Clinical trials: Foot Injuries and Disorders
Diabetic Foot Ulcers
A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers
The objective of this study is to compare the reduction in wound surface areas between patients with diabetic ulcers utilizing Provant's pulsed radio frequency energy therapy (PRFE) as an adjunct to standardized basic wound care…
- Trial name
- NCT00761176
- Testing
- The Provant Therapy System
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Regenesis Biomedical, Inc.
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, Peripheral Arterial Disease
A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.
This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).
- Conditions
- Diabetic Foot Ulcer, Peripheral Arterial Disease, Wound; Foot
- Trial name
- Dulcet (NCT05145439)
- Testing
- VibratoSleeve Therapeutic Ultrasound Device
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Vibrato Medical, Inc.
Diabetic Foot Ulcer
Study of Oasis Ultra in Diabetic Foot Ulcers
Many people with diabetes will develop a non-healing diabetic foot ulcer. Many ways are available to try to get a diabetic foot ulcer to heal, including application of Oasis Ultra.
- Trial name
- NCT01835379
- Testing
- Oasis, Standard
- Where
- 16 sites in United States
- Volunteers
- 82 people
- Sponsor
- Healthpoint
Diabetic Foot Ulcers
A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies
A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.
- Trial name
- NCT00605189
- Testing
- Powered Suction Pump (VAC Freedom), Powered Suction Pump, MWT
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- KCI USA, Inc
Diabetic Foot Ulcer
A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs
This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the…
- Trial name
- NCT02181621
- Testing
- Iodosorb, Solosite gel
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Smith & Nephew, Inc.
Surgical Wound, Diabetes
EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds
The investigators will test the efficacy of the novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System for use in caring for patients with surgically closed wounds.
- Conditions
- Surgical Wound, Diabetes, Amputation Wound, Incision Wound
- Trial name
- NCT03960463
- Testing
- Transcu O2®
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Baylor College of Medicine
Diabetic Foot Ulcer
MIRODERM H2H DFU Study
This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.
- Trial name
- H2H-DFU (NCT03232333)
- Testing
- Biologic wound graft
- Where
- 9 sites in United States
- Volunteers
- 53 people
- Sponsor
- Miromatrix Medical Inc.
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
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
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
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
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
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.
Diabetes, Diabetic Foot
Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care
This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard…
- Conditions
- Diabetes, Diabetic Foot, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- Trial name
- NCT03626623
- Testing
- Cytal Wound Matrix 1-Layer, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Integra LifeSciences Corporation
Arthritis, Rheumatoid Arthritis
Wright Foot & Ankle Post-Market Observational Study
WRIGHT FOOT \& ANKLE POST-MARKET OBSERVATIONAL STUDY, Multi-Year, Multi-Site, Multi-Device, Post-Market Observational Study, 10 sites, a minimum of 40 patients per device
- Conditions
- Arthritis, Rheumatoid Arthritis, Fracture, Trauma Injury
- Trial name
- NCT04118894
- Testing
- Foot and Ankle Devices
- Where
- 5 sites in United States, France and 2 more
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Stryker Trauma and Extremities
Diabetic Foot Ulcer
Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU)
The investigators aimed to elucidate the effects of UAW debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers as compared to diabetic foot ulcers receiving surgical/sharp wound debridement.
- Trial name
- NCT04633642
- Testing
- Ultrasound group, Surgical group
- Where
- 2 sites in Spain
- Volunteers
- 51 people
- Sponsor
- Universidad Complutense de Madrid
Diabetic Foot Ulcer
Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)
This is a Phase 2a Multi-Center, Prospective, Randomized, Controlled Study aimed to evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU)
- Trial name
- NCT06319287
- Testing
- PEP (Purified Exosome Product) / TISSEEL
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Rion Inc.
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
Chronic Diabetic Foot Ulcers
Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer
A PHASE 2a, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICALLY APPLIED BISPHOSPHOCIN NU-3 GEL TO CLINICALLY NONINFECTED CHRONIC DIABETIC FOOT…
- Trial name
- NCT05276401
- Testing
- 5% Bisphosphocin Topical Gel, 10% Bisphosphocin Topical Gel
- Where
- 5 sites in United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Lakewood-Amedex Inc