Clinical trials: Chronic Ulcer of Lower Extremity
Chronic Limb Threatening Ischemia
Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI)
Chronic limb-threatening ischemia (CLTI) is a serious condition that happens when blood flow to the legs or feet is severely reduced.
- Trial name
- NCT07175129
- Testing
- Transverse Tibial Bone Transport, TrueLok Elevate
- Where
- United States
- Sponsor
- University Hospitals Cleveland Medical Center
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
Wounds and Injuries, Burns
Clinical Registry Collecting Real World Evidence on Wound Care Treatments
The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.
- Conditions
- Wounds and Injuries, Burns, Mohs Surgery, Diabetic Foot Ulcer Mixed
- Trial name
- SIDDX (NCT06328010)
- Testing
- Various types of wound care treatments
- Where
- 12 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Siddhey LLC
Diabetes Mellitus, Diabetic Peripheral Neuropathy
Immunonutrition for Diabetic Foot Ulcers
Diabetes-induced peripheral neuropathy can lead to the development of diabetic foot ulcers (DFUs), which can have a devastating effect on patients' lives and can lead to life threatening infection, amputations, and even death.
- Conditions
- Diabetes Mellitus, Diabetic Peripheral Neuropathy, Diabetic Foot Ulcer
- Trial name
- NCT05281562
- Testing
- Lovaza, L-Arginine Powder, Vitamin C
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Prisma Health-Midlands
Diabetic Foot Ulcers, Venous Ulcers
Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds
This study will examine differences in the process of wound-healing in patients treated with platelet rich plasma (a concentration of proteins derived from a patients own blood) applied to the wound as a gel; injected into the…
- Conditions
- Diabetic Foot Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- CMS (NCT02071979)
- Testing
- Autologous PRP Gel, Autologous PRP Injections, Autologous PRP Gel plus PRP Injections
- Where
- 6 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Arteriocyte, Inc.
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
Vascular Diseases, Peripheral Artery Disease
RECCORD (Recording Courses of Vascular Diseases) Registry
The RECording COurses of vasculaR Diseases registry (RECCORD registry) is an observational, prospective, multicentre, all-comers registry platform.
- Conditions
- Vascular Diseases, Peripheral Artery Disease, Claudication, Critical Limb Ischemia
- Trial name
- RECCORD (NCT03448029)
- Where
- Germany
- Volunteers
- 6,000 people
- Sponsor
- Deutsche Gesellschaft für Angiologie, Gesellschaft für Gefäßmedizin e.V.
Platelet-Derived Growth Factor, Diabetic Foot
Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers
The purpose of this study is to retrospectively evaluate the safety of sterile becaplermin gel compared with sterile placebo gel treatment 12 months or more after the last dose was administered in 1 of 2 double-blind trials…
- Conditions
- Platelet-Derived Growth Factor, Diabetic Foot, Neoplasms
- Trial name
- NCT00740922
- Volunteers
- 563 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Foot Ulcer, Diabetic
Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers
This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.
- Trial name
- NCT02563522
- Testing
- Engensis (VM202)
- Where
- 22 sites in United States
- Volunteers
- 44 people
- Sponsor
- Helixmith Co., Ltd.
Diabetic Foot Ulcer
Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use
To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects.
- Trial name
- STRIDE 5 (NCT01840085)
- Testing
- 0.03% DSC127 topical gel
- Where
- 21 sites in United States
- Volunteers
- 261 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcer
Evaluation of a Folic Acid Wound Treatment (FAWT) for Chronic, Early-Stage Diabetic Foot Ulcer (DFU) Healing
This is a twelve-week single-center, randomized, double-blind, clinical study to evaluate the safety and efficacy of a folic acid wound treatment (FAWT) versus Placebo in the promotion of healing of chronic, early stage diabetic…
- Trial name
- NCT04723134
- Testing
- Folinic acid calcium salt
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Joseph Boykin, MD
Leg Ulcer, Varicose Ulcer
Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers
This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.
- Trial name
- NCT00399308
- Testing
- Celaderm (Frozen Cultured Epidermal Allograft), Control (compression bandaging)
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Shire
Venous Ulcer
Effectiveness of XCell on Autolytic Debridement of Venous Ulcers
This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for its ability to naturally (autolytically) remove nonviable tissue and create a healthy vascular wound bed.
- Trial name
- XCell (NCT00446823)
- Testing
- XCell cellulose wound dressing, Impregnated gauze dressing
- Where
- 3 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Xylos Corporation
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
Venous Leg Ulcer, Diabetic Foot Ulcer
EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management
Multi-center, prospective, interventional, uncontrolled open-label study evaluating the real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg ulcers, diabetic foot ulcers, pressure ulcers).
- Conditions
- Venous Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT03021811
- Testing
- KLOX LumiHeal BioPhotonic System
- Volunteers
- 100 people
- Sponsor
- KLOX Technologies Inc.
Partial Thickness Wound, Pressure Ulcer
The RESPOND Registry
The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings; no experimental intervention is involved.
- Conditions
- Partial Thickness Wound, Pressure Ulcer, Venous Ulcer, Diabetic Ulcer
- Trial name
- RESPOND (NCT03286452)
- Testing
- PuraPly™ Antimicrobial Wound Matrix
- Where
- 15 sites in United States
- Volunteers
- 310 people
- Sponsor
- Organogenesis
Non-Diabetic Patients, Wound Leg
Role of Tissue Oxygenation and the miR-210 Gene In Wound Healing
Hypothesis: Elevated miR210 in the epidermis (outer layer of skin) of ischemic human wound edge tissue (tissue that has a lack of blood flow to it) is associated with poor healing outcome in a setting of standard clinical care.
- Conditions
- Non-Diabetic Patients, Wound Leg, Chronic Ulcer Leg/Foot
- Trial name
- miR210 (NCT02024243)
- Where
- 3 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Chandan Sen
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 Ulcers
Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers
The primary goal of the study is to demonstrate the increased rate of complete wound closure by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers
- Trial name
- NCT02209051
- Testing
- AMNIOEXCEL, Standard of Care, Diabetic Foot Ulcers
- Where
- 8 sites in United States
- Volunteers
- 29 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot, Diabetic Neuropathies
Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy
This is an initial dose escalation safety and exploratory efficacy study to treat two groups of subjects with critically sized diabetic wounds and diabetic neuropathy using placental-derived stem cells (PDSC) transplanted by…
- Conditions
- Diabetic Foot, Diabetic Neuropathies, Diabetic Foot Ulcer
- Trial name
- PDSC (NCT06373809)
- Testing
- Transplantation of Placenta Derived Stem Cells
- Where
- 2 sites in Nicaragua
- Volunteers
- 20 people
- Sponsor
- Michael H Carstens