Clinical trials: Chronic Ulcer of Lower Extremity
Chronic Lower Leg Ulcer, Diabetic Lower Extremity Ulcers
Use of Hydroprep Wound Therapy With Motion Negative Pressure Therapy for Treatment of Chronic Lower Extremity Wounds
Use of a motorized waterjet to debride wounds to improve healing outcomes.
- Conditions
- Chronic Lower Leg Ulcer, Diabetic Lower Extremity Ulcers, Pressure Injuries, Traumatic Wounds and Injuries
- Trial name
- NCT07653165
- Testing
- Motion NPWT
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- West Boca Center for Wound Healing
Venous Ulcer
Preliminary Testing of New Treatment for Chronic Leg Wounds
The primary objectives of this study are to evaluate the efficacy, dosing, and safety of an intra-ulcer injection H5.020CMV.PDGF-b in adults who have a venous leg ulcer.
- Trial name
- NCT01858272
- Testing
- H5.020CMV.PDGF-b and limb compression bandage
- Volunteers
- 15 people
- Sponsor
- University of Pennsylvania
Diabetic Foot Ulcer
A Dose Finding Study of Topically Applied I-020201 as an Adjunct to Good Standard-of-care in Patients With Chronic Diabetic Foot Ulcers
Although major improvements in the management and treatment of diabetic foot ulcers have been made, the clinical and financial burden of such long-term wounds is still high and is likely to increase as the general population…
- Trial name
- DFU (NCT00915486)
- Testing
- Good Standard of Care (GSoC), Vehicle, I-020201
- Where
- 34 sites in Czechia, Germany and 4 more
- Volunteers
- 211 people
- Sponsor
- Kuros Biosurgery AG
Diabetic Foot Ulcer
Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers
The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU).
- Trial name
- NCT01113515
- Testing
- Esmolol hydrochloride
- Where
- 5 sites in United States, India and 1 more
- Volunteers
- 44 people
- Sponsor
- Novalead Pharma Private Limited
Diabetic Foot Ulcer
A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer
The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as compared to Standard of Care alone for the…
- Trial name
- NCT02236793
- Testing
- BioChaperone PDGF-BB, Standard of Care
- Where
- 32 sites in India
- Volunteers
- 252 people
- Sponsor
- Adocia
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
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
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
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
Wounds, Other Ulcers Wounds and Skin Problems
Safety and Efficacy of Topical AR/101 Compared With Placebo, in Accelerating Granulation Tissue Formation of Hard-to-heal Wounds
This prospective, placebo-controlled, double blind, randomized study is designed to assess the healing effects of AR/101 on chronic Hard-to-Heal wound(s) of different etiologies including arterial ulcers, diabetic ulcers and…
- Trial name
- NCT02839226
- Testing
- AR/101
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- Arava Bio Tech Ltd.
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
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 Venous Hypertension With Ulcer
Standard Compression Therapy With/Without Application of Skin Allograft (Theraskin) for Venous Leg Ulcer Treatment
This study will compare the efficacy of using standard compression therapy for treatment of chronic venous leg ulcers vs. the standard compression therapy with the additional use of the application of a human allograft (Theraskin)
- Trial name
- NCT03935386
- Testing
- Standard Multi-layered Compression dressing, Standard Multi-layered Compression dressing with a cryopreserved skin allograft (TheraSkin)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Solsys Medical LLC
Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs)
HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU
This retrospective multi-site observational cohort study uses electronic health records (EHR) from U.S. wound care centers to evaluate the effectiveness of four amniotic membrane allografts (Acesso DL, Acesso TL, Neostim DL…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trial name
- HEAL-4 (NCT07223515)
- Where
- 2 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Dynamic Medical Services dba Acesso Biologics
Diabetic Foot Ulcer, Type 1 Diabetes Mellitus
Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.
The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2…
- Conditions
- Diabetic Foot Ulcer, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM), Neuroischemic Foot Ulcer
- Trial name
- NCT06810726
- Testing
- Platelet Rich Plasma
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Estar Medical dba Medical Technologies, LTD
Diabetic Foot, Ulcer Foot
SDRM® vs. Collagen for Diabetic Foot Ulcers
Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing.
- Conditions
- Diabetic Foot, Ulcer Foot, Wound Heal
- Trial name
- NCT05883098
- Testing
- Wound debridement, Wound closure matrix application
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Polymedics Innovations Inc.
Skin Ulcer
Bio-ConneKt Wound Dressing for Treatment of Chronic Leg Wounds: A Pilot Study
The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers…
- Trial name
- NCT02309684
- Volunteers
- 20 people
- Sponsor
- MLM Biologics Inc.,
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
Lower Limb Ischemia Critical
Outcomes of Endovascular Revascularization in CLTI in Patients Associated With Heel Ulcers
The aim of the current study is to assess outcomes of endovascular revascularization of patients with CLTI associated with heel ulcers and identify possible predictors of healing of these ulcers.
- Trial name
- NCT05570968
- Testing
- C-arm device
- Volunteers
- 100 people
- Sponsor
- Assiut University
Diabetic Foot Ulcer
Shockwave Therapy of Chronic Diabetic Foot Ulcers
Introduction: Foot ulcers are a feared complication among diabetic patients. The ulcers can cause pain, discomfort and reduced quality of life. The development of foot ulcers places the patients at a risk of amputation.
- Trial name
- NCT02251418
- Testing
- Extracorporeal shockwave therapy
- Where
- Denmark
- Volunteers
- 23 people
- Sponsor
- Odense University Hospital