Clinical trials: Chronic Ulcers of the Lower Limb
Diabetic Foot Ulcers
TruSkin®: Study for the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active Comparator in patients with chronic diabetic foot ulcers.
- Trial name
- NCT02936115
- Testing
- TruSkin®, Wound Cover
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Osiris Therapeutics
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.
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
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
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
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
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
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
Diabetic Foot Ulcer
Pilot Study of PHOENIX Wound Matrix® Impact on Chronic DFU Wound Microbiome
A Pilot Study to Determine the Impact of the Phoenix Wound Matrix® on the Wound Microbiome in Chronic Diabetic Foot Ulcers
- Trial name
- NCT04437537
- Testing
- Bioresorbable 3D electrospun synthetic matrix
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- RenovoDerm
Sickle Cell Leg Ulcer
Test of the Safety, Effectiveness, & Acceptability of An Improvised Dressing for Sickle Cell Leg Ulcers in the Tropics
One in 300 Jamaicans have HbSS sickle cell disease, and of these, up to 70% will suffer from sickle cell leg ulcers (SCLUs). Of these, 24% will have a chronic SCLU (one lasting longer than 6 months).
- Trial name
- SCLUJamaica (NCT04479618)
- Testing
- Usual Practice, Improvised dressing, Advanced dressing
- Where
- Jamaica
- Volunteers
- 48 people
- Sponsor
- Benskin, Linda, PhD, RN, SRN (Ghana), CWCN, CWS, DAPWCA
Impaired Wound Healing, Venous Insufficiency of Leg
Clinical Trial to Evaluate Blister Graft Utilizing a Novel Harvesting Device for Treatment of Venous Leg Ulcers
Epidermal grafts are believed to promote healing by two mechanisms: graft take and the promotion of wound healing through the delivery of growth factors and the essential elements of tissue repair and wound healing.28 This study…
- Conditions
- Impaired Wound Healing, Venous Insufficiency of Leg, Diabetic Ulcers
- Trial name
- Cellutome (NCT02148302)
- Testing
- Harvesting Device (CelluTome©)
- Where
- 18 sites in United States
- Volunteers
- 123 people
- Sponsor
- SerenaGroup, Inc.
Chronic Ulcer of Lower Extremity
Topical Nitric Oxide Trial in Chronic Non-Healing Wounds
To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by measurements of wound size and wound culture.
- Trial name
- NCT00823095
- Testing
- Nitric Oxide
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Loma Linda University
Varicose Ulcer
Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb
Chronic venous ulceration of the lower limb poses a significant problem to patients and healthcare providers alike. 1% of the population of Western countries have either an open or healed chronic venous ulcer.
- Trial name
- MOJITO (NCT01998932)
- Where
- 2 sites in United Kingdom
- Volunteers
- 28 people
- Sponsor
- Imperial College London
Chronic Diabetic Foot Ulcers
Safety & Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Diabetic Foot Ulcers
The purpose of this clinical study is to compare the safety and effectiveness of shockwave treatment combined with standard-of-care treatment, to standard-of-care treatment alone to induce healing of a chronic plantar foot ulcer…
- Trial name
- NCT00366132
- Testing
- Extracorporeal Shockwaves
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Tissue Regeneration Technologies