Clinical trials: Leg Injuries and Disorders
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Leg Ulcers Venous, Dehiscence, Surgical Wound
Blu Light for Ulcers Reduction
Multi-center study on the effectiveness of treatment with a blue light medical device (EmoLED) in the reduction of ulcer surface in 10 weeks.
- Trial name
- BLUR (NCT04018924)
- Testing
- Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)
- Where
- 7 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Emoled
Diabetic Foot Ulcer
Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers
This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied to diabetic ulcers in concert with professionally…
- Trial name
- NCT00764361
- Testing
- doxycycline
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- NanoSHIFT LLC
Diabetic Foot Ulcer
A Prospective, Randomized, Double-Blind Multicenter Study Comparing CDO Therapy to Standard MWT in the Treatment of DFUs
The purpose of this study was to evaluate the safety and effectiveness of Continuous Diffusion of Oxygen (CDO) therapy for the treatment of Diabetic Foot Ulcers.
- Trial name
- NCT01645891
- Testing
- CDO electrochemical tissue oxygenation system, Moist Wound Therapy
- Where
- 33 sites in United States
- Volunteers
- 146 people
- Sponsor
- Electrochemical Oxygen Concepts, Inc.
Deformity, Defect, Congenital
Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb
Orthofix Srl put the JPS on the European market (2019) by the mean of a pre-market clinical evaluation made under the Medical Device Directive (MDD) requirements that were based on the analysis of the scientific literature of…
- Conditions
- Deformity, Defect, Congenital, Trauma
- Trial name
- JPS (NCT05245617)
- Testing
- JuniOrtho™ Plating System™
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Orthofix s.r.l.
Foot Ulcer, Diabetic
A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
The primary objective is to: Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer.
- Trial name
- NCT01013792
- Testing
- Wound Dressing
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Solventum US LLC
Plantar Fasciitis, Flatfoot
Foot and Ankle Range of Motion (Stretching) Apparatus
Range of motion at ankle joint and subtalar joint will be assessed before and after utilization of ARM device. The changes in range of motion will be recorded and compared to literature.
- Conditions
- Plantar Fasciitis, Flatfoot, Calcaneus Fractures
- Trial name
- NCT00527748
- Testing
- Non-Measuring Ankle Exerciser
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Missouri-Columbia
Anterior Cruciate Ligament Injuries, Knee Osteoarthritis
Optimizing Movement After Anterior Cruciate Ligament Injury
Fifty percent of teenagers and young adults who suffer an anterior cruciate ligament (ACL) injury develop knee osteoarthritis (OA) within 15 years.
- Trial name
- NCT05363683
- Testing
- Squat Biofeedback, Standard Care
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- University of Nebraska
Shift-Work Sleep Disorder, Insomnia
Fire Fighter Fatigue Management Program: Operation Healthy Sleep
Firefighters work some of the most demanding schedules known under highly stressful and demanding conditions. The need to work frequent extended shifts and long work weeks leads to acute and chronic partial sleep deprivation as…
- Conditions
- Shift-Work Sleep Disorder, Insomnia, Restless Leg Syndrome, Obstructive Sleep Apnea
- Trial name
- NCT01988129
- Testing
- Sleep disorders education and screening
- Where
- United States
- Volunteers
- 1,189 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Diabetic Foot Ulcers
Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers
To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers.
- Trial name
- NCT00432965
- Testing
- Moist Wound Therapy, VAC Therapy
- Where
- 25 sites in United States, Canada
- Volunteers
- 335 people
- Sponsor
- KCI USA, Inc
Venous Ulcer of Leg
Intravascular Ultrasound-Guided Intervention for Venous Leg Ulcers (IGuideU)
This clinical study is a global, prospective, multi-center, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an interventional treatment guide will…
- Trial name
- IGuideU (NCT04696354)
- Testing
- IVUS, Continued Compression Therapy/Stockings
- Where
- 17 sites in United States, Australia and 3 more
- Volunteers
- 12 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Sickle Cell Leg Ulcer
Test of the Safety, Effectiveness, & Acceptability of An Improvised Dressing for Sickle Cell Leg Ulcers in the Tropics
One in 300 Jamaicans have HbSS sickle cell disease, and of these, up to 70% will suffer from sickle cell leg ulcers (SCLUs). Of these, 24% will have a chronic SCLU (one lasting longer than 6 months).
- Trial name
- SCLUJamaica (NCT04479618)
- Testing
- Usual Practice, Improvised dressing, Advanced dressing
- Where
- Jamaica
- Volunteers
- 48 people
- Sponsor
- Benskin, Linda, PhD, RN, SRN (Ghana), CWCN, CWS, DAPWCA
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.
Wound Open, Chronic Venous Hypertension (Idiopathic) With Ulcer
Efficacy of Laser Debridement on Pain and Bacterial Load in Chronic Wounds
Bacterial load is frequently associated with impaired healing of chronic wounds. As well, sharp debridement is often associated with pain, causing patient distress, and thereby occasionally contributing to inadequacy of…
- Conditions
- Wound Open, Chronic Venous Hypertension (Idiopathic) With Ulcer, Diabetic Foot Ulcer
- Trial name
- NCT03182582
- Testing
- Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement, Scalpel/Curette Debridement
- Volunteers
- 22 people
- Sponsor
- Stanford University
Venous Stasis Ulcers
Wound Fluid Protease Levels During Use of Novel Wound Dressing
This study is being conducted to characterize the way leg wounds respond to a new type of wound dressing, compared to wounds in patients who are not using the new dressing.
- Trial name
- NCT01567150
- Testing
- Novel Dressing
- Where
- 8 sites in United States
- Volunteers
- 35 people
- Sponsor
- Hollister Incorporated
Hip Fracture, Frailty
Starting a Testosterone and Exercise Program After Hip Injury
This study is a randomized controlled double-blinded multi-center clinical trial enrolling female hip fracture patients who are 65 and older.
- Conditions
- Hip Fracture, Frailty, Sarcopenia
- Trial name
- STEP-HI (NCT02938923)
- Testing
- Testosterone, Supervised exercise training, Home exercise program
- Where
- 8 sites in United States
- Volunteers
- 129 people
- Sponsor
- Washington University School of Medicine
Peripheral Arterial Disease, Intermittent Claudication
A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease
The goal of the proposed pilot study is to evaluate the feasibility of a new leg heat therapy system treatment for patients with lower extremity PAD.
- Trial name
- NCT05335161
- Testing
- Home-based leg heat therapy
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Purdue University
Venous Leg Ulcer, Mixed Leg Ulcer
Leg Ulcers Standards of Care Enhancement
Multi-center, prospective,randomized controlled study on the speed of healing, life quality and cost-effectiveness of the treatment with a blue light medical device (EmoLED) versus existing Standards Of Care (SOC) for patients…
- Trial name
- LUCE (NCT04689009)
- Testing
- EmoLED, current Standards Of Care
- Where
- 5 sites in Italy
- Volunteers
- 83 people
- Sponsor
- Emoled
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
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.