Clinical trials: Leg Injuries and Disorders
Spinal Cord Injuries
KAFO Orthoses Versus the ABLE Exoskeleton
This randomized crossover study will compare walking with KAFO type orthoses (current standard of care) versus the ABLE Exoskeleton device, during walking in patients with spinal cord injury in a hospital setting.
- Trial name
- NCT04855916
- Testing
- ABLE Exoskeleton, KAFO Orthosis
- Where
- Spain
- Volunteers
- 10 people
- Sponsor
- ABLE Human Motion S.L.
Diabetic Foot Ulcer, Pressure Injury
A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System
The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
- Conditions
- Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer, Surgical Wound
- Trial name
- NCT04593693
- Testing
- Invia Motion Endure NPWT system
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Medela AG
Wound
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact…
- Trial name
- NCT03877484
- Testing
- ALLEVYN Gentle border
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Wound Healing
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863
This is a randomized, placebo-controlled, single-blind (subjects and investigators will be blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part B) trial in healthy volunteers and subjects…
- Trial name
- NCT01831804
- Testing
- GSK1278863
- Where
- 7 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Venous Ulcer, Pressure Ulcer
Safety and Efficacy of the Fruit-based Product OPAL A for the Treatment of Chronic Venous and Pressure Ulcers
The purpose of this study is to examine the safety and efficacy of the fruit-based product OPAL A for the treatment of chronic venous and pressure ulcers.
- Trial name
- NCT00933348
- Testing
- OPAL A
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- Phoenix Eagle Company
Diabetic Foot, Arterial Occlusive Disease
Urokinase Therapy in Diabetic Foot Syndrome
The purpose of this study is to evaluate whether a treatment with urokinase (500 000 or 1 000 000 IU) can lead to ulcer-healing, lower rate of major amputation, and prolonged survival in patients with diabetic foot syndrome.
- Conditions
- Diabetic Foot, Arterial Occlusive Disease, Ischemia
- Trial name
- NCT00537498
- Testing
- Urokinase
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- medac GmbH
Skin Ulcer Venous Stasis Chronic
Clinical Trial to Investigate Efficacy and Safety of the IMP in Patients With Non Healing Wounds Originating From Ulcers
The aim of this clinical trial is to investigate the efficacy (by monitoring the wound size reduction) and safety (by monitoring occurring adverse events) of the investigational medicinal product APZ2 after one single application…
- Trial name
- NCT02742844
- Testing
- APZ2 application
- Where
- 2 sites in Germany
- Volunteers
- 13 people
- Sponsor
- RHEACELL GmbH & Co. KG
Hip Fractures, Osteoporosis, Postmenopausal
STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture
To evaluate the procedure and safety profile of the AGN1 Femoral LOEP Kit. This pilot study will be used to evaluate AGN1 Femoral LOEP treatment in a contralateral proximal femur during hip fracture repair.
- Trial name
- NCT03268356
- Testing
- AGN1 Femoral Local Osteo-Enhancement Procedure Kit
- Where
- Hong Kong
- Volunteers
- 13 people
- Sponsor
- AgNovos Healthcare, LLC
Diabetic Foot Ulcers
Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Wound Therapy
The study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.
- Trial name
- NCT00847730
- Testing
- V.A.C. Negative Pressure Wound Therapy System
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- KCI USA, Inc
Foot Ulcer, Diabetic
The Sorbact® Antimicrobial Dressing in the Holistic Wound Management Of Diabetic Foot ulCers (Phase III Study)
The aim of this study is to demonstrate, during a 12-week follow-up, a greater efficacy of using Sorbact® dressing technology in addition to best local cares compared to best local cares alone in the management of diabetic foot…
- Trial name
- ADHOC (NCT02334241)
- Testing
- Sorbact®, Best local cares
- Where
- 15 sites in Czechia, France and 1 more
- Volunteers
- 200 people
- Sponsor
- INRESA Pharma
Diabetic Foot Ulcer
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
The primary objective of this study is to determine the outcomes of patients who receive a certain type of skin substitute called RestrataTM Wound Matrix (Restrata™).
- Trial name
- NCT03312595
- Testing
- Restrata TM Wound Matrix
- Where
- 5 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acera Surgical, Inc.
Venous Ulcer
Effectiveness of XCell on Autolytic Debridement of Venous Ulcers
This clinical trial is designed to evaluate the effect of XCell cellulose wound dressing for its ability to naturally (autolytically) remove nonviable tissue and create a healthy vascular wound bed.
- Trial name
- XCell (NCT00446823)
- Testing
- XCell cellulose wound dressing, Impregnated gauze dressing
- Where
- 3 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Xylos Corporation
Diabetic Foot Ulcer
Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds
This is an IRB-approved multicenter study.This non-inferiority study aims to evaluate differential healing rates between Lavior Diabetic Wound Gel and other Hydrogels.
- Trial name
- RENEW (NCT05607979)
- Testing
- Lavior Diabetic Wound Gel, Smith & Nephew Solosite Gel Hydrogel Wound Dressing
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Lavior Pharma Inc.
Compartment Syndrome
Study of New Catheter & Pressure Monitor System to Help Prevent Compartment Syndrome From Developing in the Injured Leg
An investigation of a new catheter and pressure monitor system that may help to prevent a complication called compartment syndrome from developing in an injured leg.
- Trial name
- TS2 (NCT00681616)
- Testing
- Compartment Monitoring System (CMS), Compartment Monitoring System with Active Fluid Removal, Compartment Monitoring System without fluid removal
- Where
- 13 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Twin Star Medical, Inc.
Hip Fracture
A Proof-of-Concept Study Investigating the Safety and Efficacy of ZT-031 on Hip Fracture Healing in Men and Postmenopausal Women
The purpose of this research study is to test if an experimental drug called ZT-031 can help men over 30 years or post-menopausal women over 55 years of age with certain types of hip fracture to heal better or faster following…
- Trial name
- SHIFT (NCT00787358)
- Testing
- ZT-031
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Zelos Therapeutics
Venous Leg Ulcer (VLU)
ConvaVAC™ Ag+ Negative Pressure Wound Therapy System in Chronic Wounds
Purpose of this study is to learn more about how safe and effective the ConvaVAC™ Ag+ wound therapy system is in treating certain types of long-lasting wounds, called chronic wounds.
- Trial name
- ConvaVAC VLU (NCT07342049)
- Testing
- ConvaVAC™ Ag+ Negative Pressure Wound Therapy System
- Where
- 7 sites in Chile, United Kingdom
- Volunteers
- 87 people
- Sponsor
- ConvaTec Inc.
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
Diabetes, Diabetic Foot
Wound Assessment Using Spectral Imaging EU/UK
During the observational, non-interventional study, at Baseline Study Visit (BSV) subjects will be screened and consented. Eligible subjects will undergo imaging with the DeepView device.
- Conditions
- Diabetes, Diabetic Foot, Diabetic Foot Ulcer
- Trial name
- WAUSI EU/UK (NCT05581966)
- Testing
- DV-SSP Imaging
- Where
- Ireland
- Volunteers
- 72 people
- Sponsor
- SpectralMD
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