Clinical trials: Chronic Foot Ulcer
Diabetic Foot Ulcer
A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
This prospective, multi-center, randomized, controlled modified platform Trial compares Purified Native Type 1 Collagen Extracellular Matrix with Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care versus…
- Trial name
- PREPARE (NCT06618612)
- Testing
- Standard of Care, PuraPly AM, PuraPly XT
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcer
DermACELL in Subjects With Chronic Wounds of the Lower Extremities
The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
- Trial name
- NCT01970163
- Testing
- DermACELL, GraftJacket, Conventional Care Dressings
- Where
- 12 sites in United States
- Volunteers
- 202 people
- Sponsor
- LifeNet Health
Lower Extremity or Diabetic Foot Ulcers, Bacterial Infection
Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm
This is a prospective study of Veterans with chronic lower extremity or diabetic foot ulcers who will be randomized to either a Larval Debridement Therapy group (Biobags every 4 days x 2 applications) or a Sharp Debridement…
- Trial name
- NCT02294175
- Testing
- Larval Debridement Therapy, Bedside Sharp Debridement
- Where
- 2 sites in United States
- Volunteers
- 45 people
- Sponsor
- North Florida Foundation for Research and Education
Diabetic Foot Ulcer
Study Assessing Safety and Efficacy of B-cure Laser Treating Diabetic Chronic Wounds
For centuries, light has been a well-known and effective healing method. In the beginning of the 20th century there was a first attempt to condense light energy and distribute it in higher levels, a use that was successfully…
- Trial name
- NCT01493895
- Testing
- standard hoem treatment, LLLT-808 B-cure laser machine
- Where
- Israel
- Sponsor
- Hadassah Medical Organization
Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer), Chronic Wound Care
Clinical Performance of ComBatic™ Antimicrobial Wound Care Products in Hard-to-Heal Wounds
The goal of this clinical trial is To assess the feasibility of delivering the study protocol in adults with chronic, hard-to-heal lower leg wounds.
- Trial name
- COMBAT-H (NCT07872930)
- Testing
- Irrigation Solution for wounds, Hydrogel for wound care
- Volunteers
- 96 people
- Sponsor
- University of Calgary
Peripheral Arterial Disease(PAD), Arterial Occlusive Disease
Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
The goal of this observational study is to learn about the long-term effects of Donaperminogene Seltoplasmid Injection (NL003) in participants who have been received drug NL003 or placebo at least one dose from the parent phase…
- Conditions
- Peripheral Arterial Disease(PAD), Arterial Occlusive Disease, Arteriosclerosis Obliterans, Thromboangiitis Obliterans
- Trial name
- NCT07023965
- Testing
- NL003
- Where
- 5 sites in China
- Volunteers
- 542 people
- Sponsor
- Beijing Northland Biotech. Co., Ltd.
Ulcus Cruris
Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds
This is a randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. The study will be conducted at a single center with a total of 70 patients.
- Trial name
- NCT01434914
- Testing
- octenisept®
- Where
- Germany
- Volunteers
- 9 people
- Sponsor
- Schülke & Mayr GmbH
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
Foot Ulcer, Diabetic
Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix
The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without…
- Trial name
- HEALED (NCT01729286)
- Testing
- PriMatrix Moist Wound Therapy, Standard of Care Moist Wound Therapy
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 92 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
PAW-Hydrogel for Chronic Wound Healing
The goal of this randomized controlled trial is to evaluate the efficacy and safety of a novel hydrogel made of Carbopol® 940 functionalized with Plasma-Activated Water (PAW) in patients with chronic wounds (diabetic foot ulcers…
- Conditions
- Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU), Wound Dehiscence, Venous Leg Ulcer
- Trial name
- NCT07541196
- Testing
- PAW-Functionalized Carbopol® 940 Hydrogel, Standard Advanced Wound Care
- Where
- Mexico
- Volunteers
- 50 people
- Sponsor
- Benjamín Gonzalo Rodríguez Méndez
Pressure Injury, Venous Leg Ulcer
Pivotal Study of an Antimicrobial Wound Dressing to Treat Chronic Wounds
The goal of this clinical trial is to assess the impact that the NanoSALV wound dressing can have on managing severe chronic wounds and feasibility for patients, providers, and health systems in different health care settings…
- Conditions
- Pressure Injury, Venous Leg Ulcer, Pressure Injury Stage 2, Pressure Injury Stage III
- Trial name
- NCT05619237
- Testing
- NanoSALV Catalytic
- Where
- 4 sites in Canada
- Volunteers
- 44 people
- Sponsor
- Chester Ho, MD
Diabetic Foot Ulcer
Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers.
- Trial name
- TWO2DFU (NCT02326337)
- Testing
- TWO2 Device
- Where
- 17 sites in United States, France and 3 more
- Volunteers
- 73 people
- Sponsor
- AOTI Ltd.
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
Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing
The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics…
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU), Pressure Ulcer (PU)
- Trial name
- RETRO-PLAST (NCT07375160)
- Testing
- dHPT, AIC
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Cellution Biologics
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
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
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
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