Clinical trials: Leg Ulcer
Diabetic Foot
Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers
The purpose of this study is to determine the ability of Apligraf to improve the time to and incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot ulcers treated with standard therapy.
- Trial name
- NCT00512538
- Testing
- Bi-layered cell therapy (Apligraf)
- Volunteers
- 82 people
- Sponsor
- Organogenesis
Diabetic Foot, Quality of Life
Patient Empowerment Study
The Patient Empowerment Study is an observational longitudinal study among adults with diabetic foot ulcer (DFU). The scope of this study is to better understand how a patient's DFU disease process and usage of the Podimetrics…
- Conditions
- Diabetic Foot, Quality of Life, Mental Health Wellness 1, Ulcer Foot
- Trial name
- NCT04537676
- Testing
- No intervention, this is an observational study
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Podimetrics, Inc.
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
Bacterial Infections, Diabetic Foot
Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.
The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.
- Conditions
- Bacterial Infections, Diabetic Foot, Osteomyelitis
- Trial name
- NCT00366249
- Testing
- Tigecycline, Ertapenem
- Where
- 211 sites in United States, Argentina and 37 more
- Volunteers
- 1,061 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer
MAtrix Therapy for Hard-to-heal ChrOnic Wounds
CACIPLIQ20® is currently a class III CE marked medical device available in various European and non-European countries, and currently primarily used in managing hard-to-heal wounds.
- Conditions
- Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer, Arterial Ulcer, Venous Ulcer of Leg
- Trial name
- MATHCOW (NCT05170984)
- Testing
- CACIPLIQ20®
- Where
- France
- Volunteers
- 191 people
- Sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
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.
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
Venous Leg Ulcers
A Study Of Pain And Quality Of Life Outcomes In Subjects With a Single Painful Venous Leg Ulcer Treated With Apligraf®
The objective of the study is to demonstrate that treatment with Apligraf reduces venous leg ulcer (VLU)-related pain and improves the quality of life (QOL) of patients with a painful VLU.
- Trial name
- NCT02011724
- Testing
- Apligraf
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Organogenesis
Venous Leg Ulcers (VLUs)
Assessing Connected-Health, Pressure-Monitoring Technology for Improving Compression Therapy in Venous Leg Ulcer Treatment
This study evaluates the effectiveness of a connected-health, pressure monitoring technology (Tight Alright) to improve clinical outcomes of compression therapy in patients with venous leg ulcers (VLUs).
- Trial name
- ACHIEVE (NCT07152717)
- Testing
- A connected-health, pressure-sensing system for monitoring sub-bandage pressure during compression therapy
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Feeltect Limited
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 Ulcers (DFUs), Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared to SOC alone in treating Wagner Grade 1 diabetic foot ulcers (DFUs) and…
- Trial name
- STRIDDDE (NCT06939686)
- Testing
- Miro3D Wound Matrix, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Reprise Biomedical, Inc.
Wound Heal, Venous Leg Ulcer
INNOVEN: Efficacy of Porcine Placental Extracellular Matrix Plus Standard of Care (SOC) Versus SOC Alone
INNOVEN is a multi-center randomized controlled clinical trial to evaluate the efficacy of porcine placental extracellular matrix (PPECM) and standard of care (SOC) versus SOC alone in the closure of non-healing venous leg ulcers…
- Trial name
- NCT06606210
- Testing
- InnovaMatrix® AC
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- ConvaTec Inc.
Venous Leg Ulcer (VLU), Venous Leg Ulcers
Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers
The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of hard-to-heal venous leg ulcers (VLU) between Intact Fish Skin Graft plus standard of care (IFSG/SOC)…
- Conditions
- Venous Leg Ulcer (VLU), Venous Leg Ulcers, Venous Leg, Nonhealing Venous Leg Ulcer
- Trial name
- THOR (NCT06693570)
- Testing
- Intact Fish Skin Graft (IFSG) + Standard of Care, Standard of Care
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Kerecis Ltd.
Diabetic Foot Ulcer
Clinical Study of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers
This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo therapy.
- Trial name
- NCT03754465
- Testing
- ALLO-ASC-DFU, Hydrogel SHEET(Vehicle control)
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Anterogen Co., Ltd.
Venous Leg Ulcer (VLU)
Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers
The purpose of this study is to evaluate the efficacy, safety and economic benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of venous leg ulcers.
- Trial name
- VaLUe I (NCT06754735)
- Testing
- Topical Wound Oxygen Therapy
- Where
- United States
- Volunteers
- 212 people
- Sponsor
- AOTI Ltd.
Critical Limb Ischemia, Peripheral Vascular Disease
Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures
The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to…
- Conditions
- Critical Limb Ischemia, Peripheral Vascular Disease, Foot Ulcers, Rest Leg Pain
- Trial name
- NCT00060996
- Testing
- Remodulin® (treprostinil sodium) Injection
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- United Therapeutics
Diabetes Mellitus, Foot Ulcer
REOXCARE Dressing to Improve Healing in Diabetic Foot Ulcers (DFU)
It has been shown that diabetic patients present a significant increase in markers related to oxidative stress, which increases even more in those with diabetic foot ulcers and gradually depending on the severity of the injury…
- Conditions
- Diabetes Mellitus, Foot Ulcer, Neuroischemic Foot Ulcer
- Trial name
- REOXDFU (NCT05413746)
- Testing
- Reoxcare antioxidant dressing
- Where
- 2 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Histocell, S.L.
Diabetic Foot Ulcers
Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
A Multicenter, Prospective, Randomized Controlled Comparative Parallel Study To determine the safety and effectiveness of EpiCord as compared to standard of care (SOC) therapy for the treatment of chronic, non-healing diabetic…
- Trial name
- NCT02844660
- Testing
- EpiCord, Standard of Care
- Where
- 13 sites in United States
- Volunteers
- 130 people
- Sponsor
- MiMedx Group, Inc.
Lower Extremity, Chronic Ulcers
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic lower extremity wounds.
- Conditions
- Lower Extremity, Chronic Ulcers, Pressure Ulcer (PU), Venous Leg Ulcer (VLU)
- Trial name
- NCT07862335
- Testing
- PRFM
- Volunteers
- 30 people
- Sponsor
- Tiger Biosciences, LLC.
Diabetic Foot Ulcer
BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers
This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer.
- Trial name
- NCT06383013
- Testing
- BB-101
- Where
- 5 sites in Taiwan
- Volunteers
- 96 people
- Sponsor
- Blue Blood Biotech Corp.