Clinical trials: Foot Injuries and Disorders
Diabetic Foot Ulcer, Surgical Wound
The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
- Trial name
- NCT03905863
- Testing
- Natrox® Oxygen Wound Therapy
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Inotec AMD Limited
Foot and Ankle Surgeries, Bunion
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries
Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often underestimated. However there has been growing emphasis on identification of these injuries and practice patterns.
- Trial name
- NCT03653429
- Testing
- Tranexamic Acid, Normal saline
- Where
- 2 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Diabetic Foot Ulcers, Wound
Topical Oxygen Therapy for Diabetic Wounds
This is a pilot study which is intended to collect data to calculate an adequate sample size for a larger registered clinical trial.
- Trial name
- NCT02313428
- Testing
- Topical Oxygen Chamber for Extremities
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Indiana University
Wound Heal, Peripheral Artery Disease
Safety and Efficacy of the Noxsano Wound Care Bandage
This study is a prospective, interventional, non-randomized study designed to assess the safety and efficacy of the Noxsano Bandage (study device) in healthy subjects and wound care subjects with a diabetic lower extremity…
- Conditions
- Wound Heal, Peripheral Artery Disease, Ulcer, Leg, Ulcer Foot
- Trial name
- NCT04123093
- Testing
- Noxsano Bandage (Healthy Volunteers), Noxsano Bandage (Wound Care)
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- OhioHealth
Pressure Ulcer, Ankle, Prosthesis User
Limb Health and Socket Pressure in Response to Powered Ankle Protheses
this project seeks to understand and quantify the effects of powered transtibial prostheses on socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit.
- Conditions
- Pressure Ulcer, Ankle, Prosthesis User, Prosthesis Durability, Mobility Limitation
- Trial name
- OPORP (NCT05112679)
- Testing
- PROPRIO FOOT® by Ossur & Empower ankle by Ottobock
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Indiana University
Diabetes, Type 1, Diabetes, Type 2
The Relationship of Hemoglobin A1c and Diabetic Wound Healing
The purpose of this study is to investigate the relationship of hemoglobin A1c in diabetic wound healing. Additionally, a comparison of two wound dressings, AmeriGel® (Amerx Health Care Corp., Clearwater, FL) and Bacitracin, with…
- Conditions
- Diabetes, Type 1, Diabetes, Type 2, Foot Ulcer, Diabetic
- Trial name
- NCT01350102
- Testing
- Bacitracin, AmeriGel®, Vitamin C
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Susan Hassenbein
Symptomatic Neuroma, Morton's Neuroma
Study of AxoGuard® Nerve Cap and Neurectomy for Treatment of Symptomatic Neuroma & Prevention of Recurrent Neuroma Pain
Comparing safety, pain, user experience, healthcare economic costs, work productivity, impairment and quality of life outcomes between Axoguard® Nerve Cap and neurectomy in the treatment of symptomatic neuromas in the foot or…
- Conditions
- Symptomatic Neuroma, Morton's Neuroma, Chronic Nerve Pain
- Trial name
- REPOSE (NCT03940963)
- Testing
- AxoGuard® Nerve Cap, Standard Neurectomy
- Where
- 11 sites in United States
- Volunteers
- 86 people
- Sponsor
- Axogen Corporation
Diabetic Foot Ulcers
Negative Pressure Wound Therapy as a Drug Delivery System
The investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound therapy with continuous…
- Trial name
- NCT02463487
- Testing
- Cardinal Pro +Simultaneous Irrigation (NPWTi), Cardinal Pro (NPWT) Therapy
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Texas Southwestern Medical Center
Foot Fusion
Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions) STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone…
- Trial name
- NCT00583375
- Testing
- Augment® Bone Graft, Standard of Care
- Where
- 37 sites in United States, Canada
- Volunteers
- 414 people
- Sponsor
- BioMimetic Therapeutics
Wounds
Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds
This is a non-randomized evaluation for which 50 patients will be imaged at the Southwest Regional Wound Care Center, Lubbock, Texas, who present with a chronic wound and are receiving standard treatment.
- Trial name
- NCT02682069
- Testing
- MolecuLight i:X Imaging Device
- Volunteers
- 30 people
- Sponsor
- MolecuLight Inc.
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB
Diabetic Foot Ulcer, Pressure Ulcer
A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1
The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss…
- Conditions
- Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer, Trauma Injury
- Trial name
- NCT04577183
- Testing
- RD1 System
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- RedDress Ltd.
Diabetic Foot Ulcer of Neuropathic Origin
The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Northern Europe The TRANS-North Study
Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan).
- Trial name
- TRANS-North (NCT01217476)
- Testing
- Trafermin 0.01% spray
- Where
- 37 sites in Belgium, Bulgaria and 8 more
- Volunteers
- 207 people
- Sponsor
- Olympus Biotech Corporation
Diabetic Foot Ulcer, Ulcer Foot
Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds.
- Conditions
- Diabetic Foot Ulcer, Ulcer Foot, Diabetic Foot
- Trial name
- NCT06403605
- Testing
- Mirragen Advanced Wound Matrix, Fibracol
- Where
- 15 sites in United States
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- ETS Wound Care, LLC
Foot Injuries and Disorders
SCANREP: Reliability of 3D Lower Limb Scanning
3D limb scanning systems have recently been implemented for the clinical fitting of prosthetic and orthotic devices due to substantial decreases in costs.
- Trial name
- NCT04032041
- Testing
- Structure Sensor, Caliper
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Iowa
Diabetic Foot, Wound
Extracorporeal Shockwave Therapy for Diabetic Foot Wounds
Diabetic wounds post digital amputation have poor healing in 30-45% of cases, resulting in 75% of patients undergoing a further amputation within the year, despite best wound management.
- Trial name
- NCT04042285
- Testing
- Extracorporeal shockwave therapy in addition to standard care
- Where
- United Kingdom
- Volunteers
- 24 people
- Sponsor
- Hull University Teaching Hospitals NHS Trust
Diabetes, Foot Ulcers
Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
Primary objective To assess wound healing and granulation tissue formation when using the NPWT system Secondary objectives To investigate the pain level at dressing removal To visually check exudate removal To investigate the…
- Trial name
- NCT01011387
- Testing
- NPWT System
- Where
- 2 sites in United Kingdom
- Volunteers
- 16 people
- Sponsor
- Molnlycke Health Care AB
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer, Non-healing Wound
Debritom - Micro Water Jet Technology and Wound Healing
This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.
- Conditions
- Diabetic Foot Ulcer, Non-healing Wound, Non-Healing Ulcer of Skin, Venous Leg Ulcer
- Trial name
- NCT04240574
- Testing
- Debritom
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Stephanie Wu
Ankle Fractures, Post-traumatic Osteoarthritis
Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. Research suggests that ankle arthritis develops after ankle fracture, in part, due to elevated forces on the cartilage.
- Conditions
- Ankle Fractures, Post-traumatic Osteoarthritis, Osteoarthritis Ankle
- Trial name
- PRMRP-FPA2 (NCT04562896)
- Testing
- Custom Carbon Fiber Dynamic Orthosis (CDO)
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Iowa