASOUND DEBRIDEMENT, STANDARD CARE GROUP
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
Pressure Ulcer, Venous Ulcer
PuraPly™ Antimicrobial Wound Matrix and Wound Management
The PuraPly Antimicrobial Wound Matrix (PuraPly AM) case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylenbiguanide…
- Conditions
- Pressure Ulcer, Venous Ulcer, Diabetic Ulcer, Surgical Wound
- Trial name
- PuraPlyAM (NCT03070938)
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcer
Evaluation of Safety of Low Level Laser Device Treatment in Chronic Wounds
This is a randomized, double blind, placebo-controlled study to evaluate the safety of the low level laser MC-8XL device treatment in subjects with an unsuccessfully treated Diabetic Foot Ulcer (DFU) that has been present for at…
- Trial name
- NCT03204149
- Testing
- MC-8XL low level laser device and Standard wound care
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- Medical Coherence LLC
Critical Limb Ischemia
Registry of First-line Treatments in Patients With Critical Limb Ischemia
The principal research question is which treatment modality between open surgical, endovascular and conservative therapy is the most effective in terms of limb salvage, survival and reinterventions in patients with critical limb…
- Trial name
- CRITISCH (NCT01877252)
- Testing
- Surgical revascularization, Endovascular revascularization, No vascular intervention
- Where
- Germany
- Volunteers
- 1,200 people
- Sponsor
- St. Franziskus Hospital
Diabetes
Effect of Platelet Concentrate in Treatment of Diabetic Ulcers
Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds
- Trial name
- NCT00215735
- Testing
- debridement, dressing, and APC
- Where
- 9 sites in United States
- Sponsor
- Harvest Technologies
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
Critical Limb Ischemia
Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
- Trial name
- NCT02046226
- Testing
- Oxygenesys(TM) Dissolved Oxygen Dressing
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Halyard Health
Leg Ulcers, Diabetic Foot Ulcer
Vacuum Compression Therapy for Chronic Lower Limb Ulcers
The goal of this clinical trial is to learn if vacuum compression therapy added to standard care improves wound healing in adults with chronic lower limb ulcers.
- Conditions
- Leg Ulcers, Diabetic Foot Ulcer, Varicose Ulcers, Skin Ulcer
- Trial name
- NCT07737184
- Testing
- Vacuum Compression Therapy (VCT), Standardized Wound Care
- Where
- Czechia
- Volunteers
- 50 people
- Sponsor
- BTL Industries Ltd.
Diabetes Mellitus, Diabetic Foot Ulcer
Evaluation of 3D Imaging Ulcer Camera
The aim of the study is to evaluate the intra- and inter-rater variability of wound measurements using the 3D camera and to compare with standard measurement methods (2D image method and gel injection).
- Conditions
- Diabetes Mellitus, Diabetic Foot Ulcer, Wound, Chronic Disease
- Trial name
- 3D-DFU (NCT03063138)
- Where
- Denmark
- Volunteers
- 48 people
- Sponsor
- Odense University Hospital
Wound
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact…
- Trial name
- NCT03877484
- Testing
- ALLEVYN Gentle border
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Venous Leg Ulcer, Lymphovenous Edema
Lymphovenous Bypass Manage Venous Leg Ulcers
Leg ulcers are areas of epidermal discontinuity in lower limbs with causes of venous, arterial, diabetic, pressure, traumatic, allergic, or inflammation.
- Trial name
- NCT05068258
- Testing
- Lymphovenous bypass, including lymphaticovenular anastomosis/implantation
- Where
- Taiwan
- Volunteers
- 31 people
- Sponsor
- National Taiwan University Hospital
Diabetic Foot Ulcer
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area including intact skin healing.
- Trial name
- FEENICS (NCT00662831)
- Testing
- Fragmin/ Dalteparin Sodium
- Where
- 63 sites in Austria, Belgium and 15 more
- Volunteers
- 276 people
- Sponsor
- Pfizer
Chronic Venous Insufficiency
Tissue Engineered Veins in Patients With Chronic Venous Insufficiency
This study aims to evaluate the safety (incidence of adverse events including serious adverse events and clinical significant laboratory abnormalities) of personalized tissue engineered veins (P-TEV) with valves implanted in…
- Trial name
- TECVI-1 (NCT03784131)
- Testing
- P-TEV
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Verigraft AB